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临床试验/CTRI/2023/10/059332
CTRI/2023/10/059332已完成4 期

A COMPREHENSIVE STUDY TO ESTABLISH THE HEALTH BENEFITS (IN-VIVO)OF NUTRI-CEREALS" A WAY FORWARD FOR MAINSTREAMING MILLETS

Ministry of Agriculture and Farmers Welfare1 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2023年11月15日最近更新:

试验速览

阶段
4 期
状态
已完成
发起方
入组人数
120
试验地点
1
主要终点
The effect of finger millet supplementation on appetite hormones would be known.

研究概览

简要总结

Millets are rich source of slow digesting carbohydrates, minerals, dietary fibre, essential fatty acids and B-complex vitamins and minerals. Millets have numerous health benefits due to their nutritional composition. Apart from its nutraceutical properties, studies have highlighted its role in gut health and in immune response modulation. However, the nutritional and health benefits of millets have not been explored in athletic population. Hence, the preliminary exploratory study will attempt to  examine effect of millets on appetite hormones, micronutrient status, gut health, immunomodulation, physiological and cognitive performance in athletes.

A randomised controlled trial will be conducted to compare the efficacy of Finger millet on appetite hormones and cognitive performance in athletes  (Study-I; n=60)  and efficacy of pearl millet on micronutrient status, gut health, immunomodulation, physiological and cognitive performance in athletes  (Study -II; n=60). Baseline information such as socio-demographic profile, anthropometry, 3 days dietary intake and activity recording will be done. Biochemical and performance tests will be conducted. Information on cognitive performance will be collected. Based on the baseline information, the athletes will be randomly assigned to the experimental group (n=30) and to the control group (n=30). Finger millet or pearl millet products (1/3rd of the daily cereals will be given to experimental group and rice /wheat-based diet to the control group. athletes for 60 days. End line information will be collected following the similar procedures of baseline on anthropometry, nutrient intake, biochemical tests, cognitive and physical performance.

研究设计

研究类型
Interventional
分配方式
Computer generated randomization
盲法
Open Label

入排标准

年龄范围
18.00 Year(s) 至 25.00 Year(s)(—)
性别
Male

入选标准

  • The inclusion criteria will be competitive athletes in the age between 18-25yrs, general good health and a willingness to either follow the trial guidelines (eg, avoid potentially conflicting nutritional or vitamin supplements) or provide notification of compliance.

排除标准

  • Consumption of millets, alcohol, smokers, any recent history of acute or chronic debilitating illness, medication, consumption of dietary supplements and ergogenic aids, physical disabilities, presence of sports injuries.

结局指标

主要结局

The effect of finger millet supplementation on appetite hormones would be known.

时间窗: Baseline and after 2 months

Information on the effect of pearl millet in context to serum micronutrient status, gut health and immune-modulating factors in athletes would be known.

时间窗: Baseline and after 2 months

The effect of pearl millet on physiological would be known.

时间窗: Baseline and after 2 months

次要结局

  • The effect of pearl millet and finger millet on cognitive performance would be known.(Baseline and after 2 months)

研究者

发起方
Ministry of Agriculture and Farmers Welfare
申办方类型
Government funding agency

研究点 (1)

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