NCT04229082已完成不适用
Next Generation Probiotics (NGPs) for Metabolic Health - Metagenomic Analysis to Identify NGP Candidates Correlated With Body Weight or Metabolic Markers
Danisco0 个研究点目标入组 100 人开始时间: 2016年4月8日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 100
- 主要终点
- evaluate the differences in the intestinal microbiota profile between lean and obese subjects.
研究概览
简要总结
To identify differences in the intestinal microbiota by metagenomics analyses between lean and obese subjects
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 20 Years 至 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Age between 20 to 50 years.
- •Obtained his/her informed consent after verbal and written information.
- •Sufficient general health and orientation for participating in the study as evaluated by the study personnel.
- •Have a high probability for compliance with and completion of the study.
- •Available for study visits and availability for food
- •Normal gastrointestinal function.
- •Willingness to provide faecal, urine and blood samples and keep food diary
排除标准
- •Lactobacillus Rhamnosus GG or reuteri, bifidobacteria enriched products) in the past 6 weeks.
- •Use of anti-obesity drugs.
- •Active or recent (last 3 months) participation in a weight loss program including weight change (increase or loss) of 3 kg during the past three months.
- •Special diets e.g. Vegetarian, Vegan, Diets with intention to use certain limited food groups only (like paleo diet, egg-grape diet etc.)
- •History of chronic active inflammatory disorders.
- •History of bariatric surgery.
- •Regular use of non-steroidal anti-inflammatory drugs, corticosteroids, or equivalent immunomodulatory drugs.
- •Ongoing or recent (last 3 months) antibiotic treatment.
- •Immunosuppression or ongoing therapy causing immunosuppression.
- •Use of vitamin supplementations beyond Recommended Daily Intake levels during the previous 2 months and during the study, except for vitamin D supplementation up to 20 μg/day.
结局指标
主要结局
evaluate the differences in the intestinal microbiota profile between lean and obese subjects.
时间窗: 1 week
次要结局
未报告次要终点
研究者
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