Modified Atkins Diet for Overweight and Obesity

• Conditions: Overweight or Obesity

• Registration Number: NCT04207879
• Lead Sponsor: Hebei Medical University Third Hospital

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.

Study Timeline

• Study First Submitted: 2019-12-04
• Study First Submitted QC: 2019-12-18
• Study First Posted: 2019-12-23
• Study Start: 2020-01-01
• Status Verified: 2022-01
• Primary Completion: 2022-01-01
• Last Update Submitted: 2022-01-19
• Last Update Posted: 2022-01-20
• Study Completion: 2023-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 75

Inclusion Criteria

1. 18-55 years old;
2. BMI > 23.9kg/m2;
3. being willing and able to receive guidelines to a modified Atkins diet;
4. signed informed consent.

Exclusion Criteria

1. patients with serious physical and mental diseases (including cardiovascular and cerebrovascular diseases, liver and kidney diseases, respiratory diseases gastrointestinal diseases, mental diseases, etc.);
2. patients with malignant tumor;
3. pregnant and lactating women;
4. those with recent relocation plans.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Dynamic changes of gut microbiome	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	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 Outcome Measures

Name	Time	Method
Dynamic changes of homocysteine	36 months	For participants achieving each 10% weight loss, intravenous serum will be collected and homocysteine will be measured by automatic biochemical analyzer.
Dynamic changes of blood pressure	36 months	For participants achieving each 10% weight loss, blood pressure will be measured by the standard electronic sphygmomanometer.
Dynamic changes of body mass index	36 months	Weight and height will be combined to report BMI in kg/m\^2.
Dynamic changes of body fat	36 months	As a body composition parameter, body fat will be analyzed by body composition automatic analyzer for each participant every 10-20 days.
Dynamic changes of muscle mass	36 months	Muscle mass will be analyzed by body composition automatic analyzer for each participant every 10-20 days.
Dynamic changes of blood lipids	36 months	For participants achieving each 10% weight loss, intravenous serum will be collected and the parameters which can reflect the lipids metalism (such as triglyceride, total cholesterol, low density lipoprotein cholesterol, high density lipoprotein cholesterol ) will be measured by automatic biochemical analyzer.
Dynamic changes of fasting blood glucose	36 months	For participants achieving each 10% weight loss, intravenous serum will be collected and fasting blood glucose will be measured by automatic biochemical analyzer.

Trial Locations

Locations (1)

Hebei Medical University Third Hospital; 🇨🇳 Shijiazhuang, Hebei, China