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临床试验/CTRI/2023/09/057479
CTRI/2023/09/057479尚未招募不适用

Evaluation of Glycemic Index and impact on satiety of resistant malto dextrin enriched meal choices(aloo paratha and Idly)-A randomized cross over study

Madras Diabetes Research Foundation1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2023年9月20日最近更新:

试验速览

阶段
不适用
状态
尚未招募
入组人数
20
试验地点
1
主要终点
glycemic index, GI category of food preparations without & with dietary fibre enrichment

研究概览

简要总结

Research studies have shown thatlifestyle; in particular dietary aspects play an important role in preventing /increasing the burden of the chronic diseases. Dietary habits could thereforebe modified to exert a positive impact in the prevention and treatment. It hasbeen suggested that the high glycemic carbohydrate foods -those foodscontaining carbohydrates which elicit rapid blood glucose rise and therebyincrease the insulin demand leading to hyperinsulinemia, insulin resistance andtype 2 diabetes. Hence, there is a need to understand the blood glucose raisingpotential of foods in India to be of an important tool to aid in the preventionand or management of diabetes and its complication. Thus, evolved the conceptof ‘Glycemic Index’ (GI) which ranks the foods, based on the speed at which thefood raises the blood glucose in a scale of 0 to 100, 100 indicating highglycemic index corresponds to oral glucose’s GI. Today, India leading the worldwith the largest number of people with daibetes causing a heavy economic burdento the country urgently needs to look at cost effective strategies to combatthis situation. A cost-effective dietary approach like estimating andunderstanding the role of glycemic index of various Indian foods in thelifestyle related diseases like diabetes is urgently needed.

Incorporation of dietary fibre inhigh carbohydrate foods has been identified as a strategy to reduce theglycemic index of foods. Intake of dietary fibre increase stomach distension,which increases satiety and slows nutrient absorption. Furtherintake of dietary fibre can favorably influence the change in gut hormonelevels that act locally and, in the brain, to affect eating behavior. Ingestionof fibers like Fibersol®-2 increases peptide YY (PYY), which decreases appetiteby slowing gastric motility and inhibiting pancreatic secretion. It alsoincreases glucagon-like peptide-1 (GLP-1), which increases insulin secretionand sensitivity and inhibits gastric acid secretion and emptying, thusincreasing satiety signals in the brain. Hence, the present study was carriedout with the following objectives.

研究设计

研究类型
Interventional
分配方式
Random Number Table
盲法
Not Applicable

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 greater than 18.5 to less than 22.9 kg/ m2 (as per 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 oral contraceptives) — stable doses of oral contraceptives, acetylsalicylic acid, thyroxin, vitamins, fibre 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, prebiotics, and probiotics (all of which have major effects on glucose metabolism and body fat distribution) from past 30 days.
  • Regular use of supplements that are rich in dietary fiber or protein which influences the satiety assessment.

结局指标

主要结局

glycemic index, GI category of food preparations without & with dietary fibre enrichment

时间窗: Capillary blood samples will be collected at -5,0 minutes before consumption of test and reference foods and 15,30,45,60,90,120,180,240 minutes post consumption of test and reference foods

次要结局

  • The study will also elicit, the effect of the food preparations (aloo paratha & idly) without and with dietary fibre enrichment on satiety levels assessed using gut hormones-GLP-1 and PYY levels(Blood samples will be collected at 0 min (fasting), 60-, 120,180- & 240-minutes post consumption of intervention foods and 1 comparator glucose drink to assess selected gut hormones- GLP-1 and PYY)

研究者

申办方类型
Research institution

研究点 (1)

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