According to American Association of Diabetes Educators nearly 200 million people suffer from this killer disease all over the world.60 new cases are diagnosed every 5mins,about 30 people die of the consequences of diabetes every day & the numbers are on a continuous rise. Diet therapy is an essential component of successful diabetes management (Jenkins et al., 1978). Diabetics need to break their per day calorie consumption in small parts for better maintenance of their blood glucose level so that it doesn’t reach a peak or a valley but stays at a safe plateau level. The three big meals i.e. breakfast, lunch & dinner generally comprise of homemade, the calorie content not going overboard according to the doctor’s instruction.So, these major meals disturbing the blood glucose level is ruled out, per se (Simpson et al.,1981).

India generally ‘snacks’ translate to traditional ‘oily samosas, bhajiyas, farsan, vada, bhelpuri etc.’, which are a powerhouse of calories. The general notion is that something which is not sweet,is safe for consumption. In India, very few people are diet conscious, and despite their desire to remain healthy, do not eat in ‘calorie-limits’. Just a piece of snack disturbs the otherwise well maintained blood-glucose level, leading to severe consequences in future. 

1 Results and analysis
1.1 Descriptive statistical analysis of the preliminary survey data
On the basis of literature and doctors’ survey, it can be recommended that a diabetic should consume 5~6 meals in a day including 3 major and 2~3 minor meals. The total calorie content of major meal should be around 600 kcal and for minor meal about 150~200 kcal (for individuals with moderate work). The time gap between subsequent meals should be around 3 hours.

According to the analysed data all 40 subjects consumed 3 major meals in a day i.e. breakfast, lunch, dinner, which is appropriate as per the medical guidelines. Most subjects i.e. 37 consumed only 1 minor meal in a day, 2 subjects consumed 2 minor meals whereas 1 subject didn’t consume any minor meal at all. This approach is not appropriate as per medical guidelines and the recommended intake is 2~3 meals consisting of 150~200 kcal per meal. The data regarding time gap between meals was compiled and analysed to find how well the subjects were under the specified medical guidelines. From Figure 1 it can be seen that as majority of the subjects i.e. 37 didn’t consume the morning mid-day meal, the time gap was of around 4~5 hours, which was inappropriate for maintaining the blood glucose level and ultimately would lead to diabetic complications in the long run.

 

Figure 1 The time gap between meals consumed in a day

Palate preference -32 out of 40 subjects preferred a spicy taste in their mid-day meal and rest 8 preferred sweet taste. This data was further statistically analysed at a specified confidence level so that the product could be formulated on the obtained conclusions (Table 1).
 

Table 1 Analysis of the collected data using Chi-square distribution

It was observed that the calculated χ 2 value i.e. 14.4 was significantly greater than the tabular χ 2 values of 3.84 and 6.63 (p<0.05 and p<0.01)It indicated that the palate preference for spicy taste was more than sweet taste, hence formulation of the proposed product was thus carried out on these lines.

1.2 Analysis of clinical trials
The means of the individual blood glucose level types i.e. FBS and PP2 were calculated and were compared with the pre-laid safe ranges. The data of mean blood glucose levels of subjects is given in Table 2. It can be observed that the results for mean blood-glucose levels of the 40 control subjects were almost in accordance with the pre-laid limits. The subjects not being under 24-hour monitoring for the clinical trial, some discrepancy was expected in their diet intake, though each individual was given specified instructions and their diet intake was asked to be noted down in the personal forms provided, for each day.
 

Table 2 Mean blood glucose levels of subjects

The results of paired T test for the blood glucose levels of subjects are given in Table 3. There was no significant difference between the fasting blood glucose levels (FBS_D1, FBS_D2, FBS_D3, FBS_D4). This meant that the subjects were in control of their blood sugar levels and hence eligible for the trials and also the result analysis.
 

Table 3 Comparison of observed mean blood glucose levels of subjects

There was no significant difference between the PP2 BS levels of day 3 and day 4 which means that the subjects had constant blood glucose levels on both the days with formulated snack. However there was a significant difference (30 mg/dl negative shift) between the PP2BS levels of subjects when they consumed their regular meal in comparison with the formulated snack.

