Claims:1. A Dietary composition with blend of Sesame oil and Rice Bran Oil that lowers blood pressure and lipids in hypertensive individuals comprising of 70-90% refined Rice Bran Oil & 30-10% unrefined Sesame Oil.
2. A Dietary composition as claimed in claim 1 with blend of Sesame oil and Rice Bran Oil that lowers blood pressure and lipids in hypertensive individuals comprising of 80% refined Rice Bran Oil & 20% unrefined Sesame Oil.
3. A process of preparing a dietary composition with blend of Sesame oil and Rice Bran Oil that lowers blood pressure and lipids in hypertensive individuals comprising the step of blending these two oils as per the desired ratios.

Dated this 2nd day of December, 2015.

________________________
GOPI J. TRIVEDI (Ms)
Patent Attorney
At Y. J. Trivedi & Co.
(Authorized Agent of the Applicant)
, Description:FORM – 2

THE PATENTS ACT, 1970
(39 of 1970)

COMPLETE SPECIFICATION
(SECTION 10, RULE 13)

“NOVEL BLEND OF EDIBLE OILS TO REGULATE HYPERTENSION, HYPER CHOLESTEROLEMIA AND HYPER GLYCEMIA”

ADANI WILMAR LIMITED
A Company Incorporated under the Indian Companies Act,
Fortune House, Nr. Navrangpura Railway Crossing,
Ahmedabad – 380 009, Gujarat State, INDIA.

The following specification particularly describes the invention and the manner in which it is to be performed:
Field of Invention:

The present invention relates to composition which is a novel blend of antioxidants rich edible vegetable oils to regulate hypertension, lipids and hyperglycemia in human by substituting or replacing conventional dietary fats. More particularly it relates to a novel blend of sesame oil and rice bran oil for regulating hyperglycemia, hypertension and hypercholesterolemia and a process of preparation thereof.

Background of the invention:

Diabetes and hypertension are chronic metabolic disorders, the incidence of which is gradually increasing in the Indian population. In many cases diabetes in itself gives rise to hypertension classified as secondary hypertension. A recent clinical survey carried out by the Cardiological Society of India has revealed the fact that 60% of the Indian populations have been affected by high blood pressure. Hypertension however is a multi-factorial disorder of which the causes cannot be determined with exactness. Diabetes is comparatively less complex with fewer variables. Both these diseases commonly have an abnormally elevated oxidative stress or lipid profile.

Diabetes is characterized by an increase in plasma glucose levels. This is caused by either decreased insulin production or reduction in insulin sensitivity or a combination of both. The resultant increase in plasma glucose levels causes progressive degeneration of vital body tissues leading to necrosis and eventually death. All Anti-diabetic medications attempt to reduce the plasma sugar levels and keep them close to normal. Antihypertensive regimens are also designed with a similar purpose to decrease and thus keep in check the blood pressure measurements. These would have worked fine if the medicines needed and doses required remained the same overtime. However, with the passage of time either the patient becomes less responsive to the medication or they become totally immune to it. This in turn requires increase in the dose of medication or a new medicine all together. Dose of medication can only be increased to a certain limit beyond which the effectiveness does not increase but toxicity does. Newer medications are not always readily available and thus limit the number of treatment options. The problem is compounded further by a sedentary life style with limited or no physical activity. The dietary intake however has either remained the same or increased disproportionately.

Over the past 50 years clinical research has been reported studying dietary fats and their role in modulating major species of plasma lipoproteins. A number of review articles have been written on the subject of coronary heart disease, controlling plasma cholesterol levels1, and specifically on the role of dietary fats in altering plasma lipoprotein levels2,3. Other research has studied the changes in lipoprotein levels resulting from dietary fats that are rich in various fatty acids. Tholstrup et al 4 have studied changes in lipoprotein levels resulting from diets rich in different saturated fatty acids including stearic acid (provided by Shea Butter), palmitic Acid (palm oil) and lauric and myristic acids (provided by palm kernel oil).

For over thirty years researchers have studied and compared different fatty acids for their abilities to raise or lower overall cholesterol levels in human plasma. While there are divergent opinions on many aspects of this subject, most nutritional experts agree that the saturated fatty acids (SFAs) raises total cholesterol levels (TC), while polyunsaturated fatty acids (PUFAs) lower them, and monounsaturated fatty acids (MUFAs), e.g., Oleic acid, are more neutral in their effect.
As a point of clarification and to avoid confusion, fats that contain mostly SFA are termed saturated fats (or SATS) while those fats containing mostly MUFAs are termed monounsaturated fats (or MONOS), and those fats containing mostly PUFAs are termed polyunsaturated fats (or POLYS). Beyond this simplistic view, it is also understood that metabolism of individual fatty acid species within each class, can impact high-density lipoprotein cholesterol (HDL-C) and low-density lipoprotein cholesterol (LDL-C) levels to different degrees.

Currently the commonly used cooking oils available in the market are soya bean oil, sunflower oil, mustard oil etc. These oils are used as cooking mediums however; they do not possess additional properties that would make them helpful in conditions like diabetes and hypertension. Therefore research was carried out to blend various naturally occurring edible vegetable oils that already possess some of the above mentioned properties.

Blended edible vegetable oils are covered by the Indian food laws (FSS Food Products Standards & Food Additives Regulations, 2011 Pt-1) under rule 2.2.1.24 wherein admixture of any two edible vegetable oils is allowed, with the proportion by weight of any edible vegetable oil used in the admixture being not less than 20% and the individual oils in the blend conforming to the respective standards prescribed by these rules.

Although many compositions and drugs have been developed and used to control hyperglycemia, hypertension and hypercholesterolemia, yet with most of the patients, therapeutic goals are still not achieved. Therefore, scientists continue to search for new, more effective treatment and other options for regulating blood sugar and blood lipids among diabetics and pre-diabetics and hypertensive patients. The development is always aimed at providing a system of least side effects to patients as well as most advantages. Hence there is a need to develop or invent new alternative to control hyperglycemia, hypertension and hypercholesterolemia.

Generally, usage of oil intake is not advisable to patients suffering from hyperglycemia, hypertension and hypercholesterolemia. Further, the taste of food is enhanced using oils that facilitate the intake of a balanced food to patients suffering from hyperglycemia, hypertension and hypercholesterolemia. There are certain oils which can be used by these patients but advised to be used sparsely. Moreover, they do not provide therapeutic or curing effects with their regular usage, but do not further increase the risk of hyperglycemia, hypertension and hypercholesterolemia. A need for an edible oil/oil blend is required to be developed which would be maintaining a balance between the not causing the problems to patients and retaining the taste of food using oil.

Oxidative stress is a major pathogenic factor in both diabetes and hypertension5. It has been reported that increased oxidative stress and it’s by products have direct correlation with the hypertensive cohort6. The development of insulin resistance associated with diabetes-induced hypertension was also reduced by chronic treatment with antioxidants5. Increased oxidative stress can cause ß-cell dysfunction followed decreased secretion of insulin, which leads to type 2 diabetes mellitus. Hypertension and type 2 diabetes mellitus in this case could be effectively controlled by treatment with antioxidants.

A study in albino rats has demonstrated inclusion of rice bran oil in the diet improves the antioxygenic potential and protect against oxidative stress thereby reducing symptoms of diabetes and hypertension7. Oxidative stress was induced in these animals by an intraperitonial administration of N-nitrosodiethylamine (NDEA). This resulted in weight loss in the rats and reduction in feed intake however the effect was much less pronounced in rats fed with rice bran oil diet. The animals fed with the rice bran oil diet showed a smaller decrease in catalase activity and a larger increase in peroxidase activity as compared to the non-rice bran oil fed group.

Studies in hamsters have shown that rice bran oil reduces cholesterol8. These hamsters were fed a diet containing rice bran and Rice bran oil unsaponifiable matter and compared with a control group of cellulose fed hamsters. After two weeks faecal fat and neutral sterol excretion were significantly greater with the treatment diet as compared to the control diet. Faecal fat was negatively correlated with liver as well as plasma cholesterol. Increased faecal excretion of fat and neutral sterols appears to be a possible mechanism for cholesterol-lowering by rice bran oil.

A study in rats has also demonstrated that rice bran oil increases insulin sensitivity after nicotinamide induced Type 2 diabetes mellitus9. Rats with streptozotocin/ nicotinamide-induced type 2 diabetes were divided into control, RO10, and RO15 groups, and fed cholesterol-free diets containing 0, 10, and 15 g rice bran oil with 0, 352, and 528 g ?-oryzanol and 0, 6.0 and 9.0 mg ?-tocotrienols/100 g diet for 4 weeks. Diabetic rats fed the rice bran oil diet had greater insulin sensitivity than rats fed the control diet. Diabetic rats fed the rice bran oil diet also had lower plasma triglycerides (TG), LDL-C and hepatic TG concentrations, as well as greater faecal neutral sterol and bile acid excretion than those fed the control diet4. After 4 weeks, there was an ;100% increase in the abundance of hepatic cholesterol 7a-hydroxylase, an 89% increase in the hepatic LDL-receptor, and a 50% increase in hepatic 3-hydroxy-3-methylglutaryl coenzyme A reductase mRNA in rats fed the rice bran oil diet compared with those fed the control diet. These findings support the conclusion that a rice bran oil–containing diet can significantly suppress hyperlipidemic and hyperinsulinemic responses in diabetic rats. The high contents of ?-oryzanol and ?-tocotrienols in rice bran oil can lead to increased faecal neutral sterol and bile acid excretion, via upregulation of cholesterol synthesis and catabolism.

Rice bran oil shows a substantial hypolipidemic effect in human’s also. Rukmini et al10 in their study with 12 subjects having high total cholesterol (TC) >225 mg/dl or high TG > 185 mg/dl after replacing their cooking oil with rice bran oil showed a significant reduction in total cholesterol (TC) and TG in 15 and 30 days. Suzuki et al11 in their study showed that a 30:70 ratio of safflower oil to rice bran oil can substantially lower high TC to normal limits with 7 days.

In comparison to sunflower oil, rice bran oil significantly reduces plasma cholesterol and triglycerides12. This study had a crossover design with 14 subjects randomly assigned to consume either rice bran oil or refined sunflower oil in their homes for a period of 3 months. After a washout period of three weeks they were crossed over to the other oil10. The serum lipids were measured at days 1, 45 and 90 for both oils.

