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临床试验/CTRI/2026/01/100664
CTRI/2026/01/100664招募中不适用

Clinical evaluation of glycemic response, insulinemic response and satiety of plant-based diabetic-friendly Indian traditional mixed meals in overweight/obese women in India

Sri Sathya Sai Institute of Higher Learning1 个研究点 分布在 1 个国家目标入组 12 人开始时间: 2026年2月2日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
12
试验地点
1
主要终点
Effect of plant-based reformulated diabetic friendly Indian traditional mixed meals on Glycemic response and insulinemic responses will be known

研究概览

简要总结

Diabetes mellitus is a major public health problem worldwide affecting millions of people which is essentially due to dramatic changes in diet and lifestyle. It is a chronic disorder occurring due to elevated blood glucose levels and the inability of a body’s response to high blood glucose, which is caused by defects in insulin secretion and action. One of the major aims of chronic disease therapy is to normalize the blood glucose profile, including the fasting and postprandial blood glucose concentrations. Many carbohydrate foods provoke variable glycemic responses. Assessment of glycemic response is one of the effective methods to compare between various meal types.  Low glycemic foods and diets have been shown to improve glycemic control in diabetics and in non-diabetic subjects. The purpose of this study is to evaluate the glycemic and response, insulinemic response and satiety of plant-based diabetic-friendly Indian traditional mixed meals in overweight/obese women. The impact of mixed meals on the post prandial blood glucose response will be determined using finger prick capillary method (Hemocue 201) at 0, 30, 60, 90, 120 minutes. Intravenous blood will be collected to measure the fasting and post-prandial insulin levels. Satiety of the meals will also be evaluated using SLIM scale. Glycemic and insulinemic responses of reformulated traditional meals with diabetic-friendly ingredients will be known from the study results. Better control of diabetes and other lifestyle disorders expected, when results are shared with the general public.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Participant and Outcome Assessor Blinded

入排标准

年龄范围
18.00 Year(s) 至 30.00 Year(s)(—)
性别
Female

入选标准

  • BMI: 23.5-30 kg/m
  • Overweight/Obese individuals.
  • Fasting blood glucose: 70-100 mg/dl.
  • Freely consented to participate in the study.

排除标准

  • Subjects taking medication known to modify glucose metabolism.
  • Subjects suffering from any illness or food allergies.
  • Subjects with consumption of any appetite suppressants, weight loss medication, or any other medication that could influence study outcomes.

结局指标

主要结局

Effect of plant-based reformulated diabetic friendly Indian traditional mixed meals on Glycemic response and insulinemic responses will be known

时间窗: Finger prick capillary blood samples will be taken before consumption of the meals, followed by testing every 30 minutes for the next two hours. Intravenous blood will be collected to measure the fasting and post-prandial insulin levels

次要结局

  • Effect of plant-based reformulated diabetic friendly Indian traditional mixed meals on satiety will be known(Participants will be given 20 minutes to complete the meal. Outcome is measured at 0, 10 & 20 minutes.)

研究者

申办方类型
Other [Educational Institution (Deemed to be University)]
责任方
Principal Investigator
主要研究者

Srividya Nagarajan

Sri Sathya Sai Institute of Higher Learning (Deemed to be University)

研究点 (1)

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