Longitudinal Profiling of Gut Microbiome in Overweight or Obese Participants on a Modified Atkins Diet: a Prospective Cohort Study
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Overweight or Obesity
- Sponsor
- Hebei Medical University Third Hospital
- Enrollment
- 75
- Locations
- 1
- Primary Endpoint
- Dynamic changes of gut microbiome
- Last Updated
- 4 years ago
Overview
Brief Summary
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.
Detailed Description
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.
Investigators
Dan Yu, PhD
Principal investigator
Hebei Medical University Third Hospital
Eligibility Criteria
Inclusion Criteria
- •18-55 years old;
- •BMI \> 23.9kg/m2;
- •being willing and able to receive guidelines to a modified Atkins diet;
- •signed informed consent.
Exclusion Criteria
- •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.
Outcomes
Primary Outcomes
Dynamic changes of gut microbiome
Time Frame: 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
Time Frame: 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.
Secondary Outcomes
- 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)