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临床试验/CTRI/2021/03/032032
CTRI/2021/03/032032尚未招募不适用

"Evaluation of Glycemic Index of high protein high fibre biscuits"

Madras Diabetes Research Foundation1 个研究点 分布在 1 个国家目标入组 15 人开始时间: 2021年3月18日最近更新:

试验速览

阶段
不适用
状态
尚未招募
入组人数
15
试验地点
1
主要终点
Assessing the glycemic index, GI category of high protein high fibre biscuits

研究概览

简要总结

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

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.

研究设计

研究类型
Interventional
分配方式
Other
盲法
Open Label

入排标准

年龄范围
18.00 Year(s) 至 45.00 Year(s)(—)
性别
All

入选标准

  • BMI ≤ 22.9 kg/ m
  • 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.

排除标准

  • 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).

结局指标

主要结局

Assessing the glycemic index, GI category of high protein high fibre biscuits

时间窗: 3 months

次要结局

  • Assessing the proximates and available(carbohydrates of food products)

研究者

申办方类型
Other [Non-profit research institute]

研究点 (1)

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