DESCRIPTION:
The following specification particularly describes the invention and the manner in which it is
to be performed:
TITLE: FOOD SUPPLEMENT FORMULATION FOR DL^ETICS
FIELD OF INVENTION:
This invention relates to a food supplement formulation for diabetics and in particular to a
food supplements formulation containing phytonutrients form the herbs whose combination
usefiil in relation to, but not limited to nutrition but also provides right amounts of all the
vitamins, minerals and antioxidants which are critical in the management of diabetes.
BACKGROUND AND PRIOR ART:
Maintaining a healthy diet is essential for good health. Individuals are encouraged to control
calories, to avoid fets, to increase fiber intake, to take vitamins as supplements and to eat
cruciferous vegetables and fruits for a balanced diet. Despite the substantial advertising of the
advantages of certain foods, control of calories and the detrimental eflects of ignoring the
advice, the fact remains that a substantial portion of the population has an unbalanced diet
and is susceptible to various diseases. Toady diabetes has become an epidemic; more than
400 million are suflFering worldwide. India is home to at least 50 million diabetics and an
equal number don't even know that they are suffering fiom it. To manage diabetes people are
resorting to Pharma intervention, Ayurveda, naturopathy, homeopathy and food supplements.
As diabetes is a lifestyle disease it requires lifestyle modification which consists of right
exercise, right eating habits, supplementation of vitamins, minerals and antioxidants, healing
herbs, stress management, blood sugar monitoring, motivation and healthy joints and
muscles apart from oral hypoglycemics and in advanced cases injectable forms like insulin.
Pharma management of DM is revolving around the drugs that lower the BS levels using
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sulphonylureas, biguanides, thiazolidinediones and alpha glucx)sidase inhibitors:
primarily through 3 ways:
1. Agents that increase the amount of insulin secreted by the pancreas
2. Agents that increase the sensitivity of target organs to insulin
3. Agents that decrease the rate at which glucose is absorbed fiom the gastrointestinal
tract.
Other injectable drugs are also used like insulin, exenetide and pramlintide.
Homeopathy has very few options for diabetes, which are limited to alcoholic drops of single
herbs like, Gymnema Sylvestre. There are a lot of Ayurvedic products in the market, but
there are a lot of issues with the processing and manufacturing of the products, besides a lack
of the right combination of herbs.
Recently, it has been suggested that certain amino acids, when used as supplements to a
normal diet in relatively large doses. The doses are suflSciently large that one would need to
take a large number of pills or a large volume of powder to achieve the desired therapeutic
dosage level. Unfortunately, amino acids have an undesirable flavor and can readily react
with a variety of other chemicals found in foods, particularly when combined at elevated
temperatures.
Natural compounds, including herbal formulations, can provide a healthy supplement to the
daily human diet. Certain natural compounds are use&l for proper fimctioning of the human
body and for assuring high energy levels, but are not contained in appropriate quantities in
the daily diets of many people. U.S. Pat. No. 6,228,368 discloses a food supplement
formulation containing a mbcture of fatty acids, including flaxseed oil and borage seed oil.
In literature, the importance of Sattu as a heat reliever is provided. The sattu is generally
extracted from barley, gram or wheat and is easily available. Rajasthan State Agricultural
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Mariceting Board is also highlighting the importance of barley the major portion of this crop
is consumed by people, either as flour (pure or mixed with that of wheat or gram) for chapati
making or as parched grain to make sattu.
Ram dev has suggested the use of a floor composition comprising whole wheat (gehu), Water
Caltrope (singada) ,Gram (chana), Barley (jowar), Amaranth (chowlai),Soya, Millet
(bajraXMaize (makka), Oats (jou). There are many patents applications on food supplement
formulation using diflFerent ingredients like Publication No 20060257530 relates to a cereal
bran fortified with an effective amount of select additives such as vitamins, minerals, and
essential dietary fats to promote digestive health. Publication No Qvll01347241 relates to
health food that comprises 40-70wt% of wheat bran, 10-45wt% of medicinal food, and
5-30wt% of agricultural and sideline products.
