Glycemic index testing of beverage-meal replacement and a herbal paste

Not yet recruiting

Conditions: Healthy human participants with normal body mass index and free of disease

Registration Number: CTRI/2022/08/044890

Lead Sponsor: Madras Diabetes Research Foundation

Brief Summary: Research studies have shown that lifestyle; in particular dietary aspects play an important role in preventing / increasing the burden of the chronic diseases. Dietary habits could therefore be modified to exert a positive impact in the prevention and treatment. It has been suggested that the high glycemic carbohydrate foods -those foods containing carbohydrates which elicit rapid blood glucose rise and thereby increase the insulin demand leading to hyperinsulinemia, insulin resistance and type 2 diabetes. Hence, there is a need to understand the blood glucose raising potential of foods in India to be of an important tool to aid in the prevention and or management of diabetes and its complication. Thus, evolved the concept of â€˜Glycemic Indexâ€™ (GI) which ranks the foods, based on the speed at which the food raises the blood glucose in a scale of 0 to 100, 100 indicating high glycemic index corresponds to oral glucoseâ€™s GI. Today, India leading the world with the largest number of diabetic volunteers causing a heavy economic burden to the country urgently needs to look at cost effective strategies to combat this situation. A cost-effective dietary approach like estimating and understanding the role of glycemic index of various Indian foods in the lifestyle related diseases like diabetes is urgently needed.

Detailed Description: Not available

Recruitment & Eligibility

Status: Not Yet Recruiting

Sex: All

Target Recruitment: 15

Inclusion Criteria

BMI more than 18.5 to less than 22.9 kg/ m2 (as per WHO cut off for normal BMI) Willingness to consume the test foods no known food allergy or intolerance; no medications known to affect glucose tolerance (excluding oral contraceptives) â€” stable doses of oral contraceptives, acetylsalicylic acid, thyroxin, vitamins and mineral supplements or drugs to treat hypertension or osteoporosis are acceptable.

Exclusion Criteria

a known history of diabetes mellitus or the use of anti-hyperglycemic drugs or insulin to treat diabetes and related conditions pregnant or lactating women a major medical or surgical event requiring hospitalization within the preceding 3 months; the presence of disease or drug(s) which influence digestion and absorption of nutrients; the use of steroids, protease inhibitors or antipsychotics (all of which have major effects on glucose metabolism and body fat distribution).

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Glycemic index and response of meal replacements and herbal paste compared to reference glucose	Capillary blood samples will be collected at 0 min- fasting and 4 times at an interval of 15 mins-15,30,45,60 mins and 2 times at interval of half an hour-90 and 120 mins for each test and reference food to determine the glycemic index.

Secondary Outcome Measures

Name	Time	Method

Trial Locations

Locations (1): Madras Diabetes Research Foundation
🇮🇳
Chennai, TAMIL NADU, India
Madras Diabetes Research Foundation
🇮🇳Chennai, TAMIL NADU, India
Mrs Sudha Vasudevan
Principal investigator
9840014480
s2r_7@mdrf.in