Field of invention:
Present invention relates to a composition for lowering glycemic index of foods and
beverages. More particularly, invention relates to a composition for lowering glycemic
index of foods and beverages prepared by water based extraction of herbs. Also present
invention relates to a process for preparation of a composition for lowering glycemic index
of foods and beverages.
Background of Invention:
The United Nations has recently declared that chronic non-communicable diseases such as
heart disease, cancer and diabetes pose a greater health burden worldwide than do
infectious diseases contributing to 35 million deaths annually. Adoption of Western diet,
dominated by highly processed food and refined sugar has witnessed rising rates of obesity
and related diseases. Hence, the prevalence of diabetes, obesity, and subsequent cardiovascular
diseases is rapidly increasing not only in adults but, especially, even among the
young individuals. In view of the dreadful consequences, management of diabetes has been
posing one of the biggest threats as well as the challenges with severe impact on
socioeconomic structure of all the nations globally. Dietary intervention has been one of the
most recommended remedies and is being modified to exert a positive impact in the
prevention and management of chronic diseases, especially, diabetes and obesity.
The glycemic load as well the glycemic index of the diet that possibly have the greatest
effect on blood glucose influencing postprandial glucose level. Conventional high
carbohydrate diets, even when based on wholegrain foods, increase postprandial glycemia
and insulinemia and may compromise weight control via mechanisms relating to appetite
stimulation, fuel partitioning and metabolic rate. Although most experts agree that glycemic
load is a relatively a reliable predictor of postprandial blood glucose, the impact and
3
relative importance of the type or source of carbohydrate component on postprandial
glucose level has continued to be an area of intense investigation.
As the daily average consumption of sugar and high fructose corn syrup globally has
significantly increased over the years, the critical role of sugar in diabetes management and
progression is undeniable. Hence, attempts are underway either to reduce the use of sugar
(sucrose) or even eliminate so that naturally occurring sugars should be restricted in the
diet. However, in an attempt to please the sensory appeal of diabetics for sweet taste, the
food and beverage industry uses a wide categories of natural and/or artificial sweeteners
(sucralose, sugar alcohols or polyols, stevia and aspartame) in a variety of products. Some
of the inherent disadvantages of artificial sweeteners include- bitter after taste, heat
unstable, lack of bulk and some products containing alternative sweeteners may still be
high in saturated fat and are therefore not healthy. In addition, it has been recently reported
that artificial sweeteners induce glucose intolerance by altering gut microbiota, which can
also potentially influence an ultimate weight gain by the individual.
The contribution of carbohydrates to postprandial glycemia depends on their glucogenic
ability and not on the size of carbohydrate molecule. This concept has been gaining
acceptance in the context of pathogenesis of diabetes since the emergence of the GI
paradigm in specific. GI is, a measure of the change in blood glucose following ingestion of
carbohydrate containing foods. It has been suggested that the judicious selection of
carbohydrate foods with low GI could potentially help in improvement of conditions
associated with poor glycemic control. In an attempt to clarify the issue of the effect of low
GI diets in the management of type 1 and type 2 diabetes. Studies have been conducted
which indicate that a low GI diet lowered glycated hemoglobin (HbA1C) levels by 0.43%
when compared with a high GI diet with findings similar in both type 1 and type 2 diabetes.
Thus, there arises a need to develop a composition which does not have side effects and is
also able to reduce the glycemic index of food and beverages comprising the composition.
The composition has the same sweetness, calories and functionality as regular sugar, but a
4
significantly lower GI than the regular counterpart that is ideal for the use in food and
beverage industry.
Summary:
While the present invention is described herein by way of example using several
embodiments and illustrative drawings, those skilled in the art will recognize that the
invention is not limited to the embodiments of drawing or drawings described, and are not
intended to represent the scale of the various components. Further, some components that
may form a part of the invention may not be illustrated in certain figures, for ease of
illustration, and such omissions do not limit the embodiments outlined in any way. It
should be understood that the drawings and detailed description thereto are not intended to
limit the invention to the particular form disclosed, but on the contrary, the invention is to
cover all modification/s, equivalents and alternatives falling within the spirit and scope of
the present invention as defined by the appended claims. The headings used herein are for
organizational purposes only and are not meant to be used to limit the scope of the
description or the claims. As used throughout this description, the word "may" is used in a
permissive sense (i.e. meaning having the potential to), rather than the mandatory sense (i.e.
meaning must). Further, the words "a" or "an" mean "at least one” and the word “plurality”
means one or more, unless otherwise mentioned. Furthermore, the terminology and
phraseology used herein is solely used for descriptive purposes and should not be construed
as limiting in scope. Language such as "including," "comprising," "having," "containing,"
or "involving," and variations thereof, is intended to be broad and encompass the subject
matter listed thereafter, equivalents, and additional subject matter not recited, and is not
intended to exclude other additives, components, integers or steps. Likewise, the term
"comprising" is considered synonymous with the terms "including" or "containing" for
applicable legal purposes. Any discussion of documents, acts, materials, devices, articles
and the like is included in the specification solely for the purpose of providing a context for
the present invention. It is not suggested or represented that any or all of these matters form
part of the prior art base or were common general knowledge in the field relevant to the
present invention.
