Effect of a Health drink on 2 hours Glucose Response among Normal Individuals
- Conditions
- Male and female normal individuals (BMIless than or equal to 22.9)
- Registration Number
- CTRI/2021/01/030412
- Lead Sponsor
- ModiMundipharma Pvt Ltd
- 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 ‘Glycemic Index’ (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 glucose’s GI. Today, India leading the world with
the largest number of diabetic volunteers causing a heavy economic burden to the country urgently
need to look at cost effective strategies to combat this situation. A cost effective dietary approach
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REF/2018/03/018745
CTRI Website URL - http://ctri.nic.in
like estimating and understanding the role of glycemic index of various Indian foods in the lifestyle
related diseases like diabetes is urgently needed. Capillary blood glucose will be measured at 0, 15,
30, 45, 60, 90 and 120 min using Hemocue Glucose 201+ analyzer (Hemocue®Ltd, Angelholm,
Sweden). Standard glucose drink will be given for 3 different days to get average glucose response
and each test food for 1 day with a wash out period of 2 to 3 days between each test day. The GI
was calculated as IAUC of test food/IAUC of reference (Glucose) food x 100.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Not Yet Recruiting
- Sex
- All
- Target Recruitment
- 15
BMI ≤ 22.9 kg/ m2 Willingness to consume the test foods no known food allergy or intolerance; no medications known to affect glucose tolerance (excluding oral contraceptives) — stable doses of oral contraceptives, acetylsalicylic acid, thyroxin, vitamins and mineral supplements or drugs to treat hypertension or osteoporosis are acceptable.
a known history of diabetes mellitus or the use of anti-hyperglycaemic 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 The study will elicit the glycemic index, GI category vanilla flavored vidavance drink. Capillary glucose will be assessed 8 times on each test day(2 times in fasting and 15,30,45,60,90,120 mins post consumption of test and reference food on 2 separate occasions.
- Secondary Outcome Measures
Name Time Method Assessing the proximates and available carbohydrates of food products
Trial Locations
- Locations (1)
MADRAS DIABETES RESEARCH FOUNDATION
🇮🇳Chennai, TAMIL NADU, India
MADRAS DIABETES RESEARCH FOUNDATION🇮🇳Chennai, TAMIL NADU, IndiaMrs Sudha VasudevanPrincipal investigator9840014480s2r_7@mdrf.in