CLIAMS:1. A food product comprising i) 78.26% to 58.26% by weight of component A and ii) 20.93% to 40.93% by weight of component B and iii) remaining (0.81%) vitamins and minerals, wherein said component A is a combination of resistant maltodextrin, whey protein concentrate, and pea protein concentrate and said component B is a combination of skimmed milk powder, flavours, guar gum, and sucralose.
2. The food product as claimed in claim 1, wherein said food product comprises 33.45% to 44.93% by weight Resistant Maltodextrin.
3. The food product as claimed in claim 1, wherein said food product comprises 16.54% to 22.22% by weight Whey Protein Concentrate (80%).
4. The food product as claimed in claim 1, wherein said food product comprises 8.27% to 11.11% by weight Pea Protein Concentrate (84%).
5. The food product as claimed in claim 1, wherein said food product comprises 14.78% to 28.90% by weight Skimmed Milk Powder.
6. The food product as claimed in claim 1, wherein said food product comprises 3.89% to 7.61% by weight Flavours.
7. The food product as claimed in claim 1, wherein said food product comprises 2.22% to 4.34% by weight Guar Gum.
8. The food product as claimed in claim 1, wherein said food product comprises 0.04% to 0.08% by weight Sucralose.
9. The food product as claimed in claim 1, wherein said food product comprises 0.71% by weight Minerals.
10. The food product as claimed in claim 1, wherein said food product comprises 0.08% by weight Vitamins.
11. The food product as claimed in claim 1, wherein said food product comprises 44.93 % by weight Resistant Maltodextrin, 22.22% by weight Whey Protein Concentrate (80%), 14.78% by weight Skimmed Milk Powder, 11.11% by weight Pea Protein {Concentrate (84%)} , 3.89% by weight Flavours; 2.22% by weight Guar Gum; 0.71% by weight Minerals; 0.08% by weight Vitamins , 0.04% by weight Sucralose.
12. The food product as claimed in any of the preceding claims, wherein said food product is in the form of a powder to be mixed with water and consumed, ready to drink liquid beverage, diabetic cereal bar, snack bar, biscuit, cookie, pudding, and chocolate.
13. A process for preparing the food product as claimed in any of claims 1 to 12, wherein said process comprises the steps :
(i) blending resistant maltodextrin, whey protein concentrate (80%) and pea protein concentrate (84%), to make a homogenous mixture for about 10 minutes;
(ii) blending flavours, guar gum, sucralose, vitamins, minerals into a homogenous mix manually or by a ribbon blender, as appropriate, such that a perfect homogenous blend is formed;
(iii) blending skimmed milk powder with the homogenous blend of Step (ii) in a ribbon blender for about 15 minutes to obtain a homogenous blend;
(iv) blending the homogenous mixture of step (i) with the homogenous blend of step (iii) in a ribbon blender, for 15 minutes or till a perfect blend of the food product as claimed in claims 1, 2 or 3 is formed.
,TagSPECI:Field of the Invention
The present invention relates to food products for diabetic patients. More specifically the present invention relates to food formulation containing high fibre, low fat and zero added sugar for diabetic and cardiovascular health.