5
In this disclosure, whenever a composition, an element or a group of elements is preceded
with the transitional phrase "comprising", it is understood that we also contemplate the
same composition, element or group of elements with transitional phrases "consisting
essentially of, "consisting", "selected from the group of consisting of, "including", or "is"
preceding the recitation of the composition, element or group of elements and vice versa.
An objective of the present invention relates to provide a composition for lowering
glycemic index of foods and beverages, said composition comprises aqueous extract of:
fenugreek seeds;
blackpepper seeds
pomegranate seeds;
cinnamon bark;
gooseberry fruit;
turmeric root; and
dry ginger root;
wherein said composition is added to food products and beverages for lowering of glycemic
index.
Yet according to another embodiment of the invention, wherein the water is purified by
reverse osmosis and has a pH value from 7.2 to 7.8.
Yet according to another embodiment of the invention, wherein extract of turmeric root
ranges in an amount ranging from 50 to 100 gm; and extract of dry ginger root ranges in an
amount ranging from 50 to 100 gm; per litre of water.
Yet according to another embodiment of the invention, wherein the % amount of each
ingredient is:
6
extract of fenugreek seeds ranges in an amount ranging from 0.02 to 0.15% by weight of
total composition;
extract of blackpepper seeds ranges in an amount ranging from 0.02 to 0.15% by weight of
total composition;
extract of pomegranate seeds ranges in an amount ranging from 0.02 to 0.15% by weight of
total composition;
extract of cinnamon sticks ranges in an amount ranging from 0.02 to 0.15% by weight of
total composition;
and extract of gooseberry fruit ranges in an amount ranging from 0.02 to 0.15% by weight
of total composition;
and other pharmaceutically acceptable excipients, making composition to 100% by weight.
Yet according to another embodiment of the invention, wherein the composition is added to
commercial grade cane sugar to form a lower glycemic index sugar composition for use in
foods and beverages.
Yet according to another embodiment of the invention, wherein the GI index of
composition is 44.4.
Yet according to another embodiment of the invention, wherein the composition is
thermally stable upto a temperature of 300 degree C.
Yet according to another embodiment of the invention, the composition for lowering
glycemic index of foods and beverages can be added to any kind of food and beverages
product wherein commercial grade cane sugar is used.
Yet according to another embodiment of the invention, wherein the food and beverages
include all kind of fruit blends, sauces, purees, fruit juices, cereal flours, and cereal
preparations.
7
Yet according to another embodiment of the invention, the composition is added to any
polished white rice to form a lower glycemic index polished white rice for use in normal
meals or in preparation of breakfast items such as iddly and dosa.
Yet according to another embodiment of the invention, wherein the GI index of rice is 49.9.
Yet according to another embodiment of the invention, the composition is added to any
whole wheat or multi-grain flour to form a lower glycemic index whole wheat or multigrain
wheat flour for use in normal meals or in preparation of various products such as
breads, and other wheat based products
Yet according to another embodiment of the invention, wherein the GI index of whole
wheat flour is 39.
Yet according to another embodiment of the invention, there is provided a process for
preparation of a composition for lowering glycemic index of foods and beverages, said
process comprises:
(i) preparing an extraction solvent by extract of dry ginger root and turmeric root in
water;
(ii) extracting black pepper seeds, extracting fenugreek seeds; extracting
pomegranate seeds; extracting cinnamon sticks; and extracting gooseberry fruit
in extraction solvent of step (i) in individual extraction set up; to obtain
extraction slurry of each black pepper seeds, fenugreek seeds; pomegranate
seeds; cinnamon sticks; and gooseberry fruit
(iii) mixing and homogenizing extraction slurry of each black pepper seeds,
fenugreek seeds; pomegranate seeds; cinnamon sticks; and gooseberry fruit
obtained in step (iii);
(iv) filtering the conditioned extract of step (iii) to obtain filtrate, to make the
composition.