Rice bran oil contains tocotrienols which are known to possess powerful hypocholesterolemic, anticancer and neuroprotective properties13. Structurally, natural vitamin E includes eight chemically distinct molecules: a-, ß-, ?- and d-tocopherol; and a-, ß-, ?- and d-tocotrienols. Symptoms caused by a-tocopherol deficiency can be alleviated by tocotrienols. Thus, tocotrienols may be viewed as being members of the natural vitamin E family not only structurally but also functionally. Palm oil and rice bran oil represent two major nutritional sources of natural tocotrienols. Taken orally, tocotrienols are bio available to all vital organs. The tocotrienol forms of natural vitamin E possesses powerful hypocholesterolemic, anticancer and neuroprotective properties that are often not exhibited by tocopherol. Oral tocotrienols protects against stroke-associated brain damage in vivo13.

A study using stabilized rice bran in Type 2 Diabetes Mellitus patients showed a significant reduction in HbA1c14. Twenty-eight volunteers with type 2 diabetes mellitus were randomly divided into 2 groups, one of which received a dietary supplement of 20 g of stabilized rice bran and the other placebo once daily for 12 weeks. Parameters such as the level of HbA1c, glucose, insulin, homeostasis model assessment for estimation of relative insulin resistance, HDL-C, LDL-C and adiponectin were evaluated. At the end of the study period, postprandial glucose and the area under the glucose curve of the rice bran group were significantly lower than baseline levels by 14.4 and 15.7%, respectively. Compared to baseline, the HbA1c values in the rice bran group were also significantly lower. Serum TC and LDL-C concentrations in the rice bran group were 9.2 and 13.7% lower, respectively, than in the placebo group. The plasma free fatty acid and adiponectin concentrations were 20% lower and 40% higher in the rice bran group compared to the placebo group. This study demonstrated that stabilized rice bran can lower the level of HbA1c and blood lipids and increase blood adiponectin concentrations in type 2 diabetic subjects.

Sesame oil consumption has been shown to have a beneficial effect on blood glucose, glycated hemoglobin (HbA1c), lipidperoxidation, and antioxidant levels in diabetic rats15. Diabetes was induced in adult female albino Wistar rats weighing 180–200 g by administration of STZ (Streptozotocin 40 mg/kg of body weight) intraperitonially. Both normal and diabetic rats were fed with a commercial diet containing 2% oil supplemented with 6% sesame oil for 42 days. Diabetic rats had elevated levels of blood glucose (322.61 ± 9.49 mg/dL), glycosylated haemoglobin, vitamin E, Thiobarbituric acid-reactive substances (TBARS), and lipid hydro peroxides and decreased levels of hemoglobin, vitamin C, and reduced glutathione (GSH). An increase in glucose-6-phosphatase and fructose-1, 6-bisphosphatase activities and a decrease in hexokinase activity were observed in liver and kidney tissues. When diabetic rats fed with sesame oil were compared with non-sesame fed diabetic rats, a significant reduction in levels of blood glucose (222.02 ± 8.27 mg/dL), (HbA1c), TBARS, and lipid hydro peroxides and glucose-6-phosphatase and fructose-1, 6-bisphosphatase activities was seen and an elevation in hemoglobin, vitamin E, and GSH levels and hexokinase activity were observed. Thus, sesame oil consumption influences beneficially the blood glucose, (HbA1c), lipid peroxidation, and antioxidant levels in diabetic rats.

A study in rats has also shown protective effect of sesame oil in reducing oxidative stress after onset of sepsis16. Sesame oil was given orally 6 hours after endotoxin administration and cecal ligation and puncture, and parameters were then measured in another 6 hours. The data demonstrated that a single dose of sesame oil reduced lipid peroxidation 6 hours after endotoxin intoxication. Superoxide anion counts were decreased, glutathione levels were increased, and activities of superoxide dismutase and catalase, as well as nitrite levels, were not altered in lipopolysaccharide plus sesame oil–treated groups compared with lipopolysaccharide-treated groups. Sesame oil was given 6 hours after cecal ligation and puncture significantly increased survival rate. Thus, sesame oil could be used as a potent antioxidant to reduce oxidative stress after the onset of sepsis in rats.

Studies in rats have also shown sesame oil to significantly boost vitamin E activity17. Vitamin E activity of sesame seed, which contains only ?-tocopherol, a compound that has vitamin E like activity equal to only 6-16% that of a-tocopherol, was examined in two experiments. In the first experiment, groups of rats were fed four diets: vitamin E-free control diet, a-tocopherol-containing diet, ?-tocopherol containing diet and sesame seed-containing diet. Changes in red blood cell haemolysis, plasma pyruvate kinase activity, and peroxides in plasma and liver, as indices of vitamin E activity, were examined. The sesame seed diet has high vitamin E activity, whereas this activity was low in the ?-tocopherol diet. In plasma and liver, a-tocopherol was found in high concentration only in the a-tocopherol-fed group, and ?-tocopherol was found in high concentration only in the sesame seed-fed group, with negligible amounts of ?-tocopherol in liver of the ?-tocopherol-fed group. In the second experiment, two diets containing sesame lignan (sesaminol or Sesamin) and ?-tocopherol were tested. Results in both of the sesame lignan-fed groups were comparable to those observed in the sesame seed-fed group in Experiment. These experiments indicate that ?-tocopherol in sesame seed exerts vitamin E activity equal to that of a-tocopherol through a synergistic interaction with sesame seed lignans.

Sesame oil has also been proven to reduce lymphatic absorption of cholesterol and fatty acids in rats18. Five groups of male Wistar rats weighing ~200 g consumed 12 or 24% sesame oil or coconut oil diets or a control diet (14% corn oil) ad libitum for 4 weeks. The thoracic ducts of these rats were cannulated, and a lipid emulsion containing [3H] cholesterol and [14C] oleic acid was given through a duodenal catheter. Lymph was collected for 24 hrs and the isotopic tracers for cholesterol and fatty acid were measured. Rats fed the 24% sesame oil diet had significantly lower lymphatic cholesterol and fatty acid compared with the control group. Absorption of oleic acid in rats fed 24% coconut oil was significantly greater than in controls during 0-8 hrs but was not significantly different during 0-24 hrs. There were no differences among groups in the distribution of cholesterol and oleic acid either in the lymph lipoproteins or in the lipid classes. The significant reduction in lymph cholesterol and fatty acids due to sesame oil feeding may be an important factor in reducing hypercholesterolemia.

A study in patients of Insulin resistance syndrome notably Type 2 diabetes mellitus and dyslipidaemia demonstrated a reduction in fasting blood glucose levels and blood pressure after consumption of sesame oil 19. In this study 40 newly diagnosed Type 2 diabetes patients were randomized into 2 groups. The experimental group used sesame oil as a cooking medium while coconut oil was used as a control for a duration of 2 months. All other parameters were maintained the same. Blood samples were analyzed for fasting blood glucose, TG, HDL-C, LDL-C and very low-density lipoprotein cholesterol (VLDL-C). Blood pressure measurements at the start of the study were in the range systolic 136+12 mmHg and diastolic 84± 8mmHg. After two months the mean BP readings were in the range 116± 7 mmHg systolic and 72 ±6 mmHg systolic13. Thus there was a significant reduction in blood pressure. There was a significant reduction in fasting blood sugar and TC. TG values showed no significant change.

A study in healthy Swedish women has shown an increase in serum ?-tocopherol levels after consumption of sesame oil20. Forty healthy female students (mean age 26 years) were randomly assigned to one of three groups and consumed a diet that contained one of the three oils Linola, Corn and sesame for 4 weeks. Refined oils were distributed as ingredients in specially prepared buns, in margarine or as dressing. Serum tocopherol, serum lipoproteins and plasma malondialdehyde concentrations were measured. The ?-tocopherol concentrations normalized to serum lipids increased significantly in the corn and sesame oil groups and a-/?- tocopherol ratios decreased significantly from baseline concentrations in all groups. The a-tocopherol concentrations did not change during the diet period in any of the three groups. Serum cholesterol, serum apolipoprotein B and plasma malondialdehyde concentrations decreased significantly only in the Linola oil group. These data show that a moderately modified natural diet that contains both a- and ?-tocopherol increases the serum ?-tocopherol concentration in healthy women without affecting the serum a-tocopherol concentration.

In Nifedipine-taking hypertensive patients, a dietary substitution of sesame oil has an additive effect in the reduction of blood pressure and plays an important role in the modulation of electrolytes and in the reduction of lipid peroxidation and elevation of antioxidants21,22. A sample of 396 hypertensive patients (aged 58 ± 3.8 years; 215 men and 181 women) participated in this study. Forty patients were treated only with Nifedipine while three hundred and fifty-six patients were treated with Nifedipine and instructed to use sesame oil in place of other edible oils for 60 days. The consumption of sesame oil remarkably reduced the (systolic and diastolic blood pressure from 166 ± 4.2 mmHg and 101 ± 3.1mmHg to 134.2 ± 3.4mmHg and 84.6 ± 3.0mmHg, respectively) blood pressure. The dosage of the drug also reduced, as there was a fall in blood pressure during sesame oil consumption. Plasma levels of sodium decreased while potassium and chloride increased significantly. TBARS level significantly decreased while activities of enzymic (superoxide dismutase, glutathione peroxidase and catalase) and concentrations of non-enzymic antioxidants (vitamin C, vitamin E, ß-carotene and reduced glutathione) increased in Nifedipine-sesame oil group. Nifedipine group showed a significant reduction in blood pressure, lipid peroxidation and improvement in reduced glutathione, however, the values are significantly lower than nifedipine-sesame oil group15. These results suggest that dietary substitution of sesame oil, in Nifedipine-taking hypertensive patients, has an additive effect in the reduction of blood pressure and plays an important role in the modulation of electrolytes and in the reduction of lipidperoxidation and elevation of antioxidants.

A study of sesame oil in hypertensive patients who were on antihypertensive therapy either with diuretics or ß blocker lowered blood pressure, decreased lipidperoxidation and increased antioxidant status23. Thirty-two male and 18 female patients aged 35 to 60 years old who were on antihypertensive therapy either with diuretics or ß-blockers were supplied sesame oil and instructed to use it as the only edible oil for 45 days. Blood pressure, anthropometry, lipid profile, lipidperoxidation, and enzymic and non-enzymic antioxidants were measured at baseline and after 45 days of sesame oil substitution. Substitution of sesame oil brought down systolic and diastolic blood pressure to normal. The same patients were asked to withdraw sesame oil consumption for another 45 days, and the measurements were repeated at the end of withdrawal period. Withdrawal of sesame oil substitution brought back the initial blood pressure values. A significant reduction was noted in body weight and BMI upon sesame oil substitution. No significant alterations were observed in lipid profile except triglycerides. Plasma levels of sodium reduced while potassium elevated upon the substitution of sesame oil. TBARS decreased while the activities of superoxide dismutase, catalase and the levels of vitamin C, vitamin E, ß-carotene and reduced glutathione were increased. The results suggested that sesame oil as edible oil lowered blood pressure, decreased lipidperoxidation, and increased antioxidant status in hypertensive patients.

