Dynamics of Gut Microbiome in Overweight or Obese Participants on a Modified Atkins Diet

NCT ID: NCT07212556

Last Updated: 2025-10-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Study Classification

OBSERVATIONAL

Study Start Date

2019-10-31

Study Completion Date

2025-11-30

Brief Summary

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The aim of the study is to investigate dynamic changes in gut microbiome and its metabolites among overweight and obese participants while they are on a modified Atkins Diets.

Detailed Description

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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, we 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) measurement of gut microbiome using metagenome and 16S rRNA sequencing techniques; 2) metabolomics of serum and gut microbiome; 3) measurement of physical activity and diets using questionnaires.

Conditions

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Overweight or Obesity

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Hebei Medical University Third Hospital

OTHER

Sponsor Role collaborator

Westlake University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Ju-Sheng Zheng, PhD

Role: PRINCIPAL_INVESTIGATOR

Westlake University

Locations

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The third hospital of Hebei medical university

Shijiazhuang, Hebei, China

Site Status

Countries

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China

Other Identifiers

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20190901ZJS0012

Identifier Type: -

Identifier Source: org_study_id

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