1.3 Response of the formulated snack
All variants of the snack were found to be successful in lowering the blood glucose levels of the subjects which is indicated by clinical trial analysis. This showed that the formulated RTS convenience snack had a very high probability of having a low glycemic index compared to the fried snacks available in the market. An oral response from the subjects showed that the snack had satiety of almost 2 hours (Table 4).
 

Table 4 Validation of the product (nutritional analysis)

2 Conclusions
From the present investigation, it can be concluded that there was a significant drop in the blood glucose levels of the subjects after they consumed the formulated snack i.e. around 30 mg/dl. Validation tests showed that the calorie content of 1 serving (40 g) was well under recommended guidelines i.e. 175 kcal. The nutritional value obtained based on a 2 000 kcal diet was satisfactory (19% protein requirement fulfilled) and there were no traces of trans fat or cholesterol.

3 Materials and Methods
3.1 Pre-project Surveys: Doctors and Patients
A questionnaire was designed to take the hands-on view of doctors on diet therapy. Five physicians were consulted and with the help of their feed-back combined with the excerpts from the literature reviewed, the consumer questionnaire was designed. The consumer survey was conducted on 40 subjects in a randomized way. Each subject was personally explained the questionnaire in detail and also the medical aspect behind it. For the people who couldn’t comprehend “English”, the questionnaire was translated in their mother tongue to avoid any ambiguity. These age groups were surveyed: Juvenile diabetics (under the age of 14, insulin dependent), Maturity on-set diabetes of young (between 20~35yrs, IDDM/NIDDM), Maturity on-set diabetes of old (35 yrs and above, IDDM/NIDDM). These economic strata were surveyed: Low income group (earning Rs 1 500~5 000/month), Middle income group (earning Rs 5 000~20 000/month), Higher income group (earning Rs 20000 and above/month) (Masharani, 2011).

3.2  Clinical trials
For the clinical trials (pertaining to diabetes) (Mohan et al., 2011), the efficacy of any product is measured via obtaining the post prandial (2 hours) blood glucose level samples. Forty subjects were asked to consume their regular mid-day meal and then their post-prandial (2 hours) blood glucose level samples were measured (POD-GOD Method, ERBACHEM-7). A gap of at least 2 days was given and the next blood samples were collected. In the following week they were asked to consume their regular meals but instead of their mid-day snack they were administered with the ‘formulated product’ and again the same procedure was repeated. The fasting blood glucose levels on all the days were measured (Sicree et al., 2006). The almost constant fasting blood glucose levels proved that the subject was in control of his sugar levels and hence eligible for the trials. The subjects were provided with a daily diet intake form (in the local language, Gujarati as well) for maintaining a record of their calorie consumption to keep the clinical trial under the specified bounds. The results of all subjects were tabulated and the results were analysed using Paired t-test.

3.3 Formulation of the snack
According to the American Dietetic Association (http://www.eatright.org) any meal consumed by a diabetic should contain the following calorie distribution: 55% carbohydrates, 30% fat and 20% protein. Out of the different classes of food products studied, legumes and pulses (Pathak et al., 2000) were found to have the least Glycemic Index (GI) and possessed an appreciable amount of protein and dietary fiber. Peanuts were also added (if eaten in the prescribed amount of calorie content, pose as a potential ingredient). The following combination of food stuffs were selected, based on their nutritional content, glycemic index and palatability (Table 5). The average Indian palate relates to mixurechewadachawana (traditional Indian snack) with puffed rice, hence puffed rice was selected in spite of high G.I. value for the mental satiation of the diabetic individual (Murugesan et al., 2007).
 

Table 5 Glycemic index of selected ingredients

The spice mix (containing flax seed, helps in lowering blood glucose level) was coated on the roasted ingredients using an olive oil spray (aerosol). The product being a mid-day RTS convenience snack had a weight of approximately 40g (one serving according to consumer acceptability and in accordance with the other convenience snacks available in the market). The formulations of different ingredients used are shown in table 6.
 