A pilot study in Hypertensive Diabetic patients treated with ß blocker and sulfonylurea shows remarkable decrease in systolic and diastolic blood pressure, plasma glucose, HbA1c, total cholesterol, LDL-C and TG24. The open label trial with two intervention periods comprised 22 male and 18 female patients, 45–65 years old, with mild to moderate hypertension and diabetes using atenolol (ß-blocker) and glibenclamide (sulfonylurea). Sesame oil was supplied to the patients, who were instructed to use it in place of other cooking oils for 45 days. Blood pressure (BP), anthropometric measurements, plasma glucose, glycated hemoglobin (HbA1c), lipid profiles [TC, LDL-C, and HDL-C, and TG], TBARS, electrolytes (sodium, potassium, and chloride), and enzymic (superoxide dismutase, glutathione peroxidase, and catalase) and nonenzymic (vitamin C, vitamin E, ß-carotene, and reduced glutathione) antioxidants were measured at baseline and after 45 days of sesame oil substitution. The same patients were then switched over to other oils like palm or groundnut oils as their regular oils at random for another 45 days, and the investigations were carried out again at the end. Systolic and diastolic BP decreased remarkably. When oil substitution was withdrawn, BP values rose again. Body weight, body mass index, girth of waist, girth of hip, and waist to hip ratio were reduced upon substitution of sesame oil. Plasma glucose, HbA1c TC, LDL-C, and TG were decreased. TBARS level was reduced, while the activities of enzymic and the levels of nonenzymatic antioxidants were increased. Plasma sodium levels were reduced, while potassium levels were elevated. These results indicate that substitution of sesame oil as the sole edible oil has an additive effect in further lowering BP and plasma glucose in hypertensive diabetics.

After extensively reviewing the available body of scientific/clinical research data over to the management of high blood pressure/blood sugar, and keeping in view the economics, availability and logistics, the following oils have been selected for the Blend:

(1) Refined High Oryzanol contained Rice Bran Oil; & (2) Un-refined antioxidant lignans rich Sesame Seed Oil.

The present oil blend of sesame oil and rice bran oil is hereinafter referred to as sesame oil blend.

This blend indeed has demonstrated to be the most potential edible oil blend to address the issues for regulating hyperglycemia, hypertension and hypercholesterolemia. Though other blends of oils with different classes and ratios can be formulated, the results would not be so potential in regulating hyperglycemia, hypertension and hypercholesterolemia.. The facts have been extensively verified and the unique blend in specific ratios is unmatchable.

Object of the Invention:

The primary object of the present invention is to provide a novel blend of edible oils to regulate hyperglycemia, hypertension and hypercholesterolemia which is not a drug but an edible item generally consumed by all posing no adverse effect unlike the drugs.

Another object of the invention is to provide novel blend of edible oils to regulate hyperglycemia, hypertension and hypercholesterolemia which is easy and non-obnoxious to consume.

Still another object of the invention is to provide novel blend of edible oils to regulate hyperglycemia, hypertension and hypercholesterolemia which is made of natural ingredients.

Yet another object of the invention is to provide a novel blend of sesame oil and rice bran oil of very specific ratios for regulating hyperglycemia, hypertension and hypercholesterolemia.

Yet another object of the invention is to provide novel blend of edible oils to hyperglycemia, hypertension and hypercholesterolemia which can be consumed daily without the fear of increasing blood sugar, blood pressure and cholesterol.

The most important objective of the invention, therefore, is to investigate the relative effects of an oils blend-including cold pressed un-refined antioxidants lignans rich sesame oil and physically refined ?-oryzanol rich rice bran oil (20:80) on hypertension, hyperglycemia and lipids in individuals with hypertension or T2DM.

Further another object of the invention is to prepare a blend of very specific ratios comprising (1) Refined High Oryzanol contained Rice Bran Oil; & (2) Un-refined antioxidant lignans rich Sesame Seed Oil.
DESCRIPTION OF THE DRAWINGS:

Fig. 1 : Shows the present invention along with Diabetes Mellitus Project
Fig. 2 : Shows Changes in blood glucose and serum lipid levels in normal subjects and T2DM patients treated with sesame oil blend and T2DM patients treated with glibenclamide only and glibenclamide in combination with sesame oil blend during the study period.
Fig3(a)(i) : Changes in Fasting (A) and post prandial glucose (B) and HbA1c (C) levels in normoglycemic subjects and DM patients treated with sesame oil blend, DM patients treated with glibenclamide and DM patients treated with glibenclamide in combination with sesame oil blend (*, p<0.05, changes during the study period. †, p<0.05, differences between normal subjects and DM treated with sesame oil blend; #, p<0.05, differences between DM patients treated with glibenclamide and glibenclamide in combination with sesame oil blend)
Fig. 3a (ii) Changes in serum TC (A), TG (B), LDL-C (C) and HDL-C (D) levels in normoglycemic subjects and DM patients treated with sesame oil blend, DM patients treated with glibenclamide and DM patients treated with glibenclamide in combination with sesame oil blend (*, p<0.05, changes during the study period. †, p<0.05, differences between normal subjects and DM treated with sesame oil blend; #, p<0.05, differences between DM patients treated with glibenclamide and glibenclamide in combination with sesame oil blend)
Fig. 3b (i) Changes in systolic (A), diastolic (B) and mean arterial (C) pressure in normotensives and hypertensives treated with sesame oil blend, and hypertensives treated with nifedipine and nifedipine in combination with sesame oil blend (*, p<0.05, changes during the study period, assessed by a repeated measures analysis of variance. †, p<0.05, differences between normotensives and hypertensives treated with sesame oil blend groups; #, p<0.05, differences between hypertensives treated with nifedipine and nifedipine in combination with sesame oil blend
Fig. 3(b)(ii) Changes in serum TC (A), TG (B), HDL-C (C), LDL-C (D) and non-HDL-C (E) levels in normotensives and hypertensives treated with sesame oil blend, and hypertensives treated with nifedipine and nifedipine in combination with sesame oil blend (*, p<0.05, changes during the study period, assessed by a repeated measures analysis of variance. †, p<0.05, differences between normotensives and hypertensives treated with sesame oil blend groups; #, p<0.05, differences between hypertensives treated with nifedipine and nifedipine in combination with sesame oil blend)

DETAILED DESCRIPTION OF THE INVENTION:

PHYSICAL, CHEMICAL PROPERTIES AND FORMULATION

80% refined Rice Bran Oil & 20% unrefined Sesame Oil, which is the main crux of the invention is an oil blend that is light golden in colour and has a very high smoke point approximately 2540C. It has a mild flavour and is the least prone among cooking oils to turn rancid when left exposed due to the natural antioxidant present in it. It has a pleasant aroma. It is rich in ?-oryzanol, ?-tocotrienols, sesame lignans and unsaturated fatty acids.

A number of other compositions like changing the ratios of these two oils have been undertaken to identify the pronounced efficacy of the invented composition 80% refined Rice Bran Oil & 20% unrefined Sesame Oil. The other compositions selected are as follows:

(90% refined Rice Bran Oil & 10% unrefined Sesame Oil)
(85% refined Rice Bran Oil & 15% unrefined Sesame Oil)
(75% refined Rice Bran Oil & 25% unrefined Sesame Oil)
(70% refined Rice Bran Oil & 30% unrefined Sesame Oil)

It was expected that the same and desired results would be obtainable for the above compositions like the 80% refined Rice Bran Oil & 20% unrefined Sesame Oil. However, it was found out that the results provided by 80% refined Rice Bran Oil & 20% unrefined Sesame Oil as herein described below is unique and unmatchable and only it fulfills the objective of the invention and the other compositions with varied ratios fail to attend the desired level. Based on the results the innovator is motivated by the fixed ratios, 80% refined Rice Bran Oil & 20% unrefined Sesame Oil which requires to be protected and not the other ratios.

The composition of the blend of 80% refined Rice Bran Oil & 20% unrefined Sesame Oil is as follows:
SFA : 16%
MUFA : 43 %
PUFA (?6) : 40%
PUFA (?3) : 01%
Vitamin- E : ~400-ppm
Sesamin : ~1,000-ppm
Oryzanol : ~8,500-ppm

ROLE OF THE INDIVIDUAL NUTRIENTS IN THE INVENTED OIL BLEND:

(i) Fatty Acids and their Ratio: The American Heart Association (AHA) now recommends use of oils having an equal proportion of saturated, mono-unsaturated and poly-unsaturated fats. The World Health Organization (WHO) also recommends a PUFA: SFA ratio of 0.8-1.0. Also, consumption of polyunsaturated fatty acids should be accompanied by Vitamin-E or other natural antioxidants to prevent lipid peroxidation inside the body system.
?3 fatty acid (viz. Linolenic Acid, in this blend) has many biological effects that make them useful in preventing and managing chronic conditions like type-2 diabetes, hypertension, cardiovascular risk. In a diabetic diet it is recommended to provide 30 cal/kg body weight per day of which no more than 25% should be from oils and fats. Thus for a 60-kg body weight diabetes patient total calories to be supplied will be 1800 cal/day, of which 450 cal/day i.e. 52.5-gm can be from oils and fats. Considering that the suggested oil blend is used for this purpose, 52.5-gm of it will provide 525-mg ?3 fatty acid per day which is almost the entire requirement of this fatty acid by a diabetic person.

(ii) Natural anti-oxidants: As recommended by various health organizations, natural antioxidants retard peroxidation of PUFA in the body system. According to the free radical theory of aging, it is the shift in the antioxidant/pro-oxidant balance that leads to increased oxidative stress, dysregulation of cellular function and aging. Tocopherol / Tocotrienols (Vitamin E), Sesamin and Oryzanol are all very powerful natural antioxidants that prevent peroxidation of the PUFA present in the suggested blend, both during storage/cooking as also inside the body.

(iii) Sesamin: It is a lignan, and it binds to and activates a receptor called Peroxisome Proliferator-Activator Receptor Alpha (PPAR alpha). This activation increases gene expression of the fatty acid oxidation enzymes and decreases gene expression of lipogenic enzymes. Thus, Sesamin increases fat breakdown via oxidation and decreases fat storage in the body. Sesamin has also been shown to be antihypertensive; to increase regeneration and recycling of vitamin-E and decrease LDL-c levels while increasing the HDL-C.