8
Yet according to another embodiment of the invention, the process further comprising
combining the filtrate obtained in step (iv) with cane sugar and drying to obtain a lower
glycemic index sugar composition.
Yet according to another embodiment of the invention, wherein 30-60 ml of filtrate is
added to 1 kg of cane sugar.
Yet according to another embodiment of the invention, wherein the sugar is dried at a
temperature ranging from 40 to 70 degree C.
Brief description of drawings:
So that the manner in which the above recited features of the present invention can be
understood in detail, a more particular description of the invention, briefly summarized
above, may be had by reference to embodiments, some of which are illustrated in the
appended drawings. It is to be noted, however, that the appended drawings illustrate only
typical embodiments of this invention and are therefore not to be considered limiting of its
scope, for the invention may admit to other equally effective embodiments.
These and other features, benefits and advantages of the present invention will become
apparent by reference to the following text figures, with like reference numbers referring to
like structures across the views, wherein:
Figure 1 shows mean blood glucose values upon the consumption of sugar composition
Figure 2 shows blood glucose response after meals containing either 50 gm glucose alone
(control), or Test Food(s) developed using the sugar composition products (Test Food- 50
gm equivalent carbohydrate). Data are expressed as Mean ± S.D. (n= 10). Figure 2a lemon
tea premix, Figure 2b millet cookies, Figure 2c mixed fruit jam, Figure 2d tomato ketchup.
Figure 3 shows HPLC graph for herbal extract composition.
Figure 4 shows the changes in blood glucose levels were lower upon the administration of
sugar composition when compared to standard glucose.
9
Detailed description of invention:
The present invention is described hereinafter by various embodiments with reference to
the accompanying drawings, wherein reference numerals used in the accompanying
drawings correspond to the like elements throughout the description. This invention may,
however, be embodied in many different forms and should not be construed as limited to
the embodiment set forth herein. Rather, the embodiment is provided so that this disclosure
will be thorough and complete and will fully convey the scope of the invention to those
skilled in the art. In the following detailed description, numeric values and ranges are
provided for various aspects of the implementations described. These values and ranges are
to be treated as examples only, and are not intended to limit the scope of the claims. In
addition, a number of materials are identified as suitable for various facets of the
implementations. These materials are to be treated as exemplary, and are not intended to
limit the scope of the invention.
Present invention provides a composition for lowering glycemic index of foods and
beverages; and a process for preparation thereof.
The composition of present invention, in spite of having the same sweetness and
functionality as regular sugar (GI 63.0), it has a significantly low GI of 44.4. More
importantly, this sugar appears to be potentially effective in reducing the GI of existing
foods without modifying their ingredient profile and thus finds wide application in the
functional food and beverage industry in a bid to help managing glycemic control of
diabetics.
Experiments
Process for preparation of the composition:
Raw Materials:
10
Raw materials used in the process are Turmeric, Dry Ginger, Fenugreek, Black Pepper,
Pomegranate, Cinnamon and Gooseberry. The source of raw material is open market. Good
quality raw materials are procured in the open market.
Process Materials:
The process uses RO based plant for process water. The RO plant supplies water at pH
value 7.2 to 7.8.
Manufacturing Process:
Step 1:Natural solvent preparation: A natural solvent is prepared using dry ginger and
turmeric with water, by adding 75 gms of dry ginger and75 gms of turmeric powder in 1
litre water.
Step 2:The natural solvent prepared in step 1 is used to extract pepper. 200 grams of solvent
extract provides100 grams of black pepper extract.
Step 3:The natural solvent prepared in step 1 is used to extract cinnamon. 200 grams of
solvent extract provides 80 grams of cinnamon extract.
Step 4: The natural solvent prepared in step 1 is used to extract from gooseberry. 200 grams
of solvent extract provides120 grams of gooseberry extract.
Step 5: The natural solvent prepared in step 1, is used to extract fenugreek.200 grams of
solvent extract provides 80 grams of fenugreek extract.
Step 6: The natural solvent prepared in step 1, is used to extract pomegranate seeds. 200
grams of solvent extract provides 60 grams of pomegranate extract.
11
The extracted components available in step 1 to 6 were added in the ratio of 1: 6 parts of
fresh RO water in a particular order to ensure optimal thermodynamic solution stability and
kept overnight to obtain a slurry.
The herbal extract slurry is filtered in a batch filtration step using multi-layer cotton fibre
filters.The final product after the seven stage filtration process is a clear herbal solution.
The water based herbal solution, crystal clear water without turbidity.