Background and the prior art
Dietary fibers are known for their health benefits towards various diseases. However addition of high dietary fiber (more than 8-10g/serving) to powder beverage products (dry blended) negatively impacts the taste, flavour and mouthfeel profiles. Dietary fiber gives a very powdery and raw mouthfeel with raw off notes to the product. Besides, dietary fiber also masks the top notes of the product by not allowing the flavour to dominate. Dietary fibers are also known for their low dissolution rate in water and the thickening effect. Dietary fibers promote beneficial physiological effects including laxation, and/or blood cholesterol attenuation, and/or blood glucose attenuation (American Association of Cereal Chemists (2001) ‘The definition of dietary fiber’, Cereal Foods World, Vol 46(3), pp112-126). Type 2 diabetes can be prevented or treated by increasing the amounts and varieties of fiber-containing foods (American Dietetic Association (2008) ‘Position of the American Dietetic Association: Health Implications of Dietary fiber’, Journal of the American Dietetic Association, Vol 108, pp1716-1731). The long-term ingestion of 50g dietary fiber per day for 24 weeks significantly improved glycemic control and reduced the number of hypoglycemic events in individuals with type 1 diabetes (Giacco R, Parillo M, Rivellese AA, Lasorella G, Giacco A, D’Episcopo L, Riccardi G (2000) ‘Long-term dietary treatment with increased amounts of fiber-rich low-glycemic index natural foods improves blood glucose control and reduces the number of hypoglycemic events in type 1 diabetic patients’, Diabetes Care, Vol 23, pp1461-1466). Studies of individuals with type 2 (non–insulin dependent diabetes) suggest that high fiber intakes diminish insulin demand (Simpson HCR, Simpson RW, Lously S, Carter RD, Geekie M, Hockaday TDR (1981) ‘A high carbohydrate leguminous fiber diet improves all aspects of diabetic control’, Lancet, Voli, pp 1-15). Apart from diabetes, dietary fiber is also beneficial for cardiovascular health. The hypocholesterolemic effects associated with soluble fiber consumption are clear from the animal model and human clinical investigations (http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2605338/ (Accessed on April 3, 2013)). Several large-scale cohort studies have documented that dietary fiber lowers the risk for coronary heart disease. The physicochemical properties of soluble fiber result in important modifications in volume, bulk and viscosity in the intestinal lumen, which will alter metabolic pathways of hepatic cholesterol and lipoprotein metabolism, resulting in lowering of plasma LDL-cholesterol (Fernandez ML (2001) ‘Soluble fiber and nondigestible carbohydrate effects on plasma lipid and cardiovascular risk’, Current opinion in Lipidology, Vol 12 (1), pp 35-40). Hence, it is important to formulate a product with high fiber content.

Fat in all powder beverage formulations (dry blended products) plays a very vital role in enhancing the sensory profiles. It enhances the mouthfeel and taste of the product to a substantial extent and also enhances the flavour. To keep fat to low levels in a formulation with high dietary fiber will make the product unappealing from a sensory point of view. But, from a health point of view fat plays a contradictory role for diabetic patients. Research has shown that dietary fat and free fatty acids (FFAs) impair insulin sensitivity and increase glucose production. Studies of people with type 1 diabetes have shown that higher-fat pizza meals cause hyperglycemia hours after being consumed. Study results showed that participants required more insulin after eating the high-fat dinner than the low-fat dinner (12.6 units compared to 9 units). Despite the increased insulin, participants had greater hyperglycemia after the high-fat dinner, with insulin levels elevated five to ten hours after the meal (http://www.joslin.org/dietary-fat-can-affect-insulin-requirements-in-type-1-diabetes.html (Accessed on April 2, 2013)). Therefore, it is advisable to avoid a high fat diet when suffering from diabetes. A high fat diet is also not recommended for cardiovascular patients. But it becomes a difficult task to formulate a tastier powder beverage with high amounts of dietary fiber, low levels of fat, nil added sugars and high protein that dissolves in water instantly. Most of the instant powder drinks for diabetic population are having low fiber content per serving of upto 5g approx. Most of these powder drinks are having a high amount of fat per serving of upto 8g. The protein content of these drinks is upto 11g per serving. These types of drinks are good for the diabetic populations but these cannot be consumed by the cardiovascular disease patients due to the high amounts of fat in the product.
WO2009135959 discloses food product for enterally or orally feeding a diabetic patient, said product comprising a proteinic mixture (23% of the total energy) based on caseinate, pea protein and milk serum proteins, a lipidic mixture (45% of the total energy) based on vegetable oils and purified fish oil, and a mixture of carbohydrates with a low glycemic index (32 % of the total energy), comprising type IV resistant starch, maltodextrin 5-8 DE, inulin and cellulose and vitamins and minerals. According to WO'959, its formulation contains added oils and 45% of the total energy of the product comes from lipids (oils/fats). WO'959 product thus cannot be consumed by people suffering from diabetes as well as cardiovascular ailments like high cholesterol, high lipid profile due to the high amount of fat present in the product in the form of oils. It’s recommended only for diabetic patients. Much research has also proved that dietary fat and free fatty acids can impair insulin sensitivity and increase glucose production.