(iv) Oryzanol: It is a powerful antioxidant, more powerful than vitamin E in fighting free radicals. Oryzanol is effective in lowering cholesterol levels in the blood, reducing cholesterol biosynthesis in the liver, and treating menopausal disorders.
Thus, the suggested blend of 80% refined Rice Bran Oil & 20% unrefined Sesame Oil is expected to possess far reaching health benefits in persons having any one or more of the chronic conditions like hypertension, diabetes (type-2) and dyslipidemia.

The vast majority of data on the benefits of sesame oil and rice bran oil on CVD have been obtained when given individually. However, no study has been conducted so far to examine the combined effect of blending these two oils as cooking oil in hypertensive patients. Based on the functional efficacies of sesame oil and rice bran oil over to lowering hyperglycemia and lipids, a novel oils blend with rich source of antioxidants, MUFAs and PUFAs, provide increased opportunities for optimizing the unsaturated fatty acids/antioxidants as dietary supplement to improve hypertension, diabetes and associated cardiovascular risk factors. It was hypothesized that a blend of sesame oil and rice bran oil would elicit different effects that they reflect individually as cooking oil. What remains to be evaluated are the nutritional impact of a blend of sesame oil and rice bran oil in hypertensive patients and patients with diabetes mellitus.

Sesame oil is rich in poly (44%) and mono unsaturated fatty acids (40%), which are considered as “good fats”. Sesame oil has been found to contain substantial amounts of the sesame lignans, sesamin, sesamol, episesamin, and sesamolin. The lignans present in sesame oil are thought to be responsible for many of its unique chemical and physiological properties, including its antioxidant, antidiabetic and antihypertensive properties. It has natural antioxidants like vitamin E and antioxidant lignans. Sesame oil can be used in cooking or as dressing for different salads and not only does it has a delicious nutty taste it also has an ability to stay fresh without going rancid for long periods of time.

In addition, it is also very rich in monounsaturated fats, and polyunsaturated fats, so besides being beneficial for blood pressure, it's actually also good for your blood cholesterol, so overall, sesame oil is a very heart healthy oil, and it's very tasty also. The effect of the oil on blood pressure may be due to PUFA, vitamin E and the antioxidant lignans (sesamin and sesamol) present in sesame oil.

Using sesame oil as the sole cooking oil for 60 days along with drug treatment lowered patient’s blood pressure levels from 166mmHg systolic blood pressure (the top number in a blood pressure reading) to 134 mmHg, and from 101 mmHg diastolic (the lower number) blood pressure to 84.6 mmHg. The dose of the antihypertensive drug, nifedipine, a calcium channel blocker, was reduced from 22.7 mg per day to 7.45 mg per day by the end of the study, and the other study, it looked at people who were taking either beta blockers or diuretics, and found a very similar effect. After forty five days, these people had their blood pressure drop down to normal levels. To see what would happen if they resumed their normal eating habits, they went back to their regular cooking oil, and their blood pressure increased again, so once again, they put them on the sesame seed oil, just their normal eating habits. Their blood pressure dropped back down to normal, so this is very promising. It's actually showing that sesame oil has a very potential benefit, for lowering blood pressure.

Substituting sesame oil for other cooking oils that contain unhealthy saturated fatty acids might enhance the diabetes drug’s ability to lower blood glucose and blood lipids. The speculations proved to be well-founded. The group that utilized sesame oil and consumed glibenclamide experienced a 36% reduction in fasting blood sugar at the end of the study period. Further, this same group saw a 22% drop in total cholesterol, a 38% drop in LDL-C, and a 15% drop in TG levels. Interestingly, the group that utilized sesame oil alone (i.e., no diabetes drugs) also experienced significant improvements on all of these measures including a 15% drop in fasting blood sugar, 19% lower total cholesterol, 32% reduced LDL-C, and a 14% drop in triglycerides.

Sesame oil is an excellent source of poly and mono unsaturated fatty acids including omega-3 and omega-6. Polyunsaturated fatty acids are necessary for growth and development and strong evidence supports their role in the prevention and treatment of chronic diseases such as coronary heart disease, hypertension, diabetes and arthritis. Sesame oil has been shown to help lower blood pressure, lower blood sugar, and increase good cholesterol, decrease bad cholesterol and triglycerides levels in the blood.
Because sesame oil is all natural and doesn't contain any harmful ingredients, it can be used with confidence in cooking as there have been lots of benefits in health and diseases. It's a good oil to use for cooking. It gives foods lots of different flavors, so definitely keep sesame oil in mind, so that's just well-liked information for people, for sesame oil, and how it affects your blood pressure and diabetes.

Rice bran oil is the oil extracted from the germ and inner husk of rice. Rice bran constitutes about 10% of rough rice grain and contains 18% - 22% oil. The oil is pale yellow, limpid (at 20°C), and odourless with an acid index of <0.50, density at 20°C between 0.920 and 0.930, refractive index at 20°C between 1.471 and 1.475, smoke point >200°C, and a pleasant, lightly sweet flavour. It contains oleic acid (38.4%), linoleic acid (34.4%) and a-linolenic acid (2.2%) as unsaturated fatty acids, and palmitic (21.5%) and stearic (2.9%) acids as saturated fatty acids. Rice bran oil contains a range of fats, with 47% of its fats monounsaturated, 33% polyunsaturated , and 20% saturated. Rice bran oil is rich in vitamin E , ? -oryzanol (an antioxidant that may help prevent heart attacks, and phytosterols (compounds believed to help lower cholesterol absorption), which may provide associated health benefits.

In contrast to most common refined vegetable oils, crude rice bran oil contains a rich unsaponifiable fraction (up to 5%) mainly composed of sterols (43%), triterpene alcohols (28%) 4-methyl-sterols (10%) and less polar components (19%). Phytosterols include ß-sitosterol (900 mg%), campesterol (500 mg%), stigmasterol (250 mg%), squalene (320 mg%) and ?-oryzanol (1.6%). ?-oryzanol is a mixture of ferulic acid esters of triterpene alcohols such as cycloartenol. Rice bran oil contains a small variable quantity of tocotrienols (72–612 ppm, especially ß- and ?-tocotrienols). Moreover, rice bran oil is naturally very rich in a-tocopherol (ca. 100 mg%)

Rice bran oil is rich in ?-oryzanol, a group of ferulate esters of triterpene alcohols and phytosterols. The high antioxidant property of ?-oryzanol has been widely recognized. ?-oryzanol in rice bran oil has purported health benefits. Studies have shown several physiological effects related to ?-oryzanol and related rice bran oil components.

Rice bran oil and its main components (unsaturated fatty acids, triterpene alcohols, phytosterols, tocotrienols, a-tocopherol) have demonstrated an ability to improve the plasma lipid pattern of rodents, rabbits, non-human primates and humans by reducing total plasma cholesterol and triglyceride concentration and increasing the high density lipoprotein cholesterol level. Other potential properties of rice bran oil and ? -oryzanol, studied both in vitro and in animal models, include modulation of pituitary secretion, inhibition of gastric acid secretion, antioxidant action and inhibition of platelet aggregation. Rice bran oil also improves immune response.

The rice bran oil tastes pleasant (slightly sweet) and is suitable for frying food because of its high smoke point. This property is may be related to the relatively high content of 4-monomethylsterols with an ethylidene side chain which possibly contribute to its oxidative stability. Finally, suggest that rice bran oil could be considered an additional weapon in the management of mild to moderate hypercholesterolemia.

The inventors of the present invention invented that instead of using sesame oil and rice bran oil individually, if they are used in combination the more pronounced synergistic effect in health and disease can be observed. Sesame and rice bran oils are excellent source of polyunsaturated fatty acids including omega-3, omega-6 and omega-9. Polyunsaturated fatty acids are necessary for growth and development and strong evidence supports their role in the prevention and treatment of chronic diseases such as coronary heart disease, hypertension, diabetes and arthritis. Sesame oil has been shown to help lower blood pressure, increase good cholesterol, decrease bad cholesterol levels and help maintain normal blood pressure levels. These effects have been primarily ascribed to the naturally high polyunsaturated fat content and the antioxidants like sesamin, sesamol, sesamolin and vitamin E found in sesame oil. Rice bran oil exerts great potential of improving lipid abnormalities, hyperinsulinemia and increased immune response. An array of rich unsaponifiable fractions include sterols, triterpene alcohols and phytosterols include ß-sitosterol, campesterol, stigmasterol, squalene and ?-oryzanol are also responsible for its impact in health and diseases.

Since Sesame oil and rice bran oil are having unique biological and physiological properties, composition of these two oils will certainly endow with more pronounced synergistic effect in health and diseases. The health effect of sesame oil and rice bran oil are rather incredible and consist of largely of scientific evidences for health benefits. The evidence to date suggests that sesame oil and rice bran oil may play a significant role in the prevention and treatment of chronic diseases.

The present invention also provides method of manufacturing the novel blend of sesame oil and rice bran oil. The method mainly includes blending of the sesame oil and rice bran oil in appropriate proportions to achieve the desired result.
Experiments and trials for evaluation of the potentiality of the invented composition:
In this prospective, randomized, open-label dietary intervention, 300 hypertensive patients (mean age, 57 years; 160 men; 140 women) were equally randomized for 60 days to one of the three groups: 1) calcium channel blocker 30 mg/d; 2) sesame oil and rice bran oil blend; 3) sesame oil and rice bran oil blend + calcium channel blocker 30mg/d. The patients except group 1 were supplied with sesame oil and rice bran oil blend and instructed to use ~35-40mL of oil/day/person for cooking, salad preparation etc., Blood pressure was measured at baseline, and after 15, 30, 45 and 60 days, respectively. Lipid profile was measured at baseline and at the end of 60 days.
Results of Experiments and trials:
Calcium channel blocker or sesame oil and rice bran oil blend or combination of calcium channel blocker and sesame oil and rice bran oil blend induced significant fall of systolic/diastolic blood pressure [SBP 11% mmHg, 12% mmHg and 23.8% mmHg/DBP 12% mmHg,13% mmHg and 23.6% mmHg, respectively vs baseline). Calcium channel blocker and sesame oil and rice bran oil blend combination induced greater reduction and the dose of the drug was also reduced as there was remarkable fall in blood pressure. Total cholesterol, LDL cholesterol and triglycerides levels in the blood were significantly reduced while HDL cholesterol levels increased in sesame oil and rice bran oil blend alone (18%, 28%, 12.6% and 11%, respectively vs baseline) or combination therapies (20%, 29%, 14% and 12% respectively, vs baseline).
It has been observed that for the first time that dietary intervention with blends of sesame and rice bran oils lowers blood pressure and lipids in hypertensive individuals. Furthermore, results suggest that the reduction of blood pressure and lipids have important implications for population health and lowering the risk of stroke and ischemia.
BLEND OF SESAME OIL AND RICE BRAN OIL FAVOURED GLYCEMIC CONTROL AND LIPIDS IN PATIENTS WITH TYPE 2 DIABETES MELLITUS:

Participants: Men and women (n=300) with newly diagnosed T2DM, with a mean (±SD) age of 50.5±10.8. Apparent normoglycemic subjects (n=100) were also recruited, with mean (±SD) age of 32.6±10. Eligible normoglycemic subjects were men and women, with normal plasma glucose levels. T2DM patients were required to have no evidence of cardiovascular or liver disease; usage of anti-diabetic or cholesterol-lowering medication; adherence to a prescribed diet; and pregnancy or lactation.