Physical characteristics:
The physical characteristics of the aqueous herbal extract are given below:
Turbidity – 0,
Odour – less than 5 Hazen
pH value - 7.4 to 7.8
Boiling point - 1000 C
Freezing point - 00 C
Examples:
The herbal solution obtained from process as mentioned above was added to cane sugar
decreased the GI of sugar and composition was used in the preparation of different food
products markedly reduced their GIs. This novel and innovative product could be a
potentially effective method for reducing the GI of existing foods without modifying their
ingredient profile. Given the interest and potential benefits of low GI diets, further studies
of DHS with a larger study population and in combination with other high GI foods are
indicated. The herbal solution used in the manufacture of composition is made up of herbs
that possess anti-diabetic properties. The use of this product may potentially have positive
health implications and further research is therefore warranted to confirm the long term
health benefits of this novel herbal low GI sugar.
12
The test products used in the study include: composition and the food products (lemon tea
premix, millet biscuits, mixed fruit jam and tomato ketchup) developed using the
composition. Nutritional composition of each of the products is shown in table 1.
Accelerated shelf life testing of the composition was performed to determine the date until
the product remained safe with the defined quality. The composition was stored in specific
environment of controlled temperature (45°C) and humidity (80% - 90%). The test sample
was analyzed for microbiological (total plate count, yeast/mould, coliform, E.coli),
organoleptic/sensory (color, odor and taste) and chemical (moisture and pH/acidity)
parameters on days 0, 8, 16, 24 and 32. Results of the accelerated shelf life study with sugar
composition estimated that the product may be used safely within 2 years from the date of
manufacture.
Table 1: Nutrient Composition of Test Food(s)
Component Herbal Lemon Millet Mixed Tomato
Composition of
invention Premix Cookies Fruit Jam Ketchup
Energy (kcal/100g) 400 400 521.6 290 151
Fat (g/100g) 0 0.61 26.29 Traces 0.1
Saturated Fatty Acids
0 0 15.71 0 0
(g/100g)
Trans Fatty Acids (g/100g) 0 0 0.00 0 0
Protein (g/100g) 0 0.36 5.92 Traces 1.5
Total Carbohydrates
99.6 96.0 65.33 71 36.0
(g/100g)
Added Sugar (g/100g) 0 91.0 0 63 31.0
Dietary Fibre (g/100g) 0.0 0.0 0.31 0 2.5
Sodium (mg/100g) 5.7 5.6 84.54 0 880
13
Calcium (mg/100g) 15.9 15.6 0 0 0
Magnesium (mg/100g) 0.8 0.7 0 0 0
Process of manufacture of the herbal solution, the composition comprising cane sugar and
the related food products is described herewith. The herbal solution is prepared using
techniques from the Indian Traditional Systems of Medicine and is an aqueous extract of
seven herbs viz., turmeric (rhizome), ginger (rhizome), fenugreek (seeds), black pepper
(fruit), pomegranate (fruit seeds), cinnamon (bark), gooseberry (fruit). Each of the herbs is
individually extracted using a unique process. Individual aqueous extracts are then filtered
and blended to yield a colorless and odorless solution.
The composition when mixed with cane sugar forms a sugar composition of low GI. The
sugar composition is a novel product manufactured by using a proprietary process wherein
regular cane sugar is blended for 30 min with the herbal solution (40 ml/ kg of sugar). After
the blending, the wet sugar is unloaded into a container and left undisturbed overnight.
Subsequently, the sugar is further dried at 60°C to get the final consumable product is
crystalline and white in color. No change in physical (color), or chemical property was
observed for cane sugar after manufacturing the final product. Lemon Tea Premix-sugar
composition is powdered and mixed with instant tea and dehydrated lemon powder in a predetermined
ratio under dehumidified condition (27% relative humidity) and packed.
Mixed Fruit Jam- Fruits are cut and pulped using a fruit miller and pulper. The sugar
composition (30 ml/ kg of pulp) is mixed with the fruit pulp. Sodium benzoate and citric
acid were added. Once the total mass reaches solid content level of 70 Brix (measured
using a refractometer), pectin (0.05%), coloring and flavoring agents are added (0.05%).
The fruit pulp is boiled till the mass reaches 68 Brix. Then it is filled into bottles and
allowed to cool.
14
Tomato Ketchup- The sugar composition (25 ml/ kg of tomato paste) is added to the tomato
paste along with known quantities of water (100-200 g/l). Sodium chloride, sodium
benzoate, xanthan gum and onion powder are mixed to this solution. This is boiled till the
mixture reaches a desirable mass (40 Brix). Liquid starch is added at this stage, along with
garlic oleoresin acetic acid and tomato ketchup Flavor. The process is stopped once the
mass reaches 38 Brix. Tomato Ketchup is filled hot in the food grade virgin glass bottles.