There are hardly any good supplements for diabetes in the market, if they are present they
only contain some vitamins, minerals and antioxidants but do not contain the herbs with it(in
the Indian Market). Ayurvedic products do not contain the above mentioned vitamins,
minerals and antioxidants.
As the market for supplements is not well regularized, most of the manufacturers do not put
the right amount of vitamins, minerals and antioxidants or sometimes of cheap quality, so as
to increase profits.
Accordingly, thus there is a need of an food supplement formulation for diabetic, having a
proper combination extract of all the phytonutrients form the given herbs in right proportion
with all the vitamins, minerals and antioxidants to provide optimum nutrition, health
protective, promotive and disease preventive benefits for diabetic patients.
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OBJECTS OF THE INVENTION:
The principal object of the present invention is to provide a food supplement formulation for
diabetics, having a proper combination extract of all the phytonutrients form the given herbs
in right proportion with all the vitamins, minerals and antioxidants to provide optimum
nutrition, health protective, promotive and disease preventive benefits for diabetic patients.
Another objective is to provide a food supplement containing all the essential vitamins,
minerals and antioxidants which are needed critically for a diabetic and which are deficient in
most of the cases.
Another objective is to develop a food supplement containing the most important herbs
which are helpful for a diabetic and help the pancreas to go through a healing process,
sensitize the insulin and reduce the production so that the pancreas can recover.
Still another object of the invention is to provide a food supplement formulation that has
good stability.
STATEMENT OF INVENTION
The present invention relates to a food supplement formulation, having a proper combination
extract of all the phytonutrients form the given herbs in right proportion with all the vitamins,
minerals and antioxidants to provide optimum nutrition, health protective, promotive and
disease preventive benefits for diabetic patients.
DETAILED DESCRIPTION OF THE INVENTION
Accordingly, the present invention provides a herbal health protective, promotive and disease
preventive composition(s) useful as food supplement to the general health of people having
diabetics with optimum nutrients and also help to control the blood sugar level, wherein the
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said formulation(s) comprising herbs Gymnema Sylvestre ranging fix)m 20- 40% by
wt., Momordica Charantia ranging from 10 - 25% by wt., Cinnamomum Zeylicum from
7-18% by wt., Lagerstroemia Speciosa from • 7- 18% by wL, Trigonella Foenum
Graecumfrom 7-18% by wt, Syzygium Cuminifrom 5- 15% by wt., Pterocarpus
Marsupium from 5-15% by wt, Piper Longum from 2- 8% by wt., Azadirachta Indica from
2 - 8% by wt., Curcuma Longa from 2- 8% by wt, Ocimum Sanctum from 2 - 7% by
wt., Coccinia Indica from 2 - 7% by wt. Zingiber Ofiicinale from 2 - 7% by wt., Tinospora
Cordifolia from 2 - 7% by wt., Myristica Fragransfrom 2 - 7% by wt.„Emblica
Officinalis from 2 - 7% by wt., Cassia Fistula from 2 - 7% by wt., Salacia reticulate from 1 -
3% by wt, Moringa Oleiferafrom 1- 3% by wt, Commiphora Mukulfrom 1- 3% by
wt., Lawsonia Inermis from 1- 3% by wt., Alpha lipoic acid- 5-15% wt Lutein 0.5-
2% by wt, Zeaxanthin 0.2-1% by wt, Axtaxanthin 0.2-2% by wt.
Gymnema Sylvestre: It is called 'Gumnar' in Hindi, which literally means "Destroyer of
Sugar". It has been used to support healthy glucose metabolism by mediation of insulin
release and activity and enhancement of healthy pancreatic function. In addition to active
saponin ingredients called gymnemic acids, the herb contains a number of other saponins,
anthraquinones and flavonoid compounds including kaempferol and quercetin. Gymnemic
acid mimics glucose molecules, the glucose-like molecules in the gymnemic acid fill the
receptor locations in the absorptive extemal layers of the intestine, thereby preventing the
intestine from absorbing the sugar molecules. This is the only compound that has shown the
ability to lessen indicators of diabetes by directly repairing/regenerating the pancreas cells
responsible for producing insulin.