Study design: The study was designed as 8-wk randomized open-label dietary intervention, and the eligible T2DM patients and normoglycemic subjects referred by the diabetes outpatient clinics of the Hindu Rao Hospitals, New Delhi, India and Dr. Ambedkar Multispecialty Hospital, Noida, India were randomized to the following treatment groups as i) normoglycemic subjects treated with sesame oil blend (n=100), ii) T2DM patients treated with sesame oil blend (n=100), iii) T2DM patients treated with glibenclamide (n=100; 5mg/d), and iv) T2DM patients treated in combination of glibenclamide (5mg/d) and sesame oil blend (n=100). All the participants were clinically assessed at baseline for 12hr fasting plasma glucose, HbA1c, TC, TG, LDL-C, and HDL-C followed post prandial glucose evaluation. After the blood chemistry analysis, sesame oil blend was supplied to the respective groups at every 2-wk interval for a maximum of 4-5 liters. The normoglycemic subjects and the T2DM patients supplied with the sesame blend were instructed to use it as the only cooking oil in place of other cooking oils, they have used before their inclusion in the study, for 8 wk. In accordance with the daily requirement of calorie by fat, we advised the participants that their daily use of the sesame oil blend per person/day for cooking should not exceed 35-40mL. T2DM patients treated with glibenclamide alone or in combination with sesame oil blend were asked to continue their medication for 8-wk. Fasting plasma glucose and post prandial glucose levels were measured at wk-4 and wk-8 while HbA1c and TC, TG, LDL-C and HDL-C were measured at wk-8.

The ethical committee of the International Institute of Stress Management and Allied Sciences (IISMAS), New Delhi, India approved the study protocol. All participants gave informed consent before the initial screening of the study and they were free to decide whether to participate or stop the study protocol at any stage of the study period.

Statistical analysis: Data analyses were done by using the SAS Software (Ver. 9.2, SAS Institute Inc., Cary, NC, USA). Changes in continuous variables during the study period for each group were examined by repeated measures of analysis of variance (ANOVA). Differences in continuous variables between groups were examined by an ANOVA. Patterns of changes between groups were examined by a two-way repeated measure of ANOVA. Changes at wk-8 of the study period vs baseline for each group were examined by Wilcoxon signed-rank test. Differences in changes between groups at wk-8 of the study period vs baseline were examined by Wilcoxon rank-sum test. Data are presented as the mean ? standard deviation (SD).

Results: The baseline data of the study participants were detailed in Table 1. T2DM patients were randomly assigned to the 1 of the 3 intervention groups, where as the normoglycemic subjects were grouped as normal control for sesame oil blend. All the participants completed the study and the compliance was assessed according to the participants reports, and none was classified as non-compliant. No significant differences were observed at baseline values for body weight, W/H ratio and BMI between T2DM patients of each of the 3 treatment groups. Likewise, we found no significant differences in the basal values for life style habits of T2DM patients such as smoking, alcohol consumption, betel nut chewing and physical activity.

Pre- and post treatment values of fasting and post prandial glucose, TC, TG, LDL-C and HDL-C were summarized in the Table 2, and Figure 1, 2 & 3. T2DM patients treated with sesame oil blend or glibenclamide produced significant reduction of fasting and post prandial glucose (p<0.001) at wk-4 and wk-8. However, highest reduction of fasting and post prandial glucose (p<0.0001) was noted in T2DM patients treated in combination of glibenclamide and sesame oil. Likewise, HbA1c was significantly reduced in sesame oil blend or glibenclamide or combination groups at wk-8. T2DM patients treated with sesame oil blend or treated in combination of glibenclamide and sesame oil blend showed a significant reduction of TC, TG, LDL-C and increase of HDL-C concentrations from pretreatment baseline concentrations. However, the changes in TC, TG, LDL-C and HDL-C did not differ significantly between sesame oil blend alone and the combination treatments.

Use of sesame oil and rice bran oil blend as cooking medium showed a notably beneficial effect on glycemic control and lipids in patients with T2DM. Moreover, combination of sesame oil blend and glibenclamide treatment in these patients produced highly significant improvement of hyperglycemia. These findings could be of clinical relevance for the development of prevention strategies in the population at risk of type 2 diabetes and future CV risk.

BLEND OF SESAME OIL AND RICE BRAN OIL LOWERED BLOOD PRESSURE AND IMPROVED LIPIDS IN MILD-TO MODERATE HYPERTENSIVES:

Participants: Men and women aged 40-60 years who had essential hypertension for > 3 months were recruited from the general community with similar socio-economic and lifestyle patterns. Entry criteria included a persistent high blood pressure; SBP > 140 mmHg, DBP > 90 mmHg. Subjects were excluded if they had secondary hypertension; recent history of heart disease, angina, or major surgery; or had a recent history of myocardial infarction or stroke; or had significant liver or renal disease. Lifestyle habits of the study participants, including smoking, alcohol intake and physical activity were obtained by a questionnaire. The family history of hypertension was defined as a history of those whose mothers or fathers were once diagnosed having hypertension. We invited one hundred and fifty normotensives, and four hundred consecutive hypertensive patients who were not on antihypertensive medication for at least four weeks and were referred for blood pressure monitoring to the Hypertension Clinics of Hindu Rao Hospitals, New Delhi, India and Dr. Bhimrao Ambedkar Multi Specialty Hospital, Noida, India. Of those invited, three hundred hypertensives and one hundred normotensives provided their consent to participate in the study. Subjects were informed about the objectives, methods and the potential benefits of the sesame oil blend. The study protocol was approved by the Ethics Committee of International Institute of Stress Management And Allied Sciences (IISMAAS), New Delhi, India.

Study design: Baseline (0day) measurements included SBP, DBP and mean arterial pressure (MAP), anthropometric data and 12hr overnight fasting serum lipid profile (TC, LDL-C, TG, non-HDL-C and HDL-C) were done during which all subjects maintained their usual diet. Hypertensives and normotensives were assigned to 4 groups: i) normotensives with sesame oil blend (n=100), ii) hypertensives treated with nifedipine (n=100), a known antihypertensive calcium channel blocker drug (20mg/d), iii) hypertensives treated with sesame oil blend (n=100), and iv) hypertensives treated with combination of sesame oil blend and nifedipine (20mg/d; n=100). The normotensive and hypertensive groups except the nifedipine alone treated-hypertensive group were supplied with the unsaturated and antioxidants rich sesame oil blend (Table 1) 4-5 liters for a four-five member family/month and they were instructed to use the oil blend as the only source of cooking oil in place of other edible oils for 60 days. They were advised to adhere to the recommended daily consumption of oil 35-40ml of sesame oil blend/person/day. Hypertensives, if prescribed with nifedipine, were asked to continue the medication for 60 days. Blood pressure was measured at days 15, 30, 45 and 60. Lipid profile was measured again at the end of 60th day.

Statistical data analyses: All of the data analyses were performed using the SAS (Statistical Analysis System) Software Package (Ver. 9.4, SAS Institute Inc., Cary, NC, USA) at Fukuoka University, Fukuoka, Japan. Changes in continuous variables during the study period for each group were examined by repeated measures of analysis of variance (ANOVA). Differences in continuous variables between groups were examined by an ANOVA. Patterns of changes between groups were examined by a two-way repeated measure of ANOVA. Changes at day 60 of the study period vs baseline for each group were examined by Wilcoxon signed-rank test. Differences in changes between groups at day 60 of the study period vs baseline were examined by Wilcoxon rank-sum test. Data are presented as the mean ? standard deviation in the tables described below.
Table 3a (i) describes Changes in blood glucose in normoglycemic subjects and DM patients treated with present oil blend.