Millet Cookies- Barnyard and Kodo millet flour (50/50 ratio) is blended with whole wheat
flour (45%:55%). Mixed flour (60%) is combined with baking powder; trans-fat free
hydrogenated fat (25%) and powdered sugar (15%). The sugar composition is added at the
rate of 40 ml/kg of powdered sugar. All the ingredients are creamed and about 30 % water
was added to prepare the dough. The prepared dough was rolled into cookies (0.75 cm
thickness and 5 cm diameter), and baked under standard conditions.
Rice: 50 ml of the said herbal solution was blended uniformly with one kg of Sona Mahsuri
polished white rice and cooked in required amount of water.
Whole Wheat flour: 40 ml of the said herbal was blended uniformly with one Kg of whole
wheat flour and kneaded. The kneaded whole wheat flour was rolled into balls and made
into chapattis. No oils or ghee was used in making chapattis.
Seven non-blind, repeated measure, crossover design trials were undertaken in seven
groups of healthy subjects [mean age of 30.2±6.9 years]. Each trial was conducted at
random and on separate days. Subjects were moderately active, non-smokers and nonalcoholics.
Participants who were aged below 18 years or above 55 years, and those with
fasting blood sugar values of <100 mg/dl were excluded from the study. GI testing was
conducted with 10 subjects according to the ISO 26642:2010 [21] guidelines. All studies
used glucose as the standard food. Subjects were also required to fast for 10 hours prior to
their study visit. The study protocol was approved by the Institution Ethics Committee.
15
Test Food
On each test day, subjects arrived at the study centre in the morning after a 10 hour
overnight fast. 50 gm of sugar composition or 50 gm carbohydrate equivalent of food
products developed using the same herbal sugar (lemon tea premix, millet biscuits, mixed
fruit jam, tomato ketchup, rice and whole wheat flour) and 50 gm of standard food- glucose
were used in the study. Oral Glucose Tolerance Test (OGTT) was performed in the
morning after 10 hr of overnight fasting. After collecting blood sample to determine fasting
blood glucose the test food was administered orally with adequate quantities of water.
Subjects consumed the standard food/ or test food in a crossover model on different days
(at least 2-3 days of interval between each OGTT).
Blood Analysis
Blood samples were collected every 15 min in the first hour and every 30 minutes in the
second hour (0, 15, 30, 45, 60, 90 and 120 min after administration of standard food/ or test
food). Blood glucose concentration was determined by Glucose Oxidation method.
Calculation of Glycemic Index
The GI was calculated according to the FAO/WHO/ISO 26642:2010 standards 20, 21,
which utilizes capillary blood glucose measurements. As per this protocol, when a blood
glucose value fell below the baseline, only the area above the fasting level was included.
HPLC Analysis
The HPLC profile comparison was carried out for five concentrate samples from the sugar
composition (Fig.3). The details of HPLC analysis were given in Table 4.
Table 4: HPLC analysis: Profile comparison for the five concentrate
samples
S.NoSample &Peak 1 Peak 2 Peak 3 Peak 4 Peak 5
batch No Ret.Time %Ret.Time% Ret.Time% Ret.Time% Ret.Time%
16
min areamin area min areamin area min area
KVP‐2011‐X
1 4.75 4.79 11.23 36.49 12.24 4.15 13.33 24.62 16.80 12.10
(08‐07‐2014)
KVP‐2011‐X
2 4.76 4.25 11.21 36.42 12.23 4.20 13.32 23.93 16.77 12.11
(10‐07‐2014)
KVP‐2011‐X
3 4.78 4.30 11.23 35.61 12.23 3.91 13.33 23.74 16.78 12.58
(12‐07‐2014)
KVP‐2011‐X
4 4.76 4.31 11.21 35.51 12.23 3.85 13.33 23.33 16.80 11.52
(14‐07‐2014)
KVP‐2011‐X
5 4.76 4.34 11.21 36.56 12.23 3.99 13.33 23.92 16.79 11.98
(16‐07‐2014)
0.23
6 % RSD 5.04 0.10 1.42 0.04 3.76 0.03 1.95 0.08 3.14
Note: The %RSD for retention time of all the five peaks is > 0.5%. This shows the method
consistency for the identical compounds. The %RSD for the %area of all the five peaks is <
5.5% and this infers the consistency in the composition of the concentrated samples.