Momordica Charantia: Active constituents in bitter melon include glycosides, saponins,
alkaloids, fixed oils, triterpenes, proteins and steroids. The hypoglycemic constituents are a
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mixture of steroidal saponins known ascharantins, insulin-like peptides and alkaloids. TTiese
constituents are concentrated in the finits which have also been shown to have the most
pronounced hypoglycemic activity compared to other plantparts. Several other
phytochemicals including momorcharins, momordenol, momordicins,
cucurbitins,cucurbitacins have been isolated ik)m the bitter melon. It has a very good
hypoglycemic effect. The actions of momordica charantia include enhancement of beta cells,
Insulin promoting or mimetic Increased GLUT4 transporter protein of muscles. Increased
glucose utilization in liver and muscle tissues, Inhibition of glucose-6-phosphatas and
fructose-1, 6-bisphosphatase in the live rand stimulation of red-cell and hepatic
glucose-6-phosphate dehydrogenase Activities, Inhibition of glucose transport at the brush
border of the small intestine, Restoration of depressed enzymes activity in the liver
responsible for carbohydrate metabolism (including hexokinase, glucoskinase,
phosphofructDkinase).These data suggest that the mechanism of action of Momordica
Charantia could be partly attributed to increased glucose utilization in the liver rather than an
insulin secretion effect.
Cinnamomum Zeylicum: TTie primary chemical constituents of this aromatic spice include
cinnamaldehyde, gum, tannin, mannitol, coumarins and essential oils (aldehydes, eugenol,
pinene). The active ingredient in cinnamon turned out to be a water-soluble polyphenol
compound called MHCP. In test tube experiments, MHCP mimics insulin, activates its
receptor, and works synergistically with insulin in cells.
Lagerstroemia Speciosa: A plant native to Philippines, popularly known as the insulin plant,
it mimics insulin in the body thereby causing a reduction in the endogenous insulin
production. Its ability to lower blood sugar is attributed to its corosolic acid, a triterpenoid
glycoside, believed to facilitate glucose-transport into cells.
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Trigonella Foenum Graecum: The active ingredients are alkatoid teigoielline, and s^xdns
wiiidi presartlhe Hypogtycanic effids of fenugredi seeds. Studies repeated hypoglyconic eflects of
fenugreek seeds in type land type 2 diabdics. It was also danaistrated in sane studies that fenugtedc
seeds delayed ^stric onpfying and caused inhibition of glucose ttan^xxt as the seeds contain 50%
pectin te fixms a colfoid su^joisicxi wtei hydrated, v\4iidi can decrease rate of ^stric onptying and
slow carbohydrate absorptim. A study has recently shown feiugreek has a pctective effect oa dhanol
toxicity, wWdi may need fijriher studies in Inl^d belts of M a wtee akxtolism ard d i a t^
in hand.. It is known that hydroj^isolojcine amino acid ©dracted fiom feiugteek seeds inaease
glucose-induced insulin release through direct effect ai isolated islet of Langahans ficm both rats and
humana The presort study shovv« also that Imugjeek seeds deaease smmi triglycaide levels and have
significarit effect cm IJDL cr HDL ctolestm)! wtei consumed at Hgha-doses. The trigiycoide low^^
effect may be due to the pectin component that absc»bs bile adds.
Syzygium CXimini:The active ingredients in jamun include alkaloids, amino acids, flavonoids,
glycosides, phytosterols, saponins, steroids, tannins and triterpenoids. Fenugreek also has an
alpha glucosidase inhibitory effect, which results in the desired hypoglycemic effect.
Pterocarpus Marsupium: The active ingredients in vijaysaar are flavanoids, others being
liquiritigenin, isoloquiritigenin, marsupsin, pterosupin, and pterostilbene (3 important
phenolic constituents) which exert the hypoglycemic effect.
Piper Longum: The active ingredients in pippli are triterpenes and beta- sitosterol which exert
anti-hyperglycemic, anti-lipidperoxidative effects and reduces the oxidative stress associated
with diabetic complications.
Azadirachta Indica: The active ingredients in neem are tannins, steroids, saponins and
polyphenols. Neem exerts significant hypoglycemic effect.
