Glycemic Index of Diabetes Specific Nutrition Formulation (NUC-RDM)

Not yet recruiting

Conditions: Healthy participants with normal BMI

Registration Number: CTRI/2023/04/051530

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 hyper insulinemia, 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.

Aim: To measure glycemic index (GI) of diabetes specific nutrition formulation (NUC-RDM)

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Detailed Description: Not available

Recruitment & Eligibility

Status: Not Yet Recruiting

Sex: All

Target Recruitment: 15

Inclusion Criteria

Age 18 to 45 years BMI greater than equal to 18.5 to less than equal to 22.9 kg/ m2 (asper WHO cut off for normal BMI) Both male and female Willingness to consume the test foods no known food allergy or intolerance; no medications known to affect glucose tolerance (excluding oralcontraceptives) â€” stable doses of oral contraceptives, acetylsalicylicacid, thyroxin, vitamins and mineral supplements or drugs to treathypertension or osteoporosis are acceptable.

Exclusion Criteria

a known history of diabetes mellitus or the use of anti-hyperglycemicdrugs or insulin to treat diabetes and related conditions pregnant or lactating women a major medical or surgical event requiring hospitalization within thepreceding 3 months; the presence of disease or drug(s) which influence digestion andabsorption 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, Glycemic Response and GI category of food products	For both intervention and comparator agents capillary blood samples will be collected at -5,0 (fasting state) and at 15,30,45,60,90,120 mins from the first sip of test and reference foods. Testing of all foods will be done on separate days

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
044439688888
s2r_7@mdrf.in