Table 3a (i)
Normal subjects + Sesame oil blend Type 2 diabetes + Sesame oil blend
0 day 60 days 0 days 30 days 60 days
S.No FBG PPG FBG PPG S.No FBG PPG FBG PPG FBG PPG
1 70 122 74 110 1 192 247 170 220 155 190
2 86 120 81 118 2 150 234 142 200 140 146
3 82 122 72 122 3 190 290 160 250 152 212
4 77 120 79 120 4 144 230 122 200 112 180
5 90 100 98 118 5 176 284 157 266 146 212
6 87 122 87 111 6 140 210 130 190 128 147
7 67 126 77 122 7 200 290 126 200 116 155
8 89 105 76 100 8 200 280 135 250 136 220
9 102 122 100 118 9 195 340 170 280 160 270
10 91 124 100 124 10 140 208 136 190 130 180
11 88 125 98 122 11 140 190 132 183 130 181
12 99 116 100 134 12 142 222 136 200 135 154
13 100 118 98 124 13 148 190 130 168 132 145
14 98 122 98 152 14 150 226 129 160 137 161
15 100 121 96 117 15 150 256 152 212 150 154
16 89 99 88 122 16 190 246 140 190 141 151
17 78 111 80 124 17 154 234 125 190 122 140
18 96 124 90 122 18 200 256 133 178 130 145
19 98 122 90 118 19 170 224 144 190 125 138
20 90 135 96 130 20 176 244 144 164 120 144
21 97 102 95 105 21 150 190 124 166 123 130
22 88 99 86 100 22 146 200 135 198 134 145
23 96 123 100 120 23 200 244 130 200 144 135
24 108 122 105 118 24 200 244 130 200 156 140
25 100 120 99 122 25 188 256 144 152 146 150
26 99 132 98 120 26 176 256 145 232 150 163
27 96 128 95 122 27 160 226 154 220 151 156
28 94 124 90 120 28 162 244 158 186 155 184
29 100 124 96 112 29 150 200 144 190 142 149
30 103 112 100 118 30 164 212 158 200 157 172
31 108 120 109 120 31 190 266 150 242 148 154
32 100 120 98 138 32 169 245 130 231 134 142
33 98 124 100 122 33 212 266 139 234 138 145
34 100 139 98 140 34 200 278 133 244 144 140
35 85 122 88 99 35 200 245 141 224 140 142
36 90 118 86 100 36 200 280 190 299 188 200
37 99 102 98 104 37 200 224 177 216 175 198
38 79 120 80 100 38 200 260 165 254 163 250
39 78 118 82 118 39 155 240 155 242 152 198
40 75 118 89 114 40 168 210 169 204 167 190
41 85 120 90 118 41 187 244 184 223 183 183
42 86 122 100 120 42 155 244 142 220 140 155
43 100 126 99 124 43 155 210 150 208 149 205
44 79 100 80 118 44 210 260 206 254 204 250
45 102 130 90 128 45 230 300 222 298 200 144
46 100 130 98 122 46 199 240 190 230 188 225
47 100 132 98 120 47 189 240 188 234 174 170
48 98 130 98 128 48 200 244 145 224 144 156
49 88 122 90 120 49 185 234 165 188 163 190
50 90 101 88 100 50 201 240 198 232 180 230
51 98 103 96 102 51 208 250 195 245 193 244
52 99 116 96 114 52 200 256 176 240 174 288
53 96 130 100 120 53 214 244 216 238 188 236
54 98 135 90 109 54 180 250 173 225 170 184
55 108 134 99 100 55 207 250 201 245 190 240
56 96 132 90 120 56 190 256 195 248 193 244
57 98 112 96 110 57 197 244 195 230 192 225
58 85 100 88 105 58 169 230 166 199 165 164
59 88 122 90 120 59 168 201 167 195 160 194
60 90 122 88 122 60 169 200 165 188 164 175
61 102 120 90 118 61 178 234 177 212 174 190
62 96 132 100 124 62 187 237 178 220 177 175
63 100 130 100 122 63 169 205 159 199 155 200
64 98 136 90 124 64 168 206 165 200 162 198
65 100 132 90 136 65 189 241 178 235 177 198
66 94 150 90 118 66 198 258 195 246 180 200
67 100 122 90 122 67 180 230 174 224 172 190
68 90 100 88 116 68 170 210 166 207 165 189
69 98 128 98 126 69 179 224 172 200 170 178
70 95 132 96 132 70 144 190 155 180 132 150
71 96 120 95 118 71 168 222 162 218 160 216
72 92 130 90 125 72 199 260 193 256 144 250
73 89 128 90 120 73 189 290 183 246 140 288
74 90 100 98 100 74 156 244 122 200 128 160
75 94 120 110 100 75 200 243 153 212 160 156
76 95 120 98 100 76 156 234 144 200 144 165
77 78 120 89 100 77 169 204 166 188 165 195
78 90 122 98 122 78 188 256 178 200 175 199
79 102 128 90 124 79 204 268 199 243 195 220
80 90 122 95 130 80 210 280 203 275 164 260
81 90 100 90 145 81 219 256 215 252 160 234
82 100 126 98 124 82 160 200 144 195 133 194
83 98 120 100 124 83 170 250 152 245 140 200
84 100 120 100 126 84 200 266 200 234 170 190
85 100 122 100 124 85 178 234 175 200 144 190
86 98 134 100 130 86 176 244 152 238 144 200
87 101 126 100 122 87 189 200 185 195 166 180
88 100 124 100 118 88 210 250 204 247 202 232
89 98 120 96 119 89 180 260 174 250 150 232
90 97 112 98 120 90 180 256 140 220 140 200
91 85 122 84 118 91 190 240 166 234 144 190
92 80 120 88 132 92 160 244 155 198 145 200
93 78 120 77 134 93 180 244 155 226 144 185
94 89 120 88 124 94 180 245 146 220 134 180
95 98 120 99 120 95 190 244 140 212 148 200
96 89 134 90 122 96 180 256 166 200 145 163
97 90 128 88 122 97 166 234 150 220 150 200
98 90 136 90 122 98 190 240 155 232 142 195
99 98 140 90 138 99 166 238 164 220 142 205
100 98 109 98 110 100 190 270 163 246 150 233

Table 3a (ii) describes Changes in BP in normotensives and hypertensives treated with sesame oil blend.

Table 3a (ii)
Normotensives + Sesame oil blend Hypertensives + Sesame oil blend
0 day 60 days 0 day 15 days 30 days 45 days 60 days
S. No SBP DBP SBP DBP S. No SBP DBP SBP DBP SBP DBP SBP DBP SBP DBP
1 120 80 118 78 1 144 100 140 98 140 86 138 86 136 90
2 118 78 120 78 2 150 100 144 100 140 98 134 88 144 90
3 122 82 118 80 3 180 100 170 100 160 84 156 84 156 84
4 116 84 116 82 4 180 110 170 100 170 90 150 90 144 90
5 120 80 118 80 5 160 100 156 100 144 96 144 90 150 94
6 120 88 122 84 6 165 100 150 100 146 98 144 98 136 96
7 120 80 116 82 7 170 100 166 96 160 94 160 94 130 92
8 118 80 116 84 8 144 100 140 100 134 90 134 88 144 86
9 110 78 114 80 9 156 100 144 96 140 94 142 94 130 90
10 126 80 122 82 10 150 100 146 94 140 94 144 94 144 88
11 132 70 130 72 11 166 108 156 100 134 90 134 90 140 88
12 118 78 120 78 12 156 100 144 100 140 100 138 88 150 90
13 124 84 120 80 13 146 100 144 100 144 90 144 90 144 90
14 122 82 118 80 14 152 110 150 100 140 98 146 90 132 90
15 120 80 116 78 15 150 100 146 98 150 92 144 92 130 88
16 118 78 120 78 16 178 110 160 96 150 94 140 94 130 88
17 120 80 122 80 17 180 100 160 98 156 96 144 96 160 100
18 112 80 118 76 18 180 100 170 100 160 96 156 90 160 90
19 120 82 120 84 19 178 110 160 100 156 98 144 86 156 90
20 118 80 116 78 20 188 110 180 100 170 98 150 88 156 90
21 126 80 122 84 21 142 100 138 98 130 90 138 90 150 98
22 112 80 118 80 22 150 100 144 100 144 96 140 84 134 82
23 120 80 116 78 23 166 108 160 98 156 96 150 84 140 82
24 124 84 120 82 24 180 110 144 100 140 100 140 94 134 94
25 116 84 118 82 25 160 106 150 100 144 100 140 94 140 92
26 122 82 120 80 26 166 108 150 98 144 96 140 96 144 92
27 116 84 116 80 27 158 100 144 100 144 94 140 86 156 84
28 120 80 118 80 28 160 106 160 100 150 90 144 100 144 84
29 120 80 118 78 29 178 108 160 100 144 90 140 100 140 80
30 118 78 120 78 30 190 110 180 100 166 98 150 98 130 80
31 120 72 120 76 31 200 110 188 100 160 98 150 90 140 100
32 128 80 124 78 32 190 100 180 100 166 98 154 90 160 100
33 118 78 118 80 33 190 110 180 98 180 90 160 90 156 100
34 124 84 122 82 34 188 100 166 98 170 90 156 90 150 90
35 130 82 128 86 35 154 100 150 98 144 80 146 90 144 90
36 128 78 126 76 36 150 100 140 90 150 84 144 90 130 82
37 122 82 120 80 37 190 110 180 100 170 94 144 86 156 90
38 130 84 130 82 38 144 106 140 100 132 98 138 88 132 84
39 132 82 130 86 39 190 110 178 100 144 98 140 86 140 84
40 130 80 128 80 40 154 100 140 96 130 94 138 94 140 90
41 134 80 136 82 41 150 100 140 94 130 92 136 92 136 90
42 136 86 132 82 42 148 100 140 92 138 90 138 90 134 88
43 128 84 136 80 43 150 106 144 100 140 94 140 98 134 90
44 134 82 132 78 44 166 110 156 100 144 100 140 100 146 90
45 138 80 134 76 45 180 100 170 100 156 96 144 98 156 82
46 128 78 122 78 46 188 108 180 90 170 88 160 88 150 84
47 124 82 120 78 47 188 110 180 96 176 94 160 94 144 100
48 126 84 124 80 48 190 112 180 100 168 94 156 96 144 100
49 120 80 118 78 49 190 110 180 100 170 98 160 90 150 88
50 128 80 120 78 50 190 110 180 100 170 98 156 96 150 88
51 122 80 112 78 51 180 110 180 100 170 94 160 98 144 88
52 120 80 116 80 52 168 110 156 108 144 100 138 100 144 100
53 128 86 122 84 53 178 108 170 98 166 100 166 96 148 94
54 130 82 126 82 54 190 110 180 96 176 94 156 94 150 100
55 132 88 130 84 55 156 100 150 100 144 98 144 98 132 88
56 124 82 122 80 56 154 98 154 100 144 94 150 94 130 90
57 120 80 114 78 57 152 108 150 100 148 100 148 90 130 84
58 108 78 110 78 58 160 98 146 100 144 94 144 94 140 90
59 118 74 118 76 59 160 100 150 98 134 100 134 90 144 84
60 122 80 115 70 60 156 100 144 96 140 100 134 90 132 82
61 118 80 118 80 61 144 100 136 98 134 90 134 96 130 80
62 120 80 120 78 62 158 106 144 90 132 90 132 90 130 88
63 112 80 118 80 63 178 108 144 84 140 84 140 84 150 100
64 122 84 118 80 64 190 110 178 100 170 98 160 98 156 100
65 118 80 120 80 65 150 102 148 98 144 94 144 94 150 98
66 120 80 120 78 66 160 106 150 96 154 94 154 94 132 90
67 116 78 116 78 67 150 100 144 98 136 96 136 96 144 94
68 130 78 128 80 68 144 100 140 90 136 90 136 88 138 86
69 123 80 122 72 69 190 110 160 98 156 96 150 90 156 100
70 134 80 130 78 70 188 112 160 100 150 94 144 94 150 90
71 108 64 110 70 71 155 108 150 102 148 90 148 100 144 88
72 125 74 120 74 72 156 104 144 98 134 94 134 94 144 86
73 122 78 122 70 73 150 100 150 98 144 90 136 76 144 90
74 120 78 120 78 74 142 100 140 84 140 80 140 80 140 90
75 120 70 120 70 75 150 100 150 96 144 94 138 94 136 90
76 119 80 118 80 76 148 100 140 98 130 96 130 98 132 86
77 124 78 120 80 77 146 100 144 98 144 98 144 98 140 94
78 120 82 118 80 78 174 106 170 100 158 96 150 96 156 94
79 114 78 120 80 79 146 102 144 100 138 90 138 90 135 90
80 124 78 120 80 80 188 112 170 100 170 90 160 98 160 100
81 122 64 120 66 81 143 100 140 100 136 94 136 98 132 88
82 110 64 110 80 82 156 106 150 100 148 96 148 100 144 90
83 128 80 122 80 83 150 100 144 100 144 98 144 90 140 90
84 130 80 120 78 84 158 102 154 100 150 98 150 98 146 90
85 126 80 120 80 85 152 110 150 100 144 98 144 90 140 90
86 120 80 120 78 86 150 100 144 98 140 94 140 88 136 88
87 122 78 120 74 87 148 100 140 90 144 90 140 90 140 90
88 118 70 118 80 88 186 110 182 105 180 102 160 100 170 100
89 120 80 120 76 89 156 100 150 100 140 98 136 96 130 80
90 116 80 116 78 90 156 110 144 100 140 90 140 88 130 88
91 124 74 120 80 91 150 110 144 100 140 90 134 88 132 90
92 120 80 118 78 92 146 100 144 90 142 98 142 100 140 80
93 122 80 120 80 93 144 110 140 100 140 90 140 90 136 82
94 112 80 114 78 94 180 110 170 100 160 94 156 90 160 100
95 118 78 118 68 95 152 100 150 90 146 90 144 90 146 90
96 124 76 120 72 96 190 100 180 98 166 90 150 88 160 100
97 122 80 118 78 97 180 110 170 100 176 98 156 98 170 100
98 112 74 120 80 98 148 100 144 98 142 90 144 88 140 82
99 120 76 120 78 99 160 100 150 100 154 90 154 90 150 100
100 120 80 122 78 100 158 100 144 96 152 92 152 86 144 84