Curcuma Longa: The active ingredients in haldi are curcumins, which are polyphenols that
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exert anti- inflammatory effect and are very strong antioxidants. The PPAR-g active
compounds of turmeric, curcumin, demethoxycurcumin, bisdemethoxycurcumin , and
ar-turmerone, are assumed to improve insulin resistance and ameliorate type 2 diabetes
mellitus by the same biological mechanism as the thiazolidinedione derivatives.
Ocimum Sanctum: The active ingredients in tulsi are phenolic compound Tannins,
Flavanoids, glycosides, Steroids, Amino acids and Saponins. Tulsi is an adaptogen and an
immunomodulator; it exerts anti-hyperglycemic, anti-lipidemic and anti-inflammatory
effects.
Coccinia Indica: The active ingredients in kundru are P-sitosterol and betulin. It has
anti-oxidative and anti-hyperglycemic effects.
Zingiber Officinale: Ginger possesses anti-hyperglycemic, anti-lipidemic and
anti-inflammatory effects. Additionally, raw ginger is effective in reversing the diabetic
proteinuria observed in the diabetic rats.
In the current scenario the soil; which used to provide the required minerals and the food that
used to provide different vitamins are depleted raising the question about supplementation.
The various vitamins, minerals and anti-oxidants are not only essential but critical in the
glucose metabolism hence in the management of DM.
Chromium: Helps insulin to attach at the receptor site, it is the most critical mineral in the
management of diabetes; the people who are deficient in chromium would have a veiy
chance of developing insulin resistance and therefore diabetes.
Vanadium: Improves glucose metabolism and mimics insulin, thereby reduces the insulin
release and helps control BS levels.
Zinc: Enhances glucose movement is stored in high quantities in beta cells and plays a very
important role in the production of insulin.
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Alpha Lipoic Acid: One of the strongest antioxidants available, it improves insulin
sensitivity and is very helpfUl in Peripheral Neuropathy. It helps in glucose metabolism and
helps bring down the BS levels.
Biotin: Improves glucose metabolism and is helpful in Peripheral Neuropathy.
Methylcobalamin: Is critical for the nervous system and is very helpful in the prevention and
management of Diabetic Neuropathy.
Benfothiamine: Benfolhiamine is extremely beneficial in Diabetic Retinopathy and
Peripheral Neuropathy. This fat soluble form of thiamine plays a very important role in the
glucose metabolism. With the regular usage of Benfothiamine sensation can be restored in
diabetic peripheral neuropathy.
Vitamin D3: Plays a very important role in glucose metabolism. Earlier considered a vitamin,
now it is considered a hormone, which plays very important role in controlling BS levels.
Selenium: Is an essential mineral for glucose metabolism and critically supports the thyroid
fijnction and the metabolism.
Folic acid: is essential in the reduction of Homocysteine- a byproduct of oxidation.
Lutein: This antioxidant is very helpful in Diabetic retinopathy and over all improves
eyesight.
Pyridoxine: Vitamin B6 is essential in the reduction of Homocysteine- a byproduct of
oxidation.
Astaxanthin: One of the strongest known antioxidants which is critical for retinal health and
helps not only in prevention but the reversal of diabetic retinopathy.
Extract all the right phytonutrients fixjm the herbs both polar and non-polar by not the
traditional solvent based (for oils and oleoresins) but with supercrticicalCQz extraction and
(not water soluble filtration), but with spray drying at the right temperature(under vacuum) so
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that the phytonutrients stay intact and there is no fiber in the extract. Then blend the
phytonutrients in the right proportion Gymnema Sylvestre ranging fix)m 20- 40% by
wt., Momordica Charantia ranging fix)m 10 - 25% by wt., Cinnamomum Zeylicum fixam
7-18% by wt, Lagerstroemia Speciosa from 7- 18% by wL, Trigonella Foenum
Graecumfk)m 7-18% by wL, Syzygium Cuminiirom 5- 15% by wt., Pterocarpus
Marsupium fixjm 5-15% by wt.. Piper Longum fix)m 2- 8% by wt., Azadirachta Indica fi-om
2 - 8% by wt.. Curcuma Longa fi-om 2- 8% by wL, Ocimum Sanctum fi-om 2 - 7% by
wt., Coccinia Indica fi-om 2 - 7% by wt.. Zingiber Officinale from 2 - 7% by wt., Tinospora
Cordifolia fiom 2 - 7% by wt., Myristica Fragransfix)m 2 - 7% by wt.„Emblica
Officinalis fiom 2 T 7% by wt.. Cassia Fistula fix)m 2 - 7% by wt., Salacia reticulate fix)m 1 -
3% by wt., Moringa OleiferafixDm 1- 3% by wt.. Commiphora Mukulfixjm 1- 3% by
wt., Lawsonia Inermis fix)m 1 - 3% by wt. Alpha lipoic acid- 5-15% wt, Lutein 0.5- 2% by wt,
Zeaxanthin 0.2-1% by wt, Axtaxanthin 0.2-2% by wt. so that they give a synergistic effect.