EP0768043 teaches a nutritional composition for use by diabetics containing a controlled absorbed carbohydrate component. It illustrates examples of compositions comprising maltodextrin, milk proteins, etc in variable amounts. EP'043 mentions that its product is a refined diabetic product with 0 to 45% fat and a carbohydrate component with sucrose having controlled or sustained absorption. Sucrose is known to raise the blood levels and is not recommended for diabetics. EP'043 further mentions that its invention is directed to a nutritional composition containing moderate to low fat and a carbohydrate component containing a combination of ingredients that provide a fast, moderate, and slow absorption of carbohydrate upon consumption which results in a sustained release of carbohydrate without excessive blood glucose peaks. The product of EP’043 thus contains fats and does not contain high amount of dietary fiber.

Therefore, there is a need to develop a high fiber, low fat, no added sugar drink which is good for the diabetics and cardiovascular patients.

Object of the Invention
It is an object of the present invention to overcome the drawbacks of the prior art.
It is another object of the present invention to provide a low glycemic drink with high fiber content which overcomes the challenges associated with dietary fibers and fats.
It is yet another object of the present invention to provide a low glycemic drink having low fat content, very high fiber content and a tastier beverage with good taste.
It is a further object of the present invention to provide a health drink which is good for both the diabetics and cardiovascular patients.

Brief description of accompanying Figures
Figure 1 illustrates the glycemic response of the composition of the present invention and those of the marketed products.
Figure 2 illustrates the glycemic response of the formulation of the present invention.
Figure 3 illustrates the glycemic response of the formulation of WO'959.
Figure 4 illustrates the glycemic response of the compositions with varying amounts of components.

Summary of the Invention
According to one aspect of the present invention there is provided a food product comprising i) 78.26% to 58.26% by weight of component A and ii) 20.93% to 40.93% by weight of component B and remaining (0.81%) vitamins and minerals, wherein said component A is a combination of resistant maltodextrin, whey protein concentrate, and pea protein concentrate and said component B is a combination of skimmed milk powder, flavours, guar gum, and sucralose.

Detailed Description of the Invention
The present invention relates to a food product comprising: i) 78.26% to 58.26% by weight of component A and ii) 20.93% to 40.93% by weight of component B and remaining (0.81%) vitamins and minerals, wherein component A is a combination of resistant maltodextrin, whey protein concentrate, and pea protein concentrate and component B is a combination of skimmed milk powder, flavours, guar gum, and sucralose.
The present inventors have surprisingly found that the component A and component B when combined in the above weight ratio provide excellent glycemic response as well as an acceptable organoleptic profile.
According to a preferred embodiment of the present invention the food product comprises 33.45% to 44.93% by weight Resistant Maltodextrin; 16.54% to 22.22% by weight Whey Protein Concentrate (80%), 8.27% to 11.11% by weight Pea Protein Concentrate (84%); 14.78%-28.90% by weight Skimmed Milk Powder; 3.89% to 7.61% by weight Flavours; 2.22% to 4.34% by weight Guar Gum; 0.04% to 0.08% by weight Sucralose; 0.71% by weight Minerals; 0.08% by weight Vitamins.

According to the most preferred embodiment of the present invention there is provided a health drink which comprises of the below components as mentioned in Table 1 below.
Table 1
Ingredients (g) Per 100g
Resistant Maltodextrin 44.93
Whey Protein Concentrate (80%) 22.22
Skimmed Milk Powder 14.78
Pea Protein {Concentrate (84%)} 11.11
Flavours 3.89
Guar Gum 2.22
Minerals 0.71
Vitamins 0.08
Sucralose 0.04
Total Quantity (g) 100.0

The product of the present invention has very low amount of available carbohydrates of around 18.8%. The calorific value of the food product was found to be around 304 kcal which is much lower than the market samples.