17
Statistical Analysis
For each test, the incremental area under the curve was calculated according to the
trapezoidal method. Any area under the baseline (fasting value) was ignored. Results
represented as means. GI of test food is expressed as mean for the whole group.
RESULTS
Nutrient Composition of sugar composition and foods produced using it
Nutrient composition of sugar, rice, whole wheat and the fourfoods namely Lemon Premix,
Millet Cookies, Mixed Fruit Jam and Tomato Ketchup produced using sugar composition
were presented in table 1.
While tomato ketchup showed the least energy with 121 kcals (/100 g), mixed fruit jam
(290), sugar composition (400), lemon premix (400) contained more energy with millet
cookies showing (521) the highest energy mostly due to the presence of 15.7g saturated
fat/100g. Otherwise, all the foods showed no trans or saturated fat in the products.
GI Studies
The mean blood glucose values upon the consumption of sugar composition (Fig. 1) and
the 4 different test foods and standard food (glucose) were given in fig. 2. Blood glucose
levels after consumption of test foods were lower at any time interval studied compared to
glucose. The incremental area under curve (iAUC) of all the test foods was much lower
when tested against the standard. Considering the iAUC of the standard glucose as 100%,
the mean % iAUCs of DHS; lemon premix; millet cookies; mixed fruit jam and of tomato
ketchup were calculated and presented in table 2.
18
Table 2: % iAUC of the blood sugar response to various food products
Product %AUC Mean SD
Glucose 100
Cane sugar 80.61
Composition of present invention 55.24 5.84
millet Cookies with composition of
invention 86.59 2.16
Mixed fruit Jam 54.09 3.64
Lemon tea 48.00 2.61
Tomato Ketchup 60.97 2.83
N= 10
The GI values of the various test food measured were given in table 3, calculated based on
the iAUCs. Sugar composition showed lower GI (44.4) compared to that of cane sugar (63),
emphasizing that sugar composition is certainly a diabetic friendly novel natural sugar
substitute with no compromise on taste. Rice composition showed lower GI (49.9)
compared to that of normal rice GI (70.8). The four food products produced using sugar
composition: also showed GIs in the decreasing order of lemon tea mix: 50.9, fruit jam:
45.5, tomato ketchup 38.8 and millet cookies with the lowest GI 15.
Table 3: Glycemic Index of Cane Sugar, Diabliss Herbal Sugar and the
Derivative Products
Test Food Glycemic Index (Mean ± S.D.)
Cane Sugar 63.0
19
Composition of present invention 44.4 ± 5.8
Millet Cookies with composition
of invention 14.8 ± 4.8
Lemon Tea with composition of
invention 50.9 ± 2.4
Mixed Fruit Jam with composition
of invention 45.5 ± 3.2
Tomato Ketchup with
composition of invention 38.8 ± 2.8
N= 10
As, GI values were often grouped into categories as producing either a low, medium or
high glycemic response with the cut-off values are as follows: low <55; medium 56–69
inclusive; high >70.7. Hence, based on the GI data of this study, sugar composition having
shown a GI of 44.4 may be classified as a low GI food as regular table sugar or sucrose has
a GI of 65. More importantly, this low GI sugar when substituted for regular sugar in the
food products (lemon tea premix, millet biscuits and tomato ketchup), demonstrated a
decrease in the GI of the new products and thus classifying them as low GI foods. The
interesting outcome of these foods using sugar composition was that millet cookies, though
contain 521.6 kcals/100g showed a GI of 15 and the lowest energy food tomato ketchup
with 151 kcals/100g showed a GI of 38.8.
HPLC Analysis
All the HPLC peaks are consistent for all the five samples. Lowering postprandial blood
glucose levels and glycemic load is one of the current methods in management and
prevention of both obesity and diabetes. Prevention and management of diabetes should
begin before or during the Impaired Fasting Glucose and/or Impaired Glucose Tolerance
stage. While pharmacological therapies are evidently effective, a holistic combination of
20
lifestyle changes, functional foods/nutraceuticals along with drugs can be more effective in
not only delaying the onset of diabetes but also in achieving better glycemic control in prediabetic
and diabetic populations.
One of a growing number of products known as "functional" foods is now available for
diabetics. These foods contain biologically active components to help people with diabetes
manage their disease by improving glycemic control and lowering risk factors for long-term
complications.
It has been reported that the intake of low GI diets is associated with glycemic decreases,
and lower and more consistent postprandial insulin release, avoiding the occurrence of
hypoglycemia. Moreover, consumption of a low GI diet has been indicated as beneficial for
reducing body weight, total body fat and visceral fat, levels of proinflammatory markers
and the occurrence of dyslipidemia and hypertension. Advantages and health benefits of
low glycemic index foods have been reported that include in the health of diabetics and prediabetics,
obesity, lipid oxidation and body composition, childhood management of obesity
and reducing the risk of metabolic disease.