Table 3b Changes in blood glucose in DM patients treated with glibenclamide and DM patients treated with glibenclamide in combination with sesame oil blend.

Table 3b
Type 2 diabetes + Glibenclamide Type 2 diabetes + Glibenclamide + Sesame oil blend
0 days 30 days 60 days 0 days 30 days 60 days
S.No FBG PPG FBG PPG FBG PPG S.No FBG PPG FBG PPG FBG PPG
1 179 200 160 199 134 175 1 250 310 150 266 103 195
2 166 212 156 200 140 150 2 293 315 146 200 140 103
3 170 200 156 188 133 160 3 200 280 134 224 136 142
4 170 250 160 200 156 176 4 260 293 124 234 142 124
5 165 223 160 200 145 177 5 185 210 124 200 130 123
6 150 240 134 212 144 180 6 173 258 128 200 122 107
7 168 220 144 212 144 190 7 175 200 150 200 118 122
8 200 230 156 222 146 180 8 260 293 150 180 173 190
9 144 200 150 224 134 190 9 176 234 120 158 144 134
10 180 246 156 234 134 190 10 175 200 170 196 112 181
11 150 254 138 240 132 185 11 293 315 287 278 240 271
12 160 245 150 240 140 190 12 170 200 175 188 155 163
13 160 240 144 220 132 190 13 144 180 120 145 116 140
14 180 200 160 190 122 160 14 144 224 124 200 100 100
15 190 234 160 200 140 188 15 144 234 132 200 112 142
16 188 266 166 254 138 198 16 287 324 200 300 154 200
17 180 256 160 210 138 196 17 249 312 160 240 120 180
18 160 244 150 200 132 198 18 166 200 140 180 132 104
19 190 200 156 198 130 188 19 170 210 150 190 130 150
20 190 244 144 212 140 178 20 170 212 132 140 142 120
21 156 200 132 188 122 197 21 193 243 180 230 136 152
22 188 224 168 220 126 180 22 174 200 160 160 140 151
23 160 200 144 205 122 178 23 190 230 160 200 114 160
24 180 244 140 230 120 170 24 166 253 134 150 132 134
25 150 256 132 244 120 180 25 132 234 115 150 100 140
26 180 244 156 212 122 170 26 180 220 100 200 132 140
27 190 256 140 222 132 156 27 205 320 160 250 140 200
28 180 250 156 234 132 160 28 165 240 130 200 125 150
29 150 244 140 200 126 170 29 156 200 124 148 100 125
30 210 240 188 246 144 178 30 160 222 144 200 100 120
31 180 226 148 230 132 160 31 154 234 140 120 123 110
32 190 228 155 210 130 160 32 106 200 99 190 100 125
33 165 200 144 190 128 160 33 158 200 123 188 100 130
34 190 240 150 200 134 164 34 166 244 132 200 100 100
35 180 244 140 223 140 168 35 150 200 90 188 100 115
36 178 244 150 212 132 180 36 140 212 140 154 100 110
37 200 235 164 217 173 190 37 144 244 124 160 100 120
38 190 365 156 300 122 156 38 250 300 200 290 250 166
39 180 246 144 230 144 170 39 190 244 150 220 110 160
40 190 240 150 212 122 176 40 154 250 115 240 120 220
41 180 300 154 250 140 198 41 152 260 130 220 110 134
42 190 256 132 188 140 176 42 170 220 150 180 130 150
43 200 300 160 254 156 178 43 130 226 120 160 100 150
44 178 258 132 221 140 170 44 200 270 146 220 150 200
45 145 244 120 190 120 180 45 166 200 150 170 140 150
46 190 250 144 231 133 190 46 216 212 170 190 150 160
47 178 234 132 200 132 187 47 150 245 125 145 120 140
48 190 228 154 221 144 188 48 220 240 190 160 150 158
49 200 244 156 216 134 180 49 220 300 160 250 150 200
50 190 240 160 224 132 182 50 200 300 145 200 140 150
51 200 300 160 256 156 200 51 175 200 155 150 145 160
52 190 244 166 228 132 190 52 264 300 170 200 144 195
53 200 244 168 234 140 180 53 160 250 140 243 110 150
54 187 234 154 220 132 176 54 165 246 150 170 145 160
55 190 230 168 223 130 170 55 200 240 180 200 160 190
56 188 232 170 230 140 166 56 155 244 130 226 82 130
57 187 256 168 244 132 160 57 197 266 170 224 100 170
58 190 260 156 236 134 160 58 150 260 140 232 95 130
59 200 335 160 290 144 190 59 150 253 125 223 90 140
60 175 260 150 212 165 180 60 124 224 134 200 100 140
61 180 234 156 225 126 181 61 165 200 150 170 130 150
62 230 300 156 227 144 170 62 150 244 134 200 100 115
63 190 250 178 220 124 170 63 200 256 145 170 140 150
64 200 224 170 220 155 180 64 170 230 150 210 140 195
65 200 280 178 256 132 170 65 172 210 160 190 150 175
66 204 260 190 234 122 166 66 178 200 130 188 100 125
67 180 280 180 178 122 175 67 145 220 100 220 100 126
68 200 280 170 224 134 160 68 190 248 160 200 105 145
69 200 258 144 200 132 188 69 200 245 180 200 150 190
70 173 277 174 200 172 199 70 145 200 125 180 120 130
71 180 250 172 195 170 193 71 156 230 145 160 135 195
72 190 269 142 275 144 170 72 178 224 125 200 112 153
73 170 258 165 201 134 178 73 168 258 155 270 145 260
74 151 200 145 191 132 180 74 146 300 134 200 100 148
75 145 234 142 195 130 195 75 217 260 190 245 160 200
76 170 234 122 180 166 178 76 167 287 150 260 109 170
77 200 230 160 190 134 180 77 200 298 260 200 132 166
78 200 256 150 200 150 198 78 206 300 180 300 130 166
79 212 250 172 226 134 170 79 200 200 160 200 155 175
80 200 233 156 223 132 185 80 200 256 210 266 142 145
81 160 230 130 220 122 160 81 178 280 150 250 136 156
82 166 238 135 200 122 156 82 195 244 170 280 160 148
83 154 240 145 220 122 173 83 140 208 136 224 130 180
84 190 256 167 222 133 154 84 180 258 146 300 122 190
85 190 244 156 200 145 151 85 178 280 150 270 130 200
86 150 244 132 200 156 146 86 200 296 150 245 132 166
87 148 250 165 244 132 160 87 200 281 160 250 150 252
88 170 240 132 256 124 180 88 200 260 166 200 145 255
89 154 260 150 277 122 178 89 186 230 165 222 140 220
90 150 250 145 266 122 194 90 200 300 185 244 120 156
91 160 266 148 242 132 160 91 176 284 157 266 132 250
92 174 204 165 202 166 160 92 178 210 130 200 128 147
93 154 260 140 235 140 195 93 186 288 126 200 100 161
94 200 280 160 244 144 150 94 290 314 200 300 134 200
95 188 246 156 200 140 145 95 188 224 148 208 140 190
96 200 244 160 194 144 140 96 249 300 200 290 122 200
97 190 250 138 224 135 160 97 192 247 170 220 155 205
98 190 256 145 232 146 166 98 200 256 160 200 112 146
99 200 246 144 202 144 170 99 190 290 160 250 112 200
100 200 254 148 206 144 190 100 180 230 140 250 122 180