The product contains a very negligible amount of fat, no added sugar (sucrose), high fiber, and yet it is acceptable from a sensory point of view. Sugar (Sucrose) gives the body and an excellent taste to any product. By removing the sugar (Sucrose) as well as reducing the fat substantially and increasing the dietary fiber and still getting a good sensory profile is a surprising effect achieved by the present invention. Fats and sugar (Sucrose) which are the key taste, flavour, texture (mouth feel) giving components in powder health care food products have been substantially reduced and not added to the product respectively in the present invention; yet the product has a good sensory profile.
The food product of the present invention can be prepared by the process comprising the steps :
(i) blending resistant maltodextrin, whey protein concentrate (80%) and pea protein concentrate (84%), to make a homogenous mixture for about 10 minutes;
(ii) blending flavours, guar gum, sucralose, vitamins, minerals into a homogenous mix manually or by a ribbon blender, as appropriate, such that a perfect homogenous blend is formed;
(iii) blending skimmed milk powder with the homogenous blend of Step (ii) in a ribbon blender for about 15 minutes to obtain a homogenous blend;
(iv) blending the homogenous mixture of step (i) with the homogenous blend of step (iii) in a ribbon blender, for 15 minutes or till a perfect blend of the formulation of the present invention is formed.

The present formulation can be in the form of a powder to be mixed with water and consumed, ready to drink liquid beverage, diabetic cereal bar, snack bar, biscuit, cookie, pudding, chocolate.

The present invention is now illustrated by means of non limiting examples.

Example 1
Composition according to the present invention has been prepared using the components as mentioned in Table 1. The formulation was prepared by dry blending the components as mentioned in Table 1.

Directions for Use (Present Formulation):
36g of powder was mixed in 200 ml of cold water / luke warm water. The mixture is stirred briskly and mixed till the powder dissolves completely. The drink is then ready to be served.

Example 2
Comparison between the glycemic response of the formulation of the present invention compared to that of marketed samples.

Various samples were prepared and tested to compare the formulation of the present invention vis-à-vis the marketed products. The compositions of the various samples are shown in Table 2 below.
Table 2
Ingredients / Names of Components as taken from labels of Competitor Market Samples (Vitamins and Minerals have been combined under the heads – “Vitamins” and “Minerals” respectively.
S.No. Present Invention Market Sample 1 Market Sample 2 Market Sample 3
1 Resistant Maltodextrin Maltodextrin Maltodextrin Skimmed Milk Powder
2 Whey Protein Concentrate Calcium Caseinate Caseinates (Milk Protein) Gum Acacia Fibre
3 Skimmed Milk Powder Vegetable Oils (High oleic sunflower oil, soy oil) Peanut Oil Soy Protein Isolate
4 Pea Protein Concentrate Fructose Fructose Maltodextrin
5 Flavours Fructo-oligosaccharides (5.28%) Inulin Corn Flour
6 Guar Gum Minerals Soya Protein Isolate Soya Fibre
7 Minerals Soy Polysaccharide (2.33%) Minerals Maize Starch
8 Vitamins Flavouring (Artificial Flavouring Substances) Salt Wheat Bran
9 Sucralose M-Inositol M-Inositol Edible Gum (Guar Gum)
10 Vitamins Choline Bitartrate Taurine
11 Taurine Vitamins Minerals
12 L-Carnitine L-Carnitine Vitamins
13 Anti-oxidants (mixed tocopherols) Taurine Nature Identical Flavouring Substances
14 Nature Identical Flavouring Substances

The nutritional values of the above samples were ascertained and the results are shown in Tables 3 and 4. As evident from Table 3 and Table 4, Market Samples 1 and 2 have a much higher amount of fat than the formulation of the present invention. Market Sample 3 has lesser fat but it contains higher amount of total sugars and lesser dietary fiber than the formulation of the present invention.

The formulation of the present invention contains no added sugar (sucrose), a high amount of dietary fiber (13.5g per serving), a very low fat (less than 1g per serving) and a high amount of protein (11.4g per serving).

The present invention provides a unique combination of nutrients which is not present in any of the market samples. Hence, this drink is suitable for the diabetic population as it contains no added sugars, high amount of dietary fiber and also is suitable for the cardiovascular patients for it contains very low levels of fat.