Functional foods, with their specific health effects, represent a new mode of thinking about
the relationships between food and health in everyday life. Many of the diabetes functional
foods entering the marketplace are modified, enhanced, fortified, or supplemented in order
to manage diabetes. Manyfunctional ingredients from both plants and animals have been
described for the treatment of diabetes throughout the world. These ingredients have been
extensively researched and also used as traditional medicine components.
Experiment related to safety and efficacy of sugar composition in patients with
Diabetes Mellitus (type-2):
Methods: The study was conducted in two phases. In the first phase glycemic index of
sugar composition was determined in 10 healthy volunteers against standard glucose in a
non-blind, repeated measure, cross-over design. In the second phase, a prospective
observational clinical trial was conducted in 100 adult diabetic patients of both genders and
21
sugar composition was administered (25 g/day) for 90 days. A baseline fasting blood
sample was obtained on day zero and thereafter, three more blood samples were taken
every 30 days. The samples were analyzed for the fasting blood glucose, HbA1c, lipid
profile and safety parameters.
Results: The GI value of the herbal sugar was found to be 44.4. Thus, sugar composition
can be considered as a low glycemic nutrient/food. Long term administration of sugar
composition does not increase blood glucose and the lipid profile was not altered. There
appears to be a decrease in HbA1c and a decrease in serum alkaline phosphatase levels, but
these initial findings are not statistically significant and need further investigations. No
significant differences were observed in other safety parameters from baseline values to
study end.
Results show that sugar composition is a safe substitute for conventional sugar and does not
increase the blood glucose and lipid levels. It is also observed that sugar composition does
not produce any adverse effects on consumption by diabetic patients and in addition there
seems to be a decrease in trend of HbA1c levels thereby indicating there is a beneficial
effect on the average blood sugar levels. However a prospective similar study with a large
number of patients is needed to confirm the results of efficacy.
Materials and Methods
Subjects and Methods
Phase I
Subjects: Ten healthy adult subjects were recruited for the study. Subjects were moderately
active, non-smoking and non-alcoholics. Exclusion criteria were as follows: age, 55 years;
BMI >25 kg/m2; fasting blood glucose value >120 mg%. Mean age of the subjects was ≥
30 years.
Study Design: Non-blind, repeated measure, crossover design trial.
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Study protocol: The protocol used was in line with the procedures recommended by the
Food and Agriculture Organization/World Health Organization. To determine the glycemic
index (GI) of sugar composition, on the day prior to the test, subjects were asked to restrict
their activities and not to eat or drink after 21.00 hours the night before the test, although
water was allowed. Test food: 50 grams of sugar composition. The standard food consisted
of 50 g of glucose. Glucose tolerance test (GTT) was performed as follows. After an
overnight fasting (12h) the blood sample was collected and the subjects were asked to
consume the glucose or sugar composition in a crossover model on a different day. The gap
between the two GTT tests was a minimal of three days after completing the first test with
glucose. A fasting intravenous blood sample was taken at 0 min and glucose or sugar
composition was consumed immediately after this. Further blood samples were taken at 30,
60, 90 and 120 min for the estimation of blood glucose by glucose oxidase method.
Calculation of GI: The incremental area under the Curve (iAUC), ignoring the area
beneath the baseline, was calculated geometrically for each food6. The iAUC for each
subject was expressed as a percentage of the mean iAUC for the standard food taken by the
same subject. The GI of sugar composition was taken as the mean for the whole group.
Statistical analysis was performed using SPSS. Statistical significance was set at p< 0·05.
Phase II
A prospective observation study was initiated involving100 diabetic patients (Type-2) who
were in the age range of 30 to 55 years with fasting blood glucose levels in between 150-
200 mg/dL besides surviving with standard medication. The exclusion criteria were:
patients withdiabetes associated retinopathy, nephropathy and cardiovascular disease;
lactating women, patients with recent stroke and heart attack, fasting glucose levels more
than 200 mg/dL, abnormal blood urea and creatinine. Written informed consent was
obtained from each patient after the GTT process was explained in their local language.
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Patients were given sugar composition at 25g/day for 90 days and the subjects were asked
to consume the same amount at different times of the day (two or three times / day). At the
beginning and at the end of the study the glycosylated hemoglobin, lipid profile, kidney and
liver function tests were performed. The fasting blood glucose levels were measured at the
beginning of the study, 7, 30, 60 and 90 days after commencement of sugar composition
intake.
