Longitudinal Profiling of Gut Microbiome in Overweight or Obese Participants on a Modified Atkins Diet: a Prospective Cohort Study
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 75
- 试验地点
- 1
- 主要终点
- Dynamic changes of gut microbiome
研究概览
简要总结
The aim of the study is to investigate dynamic changes in biochemical metabolism, gut microbiome and its metabolites among overweight and obese participants while they are on a modified Atkins Diets.
详细描述
The mechanisms of obesity are complex, involved in genes, environment, life style, and systemic and adipose tissue inflammation. Dysbiosis of gut microbiome is considered to make a difference in obesity. On the other hand, both long-term and short-term dietary interventions can induce changes in the body composition and structure and function of gut microbiome. However, it is not really clear how gut microbiome changes along with weight loss in overweight or obese.
In the present study, investigators aim to characterize the gut microbiome among overweight or obese participants on a modified Atkins diets. The stool and blood samples were collected by an interval of every 5% and 10% of weight loss, respectively. Data collecting mainly covers: 1) body composition analysis ; 2) obesity related biochemical metabolism; 3) measurement of gut microbiome using metagenome and 16S rRNA sequencing techniques; 4) metabolomics of serum and gut microbiome; 5) measurement of physical activity and diets using questionnaires.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •18-55 years old;
- •BMI > 23.9kg/m2;
- •being willing and able to receive guidelines to a modified Atkins diet;
- •signed informed consent.
排除标准
- •patients with serious physical and mental diseases (including cardiovascular and cerebrovascular diseases, liver and kidney diseases, respiratory diseases gastrointestinal diseases, mental diseases, etc.);
- •patients with malignant tumor;
- •pregnant and lactating women;
- •those with recent relocation plans.
结局指标
主要结局
Dynamic changes of gut microbiome
时间窗: 36 months
The stool sample will be collected by an interval of each 5% weight loss that participants experienced. Fecal microbiota will be analyzed by 16S rRNA gene sequencing technique.
Dynamic changes in faecal metabolomics
时间窗: 36 months
For participants achieving each 10% weight loss, targeting metabonomics will be applied to identify the abundances of faecal metabolites (e.g. short-chain fatty acids, amino acids and carbohyrates) using validated mass spectrometry methods.
次要结局
- Dynamic changes of homocysteine(36 months)
- Dynamic changes of blood pressure(36 months)
- Dynamic changes of body mass index(36 months)
- Dynamic changes of body fat(36 months)
- Dynamic changes of muscle mass(36 months)
- Dynamic changes of blood lipids(36 months)
- Dynamic changes of fasting blood glucose(36 months)
研究者
Dan Yu, PhD
Principal investigator
Hebei Medical University Third Hospital