Table 3
Comparison of Nutrition Values* of Present Invention V/s Market Samples (Per 100g)*
Nutrients Formulation of the present invention Market Sample 1 Market Sample 2 Market Sample 3
Per 100g Per 100g Per 100g Per 100g
Energy (Kcal) 304 435 466 335
Fat (g) 2.6 14.6 19.8 1.1
Available Carbohydrates (g) 18.8 51.6 48.5 43.4
Total Sugars (g) 9.6 14.6 3.5 34.5
Sucrose/Sugar (g) 0 0 0 0
Dietary Fiber (g) 37.5 8.2 6.4 15.0
Protein (g) 31.6 20.1 20.0 30.0
*Approximate Values only.
Table 4
Comparison of Nutrition Values** of Present Invention V/s Market Samples (Per Serve)**

Nutrients Formulation of the present invention Market Sample 1 Market Sample 2 Market Sample 3
Per Serve (36g) Per Serve (52g) Per Serve (20g) Per Serve (25g)
Energy (Kcal) 109 227 94 84
Fat (g) 0.9 7.6 4.0 0.3
Available Carbohydrates (g) 6.8 26.8 9.7 10.9
Total Sugars (g) 3.5 7.6 0.7 8.6
Sucrose/Sugar (g) 0 0 0 0
Dietary Fiber (g) 13.5 4.3 1.3 3.8
Protein (g) 11.4 10.5 4.0 7.5
**Approximate Values only.
Sensory Study
Further sensory studies were conducted with the above formations.
Procedure of Sensory Evaluation:
Preparation of Four Comparative Samples:
1) The formulation of present invention was prepared by mixing 36g of powder in 200 ml of luke warm water, stirring and mixing till powder dissolves. Two such samples were prepared.
2) Market Sample 1 was prepared by gradually adding 52g of powder in 200 ml of water, stirring and mixing till powder dissolves. Two such samples were prepared.
3) Market Sample 2 was prepared by adding three level scoops (as provided in the pack) to 78 ml of water (previously boiled and cooled) and stirring till powder dissolves. Five such samples were prepared.
4) Market Sample 3 was prepared by adding 25g of powder to 200 ml of lukewarm milk and stirring it well. Two such samples were prepared.

Sensory Procedure:
1) All panelists were given similar quantities (50 ml each) of four samples and asked to rate whether each sample was acceptable from a sensory perspective (taste, after taste, mouth-feel, consistency, flavor, colour, appearance, aroma) or not. For each panelist, giving “UA” would mean that the product is un-acceptable from a sensory perspective and giving “A” would mean that the product is acceptable from a sensory perspective. Each “A” would mean 1 panelist has said that the product is acceptable whereas each “UA” would mean that the particular one panelist has not found the product to be acceptable. Each “A” would give 1 number in terms of acceptability. The higher the number in below table means a higher acceptability.
2) Each panelist were also asked to give the rank order preference as to which sample they preferred the most and which the least in terms of overall sensory characteristics. Ranking of 1 stands for best preferred whereas a ranking of 4 stands for least preferred.
3) All the individual panelists results were compiled together to arrive at the compiled results given in below table.
The sensory results are shown in Table 5. The below sensory scores in Table 5 prove that the formulated drink according to the present invention is acceptable as a product and even better than Market Sample 3.
Table 5
Sensory Panel Results (6 Expert Panelists)
Sensory Parameters Formulation of the present invention Market Sample 1 Market Sample 2 Market Sample 3
Rank order preference 3 2 1 4
Acceptability 3 3 6 2

