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临床试验/CTRI/2023/04/051530
CTRI/2023/04/051530尚未招募不适用

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

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: 2023年4月25日最近更新:
适应症

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
Glycemic index, Glycemic Response and GI category of food products

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 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 ‘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 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)

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

  • •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) — stable doses of oral contraceptives, acetylsalicylicacid, thyroxin, vitamins and mineral supplements or drugs to treathypertension or osteoporosis are acceptable.

排除标准

  • •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).

结局指标

主要结局

Glycemic index, Glycemic Response and GI category of food products

时间窗: 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

次要结局

未报告次要终点

研究者

申办方类型
Research institution

研究点 (1)

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