Table 6 Formulations of mid day snack for a diabetics

3.4 Statistical analysis
The Survey data of 40 subjects were analysed by using descriptive statistics (Johnson, 1999), and inferential statistical analysis was used for the formulation of the palate preference (taste) of the product using CHI square test. The paired t-test (calculated via the SSPS-20 software for Windows, SPSS Inc., Chicago, IL) was used to compare any change in the blood glucose levels of the subjects due to administered snack.

3.5 Validation of the product
The nutritional analysis was carried out using certified test parameters. % Carbohydrate [IS:2234: 1989, ref. 2005], % Crude fibre and % Oil (ether extract) [IS:12711:1989, ref.2005], % Protein (on dry matter basis) [IS: 7219:1973, ref.2005], % Total MUFA, % Total PUFA, % Total saturated fatty acid, % Total sugar(reducing+non-reducing) and % Trans fat [AOAC 963.22 17th ed.], Calories kcal/100g [FAO paper 77 2003], Cholesterol mg/kg [NIN Manual].

Acknowledgements
The authors are highly indebted to Dr.K.D.Balchandani and Dr.R.K.Jain for guiding them at crucial points during the entire project, Vishal laboratory for carrying out the requisite blood tests at specified time intervals, Rasayan lab for effectuating the nutritional analysis and the patients for their endless cooperation.

References
Clark C.A., Gardiner J., McBurney M.I., Anderson S., Weatherspoon L.J., Henry D.N., and Hord N.G., 2006, Effects of breakfast meal composition on second meal metabolic responses in adults with type 2 diabetes mellitus, European J of Clinical Nutrition, 60(9): 1122-1129  http://dx.doi.org/10.1038/sj.ejcn.1602427  PMid: 16670695 
 
Jenkins D.J., Wolever T.M., Nineham R., Taylor R., Metz G.L., Bacon S., and Hockaday T.D., 1978, Guar crispbread in the diabetic diet., BMJ, 2(6154): 1744-1746 http://dx.doi.org/10.1136/bmj.2.6154.1744 PMid: 737474 PMCid: 1609996
 
Johnson R.A., ed., 1999, Miller and freund's probability and statistics for engineers 6th, Prentice Hall, Lebanon, Indiana, U.S.A., pp.30-35
 
Masharani U., ed., 2011, Diabetes mellitus & hypoglycemia: Ch 27, Current Medical Diagnosis Treatment, 15th, pp.1140-1145 
 
Mohan V., Unnikrishnan R., and Anjana R.M., eds., 2011, Dr. Mohan's Handbook of diabetes mellitus 4th, pp. 21-25 
 
Murugesan N., Snehalatha C., Shobhana R., Roglic G., and Ramachandran A., 2007, Awareness, about diabetes and its complications in the general and diabetic population in a city in southern India, Diabetes Res. Clin. Pract., 77(3): 433-447
http://dx.doi.org/10.1016/j.diabres.2007.01.004 PMid: 17291622 
 
Pathak P., Srivastava S., and Grover S., 2000, Development of food products based on millets, legumes and fenugreek seeds and their suitability in the diabetic diet, Int. J. Food Sci. Nutr., 51(5): 409-414 http://dx.doi.org/10.1080/096374800427019
PMid: 11103307 
 
Pendsey S., ed., 2002, Practical management of diabetes.2nd, Jaypee Publishers, New Delhi, pp.65-90
 
Sicree R., Shaw J., and Zimmet P., eds., 2006, Diabetes and impaired glucose tolerance in India, International Diabetes Federation, Belgium, pp.15-103
 
Simpson H.C.R., Lousley S., Geekie M., Simpson R.W., Carter R.D., Hockaday T.D.R., and Mann J.I., 1981, A high carbohydrate leguminous diet improves all aspects of diabetes control, The Lancet, 317(8210): 1-5 http://dx.doi.org/10.1016/S0140-6736(81)90112-4