When the two types of extracts are mixed they give all the phytonutrients in the herbs.
Besides this vitamins, minerals and antioxidants have been blended them in the supplement.
The advantage of this process is that all the phytonutrients are intact and the best of nature is
utilized. It has all the nutrients which are not there in the oral hypoglycemics and it provides
all the requirements which are expected fit)m a diabetes supplement, so the patients don't
need to take anything apart fiom their oral hypoglycemics or the insulin they are injecting.
Over a period after taking this supplement, they can reduce the dosage of their oral
hypoglycemics and insulin.
By combining both the extracts it makes a nice granule which is perfect for filling in hard
gelatin capsules, soft gels and making of tablets or any other form.
The herbs are taken through processes, where the herbs which have mostly water soluble
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phytonutrients go through the extraction with spray drying and the ones which contain both
polar and non-polar first go through the supercritical CO2 extraction and then through the
spray drying, the processes are mentioned briefly below:
The Extraction process b^ins with the carefiil selection of raw mafiaials. The raw matoials once
received are first subjected tD saniple in^3ectiai to detaniine the qua% in tarns of physical appeaianc^
contamination of any extraneous material etc. Once the raw material is accepted the same is takai fo
pulverizing. Yoc mataials which are heat senative the puh'Qizing is earned out at extremely fow
tempeiatures. The pulvaized mataial is tei stcaed in plastic bins whidi are 1 ^ closed until they are
taken fix the extractioi process.
The sipooitical extraction process ccmprises of flowing the required quantity of CO2 at tiie deared
process cotxliticxis. The ^ i c a l process caiditiais are pressures in the range of 80 to 400 bar and
temperatures in the range of 20 to 80 d ^ C. These process concMons are standardized based on tiie
extensive research and analysis of the extracts foe the required active ingredients and the ccxxxaitraticxi
within t e total extract
The extract usuaUy ccMitains sane amount of water whidi is coextracted This wata is carefully
using gravity column of centrifliging. The finished extract is thai subjeded to piiysical examination and
tei pacted in air ti^ cartainers vvhi± are typicaUy plastic jars a-aluminium botfles.
Aflffte canplete exlracticn of the hab tiie extractors are dqxessurized and the exhausted raw material
is taken out The fiesh material is thai rediarged and the process is repealed.
The extracted raw malaid is rKDw compldefy devoid of nai polar substarices and is subjected to wataexlractiai
Hae flie hab powder is mixed with daninaalised and distilled wafe and the mixture is
stirred arri kept in flie reactor fix few hours. The pnxess taripoature is carefi% controlled to ensure that
the themial daniage to the active molecules is kq3t to a bare rninimum. After the required batdi time the
mixture is filfaed in a pessure filta- to separate tiie insoluble heib powda- and solutiai. The solutiai is
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further micro filtered and thm takm for sptay drying process.
In Ihe spay dtyer Ihe solution is ^xayed in a fixm of fine mist and the wala" is instantly ev^xxated
vvWdi gives rise to fine powder v^iidi iqxesents aU tie water soluble active ingrediei^
powder.
The dried watH-exhact is then padffid in tiie inat padagbg.