Statistical Analysis
Statistical analysis was carried out using SPSS 10.0 and p values were set at 0.05 as
significant. Repeated measures of ANOVA and students‘t’ was applied to observe the
changes in end parameters.
The results of first phase study revealed that administration of sugar composition exhibited
low GI value compared to standard glucose in healthy subjects. The changes in blood
glucose levels were lower upon the administration of sugar composition when compared to
standard glucose (figure.4). For practical measures, GI values are often grouped into
categories as producing either a low, medium or high glycemic response. The cut-off GI
values are as follows: low <55, medium 56-69, high >70. The GI of sugar composition was
found to be 44.4 and thus the sugar composition can be grouped as a low glycemic food.

Claims:
WE CLAIM:
1. A composition for lowering glycemic index of foods and beverages, said composition
comprises aqueous extract of:
fenugreek seeds;
blackpepper seeds
pomegranate seeds;
cinnamon bark;
gooseberry fruit;
turmeric root; and
dry ginger root;
wherein said composition is added to food products and beverages for lowering of glycemic
index.
2. The composition as claimed in claim 1, wherein the water is purified by reverse
osmosis and has a pH value from 7.2 to 7.8.
3. The composition as claimed in claim 1, wherein extract of turmeric root ranges in an
amount ranging from 50 to 100 gm; and extract of dry ginger root ranges in an amount
ranging from 50 to 100 gm; per litre of water.
4. The composition as claimed in claim 1, wherein the % amount of each ingredient is:
extract of fenugreek seeds ranges in an amount ranging from 0.02 to 0.15% by weight of
total composition;
extract of blackpepper seeds ranges in an amount ranging from 0.02 to 0.15% by weight of
total composition;
extract of pomegranate seeds ranges in an amount ranging from 0.02 to 0.15% by weight of
total composition;
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extract of cinnamon sticks ranges in an amount ranging from 0.02 to 0.15% by weight of
total composition;
and extract of gooseberry fruit ranges in an amount ranging from 0.02 to 0.15% by weight
of total composition;
and other pharmaceutically acceptable excipients, making composition to 100% by weight.
5. The composition as claimed in claim 1, wherein the composition is added to
commercial grade cane sugar to form a lower glycemic index sugar composition for use
in foods and beverages.
6. The composition as claimed in claim 1, wherein the GI index of composition is 44.4.
7. The composition as claimed in claim 1, wherein the composition is thermally stable
upto a temperature of 300 degree C.
8. The composition as claimed in claim 1, the composition for lowering glycemic index of
foods and beverages can be added to any kind of food and beverages product wherein
commercial grade cane sugar is used, wherein the food and beverages include all kind
of fruit blends, sauces, purees, fruit juices, cereal flours, and cereal preparations,
wherein the composition is added to any polished white rice to form a lower glycemic
index polished white rice for use in normal meals or in preparation of breakfast items
such as iddly and dosa.
9. The composition as claimed in claim 8, wherein the GI index of rice is 49.9.
10. The composition as claimed in claim 1, the composition is added to any whole wheat or
multi-grain flour to form a lower glycemic index whole wheat or multi-grain wheat
flour for use in normal meals or in preparation of various products such as breads, and
other wheat based products, wherein the GI index of whole wheat flour is 39.
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11. A process for preparation of a composition for lowering glycemic index of foods and
beverages, said process comprises:
(i) preparing an extraction solvent by extract of dry ginger root and turmeric root in
water;
(ii) extracting black pepper seeds, extracting fenugreek seeds; extracting
pomegranate seeds; extracting cinnamon sticks; and extracting gooseberry fruit
in extraction solvent of step (i) in individual extraction set up; to obtain
extraction slurry of each black pepper seeds, fenugreek seeds; pomegranate
seeds; cinnamon sticks; and gooseberry fruit
(iii) mixing and homogenizing extraction slurry of each black pepper seeds,
fenugreek seeds; pomegranate seeds; cinnamon sticks; and gooseberry fruit
obtained in step (iii);
(iv) filtering the conditioned extract of step (iii) to obtain filtrate, to make the
composition.
12. The process as claimed in claim 11, further comprising combining the filtrate obtained
in step (iv) with cane sugar and drying to obtain a lower glycemic index sugar
composition.
13. The process as claimed in claim 11, wherein 30-60 ml of filtrate is added to 1 kg of
cane sugar.
14. The process as claimed in claim 11, wherein the sugar is dried at a temperature ranging
from 40 to 70 degree C.