Table 3c describes Changes in HbA1C in normoglycemic subjects and DM patients treated with sesame oil blend, DM patients treated with glibenclamide and DM patients treated with glibenclamide in combination with sesame oil blend.
Table 3c
Normal subjects +Sesame oil blend Type 2 diabetes + Sesame oil blend Type 2 diabetes + Glibenclamide Type 2 diabetes + Glibenclamide + Sesame oil blend
S. No 0 day 60 days S. No 0 day 60 days S. No 0 day 60 days S. No 0 day 60 days
1 4.2 4.3 1 6.6 6.2 1 7.2 5.9 1 7.3 5
2 4.8 4.8 2 6.1 5.8 2 6 6 2 8.8 6
3 4.7 4.6 3 6.7 6.2 3 5 5.1 3 7.2 4.9
4 4.6 4.5 4 5.8 5.4 4 6.8 5.3 4 8.3 5
5 5.1 5.2 5 6.2 6 5 6.6 5.7 5 6 5.2
6 5 5 6 6 6 6 6.2 5.9 6 6.8 5.6
7 3.8 3.9 7 6 6 7 6.6 5.3 7 6.8 5.8
8 4.9 4.8 8 6 5.6 8 7.1 5.5 8 8.3 6.8
9 5.2 5.1 9 7.2 7 9 6.8 5.1 9 5.8 5.25
10 5.1 5.2 10 6 6 10 6 4.9 10 7.2 6.9
11 5.1 4.9 11 7 6 11 7.7 5 11 8.8 8.1
12 5.4 5.3 12 6 5.3 12 5.6 5.3 12 7.2 6.7
13 6.4 6.3 13 6 5.2 13 5 5.6 13 6.1 5.9
14 6.2 6.1 14 6 5.3 14 5.7 5.3 14 5.6 5.1
15 5.2 5.1 15 7 5.5 15 6.6 6 15 5.6 4.4
16 4.9 4.9 16 6 5.6 16 5.5 6 16 8.4 7.5
17 4.4 4.4 17 6 6 17 6 5 17 7.2 5.6
18 5.2 5.2 18 6 5.6 18 6 5.8 18 6.1 4.5
19 5.6 5.5 19 7 5.5 19 5.4 5 19 7.1 5
20 5.2 5.1 20 6 5.6 20 5.6 5.2 20 6.3 4.6
21 5.2 5.2 21 5.9 5.8 21 6.3 5 21 6.6 6.4
22 4.8 4.8 22 6 5.8 22 6 6 22 6.3 5.8
23 5.4 5.3 23 6 5.7 23 5.6 6 23 6.6 6.3
24 5.3 5.3 24 7 5.8 24 6.1 5.9 24 6 4.6
25 5.1 5.1 25 6.1 6 25 6 5 25 7.2 5.5
26 4.9 4.9 26 6.2 5.9 26 7.2 5.2 26 6 4.5
27 4.9 4.9 27 6.3 6.2 27 8.8 7 27 8 6.7
28 4.8 4.7 28 6.1 6.1 28 7.5 4.9 28 7.9 6.2
29 5.4 5.3 29 6.3 6.2 29 6.7 7.2 29 5.7 4.9
30 5.3 5.3 30 6.1 6.1 30 7.8 5.5 30 5.8 5.3
31 5.2 5.2 31 6 5.6 31 7.3 6 31 5.4 5.3
32 5.3 5.3 32 6 5.7 32 6 6 32 5.9 5.7
33 5.4 5.4 33 7 6 33 6.6 6.3 33 5.3 5.2
34 5.6 5.5 34 7 5.5 34 6.8 6.1 34 5.4 5.2
35 5.6 5.6 35 7 8 35 5.6 5.2 35 6.4 5.5
36 5.2 5.2 36 7.8 7.7 36 7.6 7 36 5.2 4.5
37 5.3 5.2 37 7.6 7.5 37 6.9 6.8 37 5.9 4.6
38 5.4 5.3 38 7.4 7.3 38 7.7 7 38 8.2 7.7
39 4.9 4.9 39 7.3 7.2 39 6 5.3 39 7.8 4
40 4.8 4.8 40 7.6 7.6 40 6 8.3 40 5.6 5.2
41 5 5.1 41 7.7 7 41 7.8 6 41 7.7 4
42 5.2 5.2 42 6.6 7 42 8.3 6 42 7.5 6.4
43 5.4 5.3 43 6.5 6.3 43 8 7.2 43 5.6 5.1
44 5.3 5.2 44 8.1 7.9 44 6.6 4.8 44 7.8 6.1
45 4.9 4.8 45 9 7 45 6.4 5.2 45 7.8 6.8
46 4.8 4.9 46 7 7 46 6 4.9 46 7.9 5.8
47 5.5 5.5 47 9.8 6 47 6.6 4.5 47 5.8 4
48 5.4 5.4 48 6.6 6.5 48 6 5 48 7.8 5.8
49 5.3 5.3 49 7.8 7.7 49 8.4 6 49 8 6
50 5.7 5.6 50 9.8 8 50 6 5 50 6.5 5.8
51 5.6 5.5 51 8 9 51 7.8 6.1 51 7.8 5.8
52 5.4 5.3 52 9.8 6 52 6 5.5 52 9 5
53 4.6 4.5 53 8 7.8 53 8.8 7 53 6.2 5
54 4.5 4.5 54 9.7 7.9 54 7 6.4 54 6.6 6
55 5.1 5.2 55 9 7 55 6.6 6 55 9 6.6
56 4.8 4.7 56 7 7 56 7 6 56 6.3 4.8
57 4.6 4.6 57 7 8 57 7 5.3 57 8 6.6
58 4.5 4.4 58 8.2 8.1 58 9.8 5.4 58 5.8 4
59 4.6 4.5 59 8.1 7.9 59 7 7 59 6.5 4
60 4.7 4.7 60 8.2 7 60 6.6 7.5 60 5.4 5.2
61 4.8 4.7 61 8.4 6 61 7 6 61 6.7 4
62 5.3 5.4 62 9.9 8 62 7.9 7.3 62 6 5.1
63 5.4 5.4 63 9.3 7.8 63 6.8 6.5 63 6.9 5.7
64 5.5 5.4 64 9.3 9 64 7.5 7.6 64 7.6 5.2
65 5.4 5.3 65 9.4 9 65 10.2 8 65 8.5 5.8
66 5.6 5.5 66 8 9 66 10.4 8 66 5.6 5.2
67 5.6 5.6 67 7 7 67 9.9 9.8 67 5.7 4.9
68 4.3 4.3 68 9.7 8 68 9.8 9.7 68 5.6 5.4
69 4.4 4.4 69 9.8 6.8 69 9.6 9.5 69 9.8 5.9
70 4.2 4.1 70 7.6 7 70 9.8 7 70 5.8 4
71 5 4.9 71 9.4 8 71 9.9 9.7 71 6.6 5.7
72 5.1 5.1 72 7 8 72 6.8 6.8 72 6.1 5.3
73 5.4 5.3 73 9.8 8 73 8.3 7 73 7 5.6
74 5.3 5.3 74 6 5.7 74 8.1 7 74 6 5.3
75 4.5 4.5 75 6.4 5 75 8 7.9 75 9.8 6.2
76 4.6 4.5 76 6.3 5.8 76 9.1 8 76 5.9 5.2
77 4.4 4.4 77 7.4 6 77 8.9 7 77 8.9 6
78 4.8 4.7 78 7.9 6 78 8.8 8.7 78 9 6.6
79 4.2 4.2 79 8 6 79 9.3 7 79 9.7 6.3
80 4.9 4.8 80 7 6 80 9.1 8 80 10 5.6
81 5.2 5.2 81 8 6 81 7.3 7.4 81 5.8 5.2
82 5.6 5.5 82 6 6 82 7.4 7.2 82 8 6.5
83 5.9 5.8 83 7 5 83 7.7 6 83 5.7 5.3
84 5.6 5.5 84 7 6 84 6.9 6.8 84 9 5
85 5.7 5.6 85 8 6 85 7.1 6 85 7.9 5
86 5.8 5.7 86 8 6 86 7.2 6 86 9.9 6
87 5.7 5.6 87 6 5.9 87 7.1 6 87 8.7 5.8
88 5 5 88 9 6.8 88 7.9 6 88 9.5 6.5
89 4.9 4.9 89 8 6 89 7.5 7.4 89 8.8 6.6
90 4.9 4.8 90 8 6.6 90 8.2 8 90 9.7 7.2
91 4.6 4.6 91 7 5.8 91 8.4 7 91 8.6 5.8
92 4.5 4.5 92 7 6 92 8.7 7 92 7 5.3
93 4.4 4.4 93 8 5.8 93 8.1 8.2 93 6 5.4
94 4.7 4.6 94 6 5 94 6.7 6.7 94 9.8 6
95 5.1 5.1 95 7 6 95 6.9 6.9 95 6.1 5.7
96 4.9 4.9 96 6 5.6 96 6.7 6.6 96 9.8 7.9
97 5.3 5.3 97 8.4 6 97 7.8 7.6 97 9.7 4
98 5.5 5.4 98 6 5 98 6.7 6.7 98 8 5.7
99 5.6 5.5 99 7 6 99 6.6 6.7 99 9.7 5.8
100 5.2 5.2 100 8.9 7 100 7.3 7 100 7 5.2

Results: As shown in Table 2 ,3 and Figure 3(b)(i),3(b)(ii), SBP, DBP and MAP levels were significantly lowered (p<0.001) in hypertensive groups given sesame oil blend alone or nifedipine alone at days 15, 30, 45 and 60 as compared to the baseline values, whereas sesame oil blend with nifedipine substituted group patients showed significantly remarkable reduction (p<0.001) in SBP, DBP and MAP levels at days 15, 30, 45 and 60 compared to the baseline values. The blood pressure reduction in sesame oil blend with nifedipine group was the greatest as compared to sesame oil blend alone or nifedipine alone treated groups, and the blood pressure values were very close to normal in this group at the end of the study.

As shown in Table 2 ,3 and Figure 3(b)(i),3(b)(ii), the hypertensive patients showed significantly higher levels of TC, LDL-C, non-HDL-C and TG values, and low levels of HDL-C as compared to normotensives at baseline. TC, LDL-C, non-HDL-C and TG levels were significantly lower (p<0.001) in hypertensives with sesame oil blend alone or in combination groups, whereas nifedipine alone group didn’t show any significant alterations at day 60 as compared to baseline levels. Moreover, HDL-C levels significantly increased only in sesame oil blend alone or in combination in hypertensive groups at the end of 60th day. In the normotensives with sesame oil blend group, a slight change in TC, LDL-C and HDL-C values was noted, which was however statistically non-significant. Shown in figure 2 are the scatter plots of the absolute changes in SBP, DBP and MAP, and LDL-C, HDL-C, TG and non HDL-C. The changes in blood pressure and lipid profile were related to the respective baseline levels of the hypertensives and normotensives.

We demonstrated for the first time, cooking with a combination of 20% un-refined cold pressed antioxidant lignans rich sesame oil and 80% physically refined ?-oryzanol rich rice bran oil in a variety of ways worked nearly as well as a commonly prescribed high blood pressure medication, and that the use of the oil blend with medication yielded even more impressive results. Healthier fatty acids and antioxidants, such as sesamin, sesamol, sesamolin and oryzanol, in sesame oil blend could be possible candidates responsible for the results. Additionally, it may reduce heart disease risk in other ways, including being a substitute for less healthy oils and fats in the diet.

While comparing the tables and figures, the present system is proved to be superior over all the existing oils and oil blends available.

While various embodiments of the present invention have been described above, it should be understood that they have been presented by way of example only, and not limitation. It will be understood by those skilled in the relevant art that various changes in form and details may be made therein without departing from the spirit and scope of the invention.

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