SPECIFIC COMBINAnONS
To prepare formulation(s) comprising herbs Gymnema Sylvestre, Momordica Charantia,
Pterocarpus Marsupium, Trigonella Foenum Graecum, Cinnamomom Zeylicum, Syzgium
Cumini, Alpha Lipoic Acid, Boifothiamine, Tinospora Cordifolia, Coccinia Indica, Lutein,
Myristica Fragrans, Azadirachta Indica, Zingiber Officinalae, Piper Longum, Ocimum
Sanctum, Emblica Officinalis, Cassia Fistula, Lagerstroemia Speciosa, Curcuma
Longa, Astaxanthin, Moringa Oleifera, Commiphora Mukul, Lawsonia Inermis,
Zeaxanthin with Minerals(Zinc, Chromium, Vanadium, Selenium) and vitamins(B3, B6,
B12, Biotin, Folic acid and D3).
.The whole process is already mentioned above. The ingredient is filled in '00' size capsules
and the fill it between 675-725mg per hard gelatin capsule and lOOOmg in soft gelatin
capsules. There could be other options like tablets, siachets or pouches.
There would be different combination which would be in the range of herbs i.e. anything
between tiie higher and lower range mentioned next to the herb.
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Nutritional [nformation ' Per Serving (Pfcr g)
(Approximate \Mues) (Nd: Content)
faergy 6.3Kcal
Carbohydrate 12g
Protein OJg
Fat ai2g
Essential Vitamins %W/W
Vitamin B3 lOtr^ .0071
Vitamin B6 Img .00071
Vitamin B12 Im^ .000000007
Biotin 500mcg .00035
Folic Acid O.lSmg .00010
Vitamin D3 2001U .0000035
Essential lyfnierals
Zirc Itog .0071
ChncMnium 200mcg .00014
Vanadium ; 4mg .0028
"~ I Selenium | 70nK:g | .00005
GfyconicSuipxtCanplex 1400mg
(PioprietaiyBlaidofBotanicals and Antioxidants)
Two capsules of contain:
Numerous modifications and adaptations of the system of the present invention will be
apparent to those skilled in tiie art, and thus it is intended by the appended claims to cover all
such modifications and adaptations which fall within the true spirit and scope of this
invention.
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lAVe CLAIM:
1. A food supplement fomiulation fw diabetics, wherein the said formulation comprising: (a) herbs
Gymnema Sylveslre ranging fiom 20- 40% by wL, Momordica Charantia ranging fix)m 10 -
25% by wt., Cinnamomum Zeylicum from 7-18% by wt., Lagerstroemia Speciosafrom 7-18%
by wt, Trigonella Foenum Graecumfrom 7-18% by wL, Sy^gium Cuminifix)m 5- 15% by
wL, Pterocarpus Marsupium frcxn 5-15% by wt, Pipo- Longum from 2- 8% by wL, Azadirachta
Indica from 2 - 8% by wt. Curcuma Long3 from 2- 8% by wt, Ocimum Sanctum fix)m 2 - 7% by
wt, Coccinia Indica from 2 - 7% by wt, Zingiber OfiBcinale from 2 - 7% by wt, Tinospora
Cordifolia from 2 - 7% by wt, Myristica Fragrans fix)m 2 - 7% by wt„ Emblica Officinalis from 2
- 7% by wt. Cassia Fistula from 2 - 7% by wt, Salacia reticulate from 1 - 3% by wt, Moringa
Oleifera from 1 - 3% by wt., Commiphora Mukul from 1 - 3% by wt., Lawsonia Inermis from 1 -
3% by wt., (b) Antioxidants Alpha lipoic acid- 5-15% wt, Lutein 0.5- 2% by wt, Zeaxanthin
02-1% by wt, Axtaxanthin 02-2% by wt
2. A f(»mulation as claimed in claim 1, wherein the herbs are taken through the supmaitical CO2
extraction and then through the spray drying and then blended with the vitamins, minerals and
antioxidants.
3. A formulation as claimed in claim 2, wherein spray drying at the right temperature (under vacuum)
so that the phytonutrients stay intact and there is no fiber in the extract
4. A fcxmulation as claimed in claim 3, wherein typkdprocessccxiditionsOCEextracfionarepressuresin
teran^of80to400berandtBnperatutesinttierangeof20to80degC.
Date: 28* October, 2011
TARUNJAIN
(Patent Agent)
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