Clinical validation of traditional millet recipes (roti/dosa/khichidi) in maintaining healthy intestinal microbial flora and preventing lifestyle associated complications
试验速览
- 阶段
- Unknown
- 状态
- 进行中（未招募）
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- All participants will be subjected to analysis of changes in following biomarkers in blood sample analysis before and after millet intake-
研究概览
简要总结
This project aims to scientifically validate the health benefits of traditional millet-based recipes in light of their potential to combat lifestyle diseases and micronutrient deficiencies, which are prevalent public health concerns globally. Recognizing the nutritional value of millets, which are gluten-free, low in glycemic index, and rich in both macro and micro-nutrients, this study proposes a clinical validation through a clinical trial with human volunteers. The objectives include selecting volunteers post-ethical clearance, preparing and analyzing the nutritional content of millet-based breakfast recipes, collecting and analyzing blood samples for markers of lifestyle diseases, and examining the gut microflora through 16-srRNA sequencing. This comprehensive approach aims to promote millets as a dietary option for preventing and managing conditions like diabetes, obesity, and cardiovascular diseases, leveraging their historical consumption dating back to 1500 BC in India and their resurgence in modern diets worldwide.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 盲法
- None
入排标准
- 年龄范围
- 20.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •Group 1: Healthy volunteers -Normal (without type II diabetes mellitus (TY2DM), Cardiovascular Disease (CVD)/hypertension, Non-alcoholic fatty liver disease (NAFLD) /hyperlipidemia), Volunteers with following conditions: Group 2: type II diabetes mellitus (TY2DM)/prediabetes, Group 3: Cardiovascular Disease (CVD)/hypertension, Group 4: Non-alcoholic fatty liver disease (NAFLD) /hyperlipidemia) will be included in this study.
- •The participants who are on medications for the above conditions will also be included.
排除标准
- •People with severe illnesses, People already on a millet diet, Those with gastrointestinal symptoms and/or gastrointestinal diseases, Pregnant or lactating females and Those who have recently (past month) used antibiotics will be excluded from this study.
结局指标
主要结局
All participants will be subjected to analysis of changes in following biomarkers in blood sample analysis before and after millet intake-
时间窗: First and last day of the 3 months period of millet diet.
Diabetic/ prediabetic markers (Fasting Blood Sugar)
时间窗: First and last day of the 3 months period of millet diet.
CVD biomarkers (complete lipid profile, adiponectin, C-Reactive Protein, Angiotensin Converting Enzyme activity)
时间窗: First and last day of the 3 months period of millet diet.
Hepatic functions (Aspartate aminotransferase, Alanine transaminase, Alkaline phosphatase, Albumin, Bilirubin, Total protein, Gamma glutamyl transferase)
时间窗: First and last day of the 3 months period of millet diet.
Analysis of the gut microflora by 16S rRNA sequencing of stool samples before and after the millet intake
时间窗: First and last day of the 3 months period of millet diet.
次要结局
- Beneficial effects of millets on the gut microbiome as evidenced by increase in gut microflora.
研究者
Dr Priya S
CSIR National Institute for Interdisciplinary Science and Technology