Glycemic Study
The glycemic response of the formulation of the present invention, Market Sample 1, Market Sample 2, Market Sample 3 was tested on three human volunteers. The study was conducted for 4 consecutive days. On each day a single product was tested for its glycemic response. The procedure for testing the glycemic response of each product is given below -
· Volunteers were told to fast for 12 hours before the study.
· Preparation of Drink Samples:
o The formulation of the present invention was prepared by dissolving 36g of the powder in 200 ml of luke warm water. This is one serving of the formulation of the present invention which was administered.
o Market Samples 1, 2 and 3 were prepared exactly as per the instructions given on their packs and then administered. The brief of the instructions are mentioned below --
o Market Sample 1 was prepared by gradually adding 52g of powder in 200 ml of water, stirring and mixing till powder dissolves.
o Market Sample 2 was prepared by adding three level scoops (as provided in the pack) to 78 ml of water (previously boiled and cooled) and stirring till powder dissolves.
o Market Sample 3 was prepared by adding 25g of powder to 200 ml of lukewarm milk and stirring it well.
· The Initial blood glucose levels were taken for each of them post which they were administered a serving of the product.
· After every 15 minutes, blood glucose levels were taken for each of the volunteers till 1 hour period.
· Post 1 hour period, the blood glucose levels were taken every half hour till one hour.
· The results of the study are depicted in Figure 1.

As shown in Figure 1, on 15 minutes the formulation of the present invention gives a lower peak of blood glucose and hence a lower rise in blood glucose levels than Market Samples 1 and 3 whose peaks are much higher and give a higher rise in blood glucose levels. On 30 minutes the peak for the formulation of the present invention shows that the blood sugar level has dropped. But, in case of Market Sample 2 there is a rise in peak on 30 minutes which shows a rise in blood glucose levels. On 90 minutes, the formulation of the present invention had a lower peak than it had on 60 minutes which shows a decrease in blood glucose levels. On 90 minutes, Market Sample 3 shows a rise in the peak from 60 minutes. This shows an increase in blood glucose levels for Market Sample 3. This infers that on 90 minutes the blood sugar levels are going down more for formulation of the present invention as compared to Market Sample 3. Overall, the lowest fluctuations in blood glucose levels are observed in case of the formulation of the present invention. This infers that the formulation of the present invention has lowest glycemic response as compared to Market Samples 1, 2 and 3. This evidences that the present formulation is suitable to be consumed as a drink for the diabetics.

Example 3
Comparison between the glycemic response of the formulation disclosed in WO2009135959 and that of the present invention

The glycemic response of the present invention, whose composition is given in Table 7 below was determined and compared against the glycemic response given in WO2009135959 whose composition is given in Table 6.

Table 6 Table 7
Composition as per WO2009135959 Composition in accordance with the present invention

The glycemic response of both the above compositions is shown below in Figures 2 and 3. The glycemic response of formulation of the present invention (Figure 2) was found to be better than WO'959 (Figure 3) even without using oils/fats in the product. For the formulation of the present invention at 0 minutes the glucose level was 88 and its highest peak (99) is at 15 minutes after which it starts dropping down till 90 minutes. While that for WO'959 the glucose level at 0 minutes is about 90 which keeps peaking to above 100 till 30 minutes. So the increase in blood glucose happens till 30 minutes in WO'959 whereas in the present invention the increase is only till 15 minutes.

Example 4

Experiments were conducted varying the amounts of the components of the present invention to ascertain the criticality of the components.
The varying amounts are shown in Tables 8 and 9.
The present inventors have conducted a sensory evaluation which shows the criticality of the ratios in attaining an acceptable organoleptic profile.
Table 8
Sensory Panel Results (5 Expert Panelists)

Based on sensory results as shown in Table 8, Ratio's 4 to 8 were acceptable. The ratio's 6,7,8 contained lesser amount of glycemic response reducers as compared to ratio 4, 5 so blood sugar levels in them will rise more quickly than ratio 4, 5. Ratio's 6, 7, 8 were selected for a glycemic study.
Based on glycemic response as in evident in Figure 4, ratio 8 has been excluded as the blood glucose levels are again peaking at 60 minutes.

It was found that the composition of the present invention provided good glycemic response as well as acceptable organoleptic profile when the Component A was in amount 78.26% to 58.26% and component B is in amount 20.93% to 40.93% with the remaining (0.81%) being vitamins and minerals which can be filled up to get 100% (Table 9).

Table 9
Ratio's of Components and ingredient range