跳至主要内容
临床试验/CTRI/2021/04/033070
CTRI/2021/04/033070尚未招募不适用

Continuous glucose monitoring studies to evaluate the glycemic properties of a diet including health foods with lower glycemic index in elderly population with type 2 diabetes.

Department of Science Technology1 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5日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
15
试验地点
1
主要终点
This study will be a proof-of-concept study. The study findings will be considered to develop a health food kit for elderly population with diabetes

研究概览

简要总结

Age is an independent risk factor for non-communicable diseases such as diabetes andcardiovascular diseases. According to the census 2011 there are nearly 104 million elderly personin India. The ageing population faces numerous challenges like difficulty in food consumption(swallowing), dentures, physical inactivity, isolation from the family, financial constraints etc. Thereare plenty of health foods available in market for general population but specific food for elderlypopulation with diabetes especially convenience foods are almost nil. Due to physical inability many depend on home cooked meals and many a times lackof hygiene seems to be an issue. Hence, it is very important to develop convenience foods whichare easy to prepare and appropriate for old aged people with lower glycemic properties to suit theneeds of elderly with diabetes.Hence the current study is to assessthe effect of diet including newly developed health foods with lower glycemicindex in elderly population with diabetes compared to the control diet using continuousglucose monitoring (CGM) to examine the 24 h glycemic response.This study will be a proof-of-concept study and the findings will beconsidered to develop a health food kit for elderly population with diabetes.

研究设计

研究类型
Interventional
分配方式
Computer generated randomization
盲法
Participant Blinded

入排标准

年龄范围
60.00 Year(s) 至 99.00 Year(s)(—)
性别
All

入选标准

  • Age: 60 years and above 2)HbA1C values 7-11 3)Not on insulin 4)Willingness to consume the control and test diets 5)Without any major complications of diabetes.

排除标准

  • Self-report of any condition/illness that may affect the study outcomes or would make participation potentially harmful.
  • History of kidney disease.
  • Known food allergy 4)On chemotherapy 5)Difficulty to consume the study products.

结局指标

主要结局

This study will be a proof-of-concept study. The study findings will be considered to develop a health food kit for elderly population with diabetes

时间窗: 1 Year

次要结局

  • Comparison and assessment of changes in fasting blood glucose from baseline.(1 year)

研究者

发起方
Department of Science Technology
申办方类型
Government funding agency

研究点 (1)

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