Modified Atkins Diet for Overweight and Obesity

January 19, 2022 updated by: Dan Yu, PhD, Hebei Medical University Third Hospital

Longitudinal Profiling of Gut Microbiome in Overweight or Obese Participants on a Modified Atkins Diet: a Prospective Cohort Study

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.

Study Overview

Status

Active, not recruiting

Conditions

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 Type

Observational

Enrollment (Actual)

75

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Hebei
      • Shijiazhuang, Hebei, China, 050051
        • Hebei Medical University Third Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 55 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

The study is conducted in Shijiazhuang, a city in Northen China. Eligible participants are residents in this area and aged 18-55 years old, who are on a modified Atkins diet aiming to lose weight.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
weight loss group
Dynamic changes in body composition, biochemical metabolomics and gut microbiome will be reported among overweight and obese patients.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
36 months
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.
36 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Dynamic changes of body mass index
Time Frame: 36 months
Weight and height will be combined to report BMI in kg/m^2.
36 months
Dynamic changes of body fat
Time Frame: 36 months
As a body composition parameter, body fat will be analyzed by body composition automatic analyzer for each participant every 10-20 days.
36 months
Dynamic changes of muscle mass
Time Frame: 36 months
Muscle mass will be analyzed by body composition automatic analyzer for each participant every 10-20 days.
36 months
Dynamic changes of blood lipids
Time Frame: 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.
36 months
Dynamic changes of fasting blood glucose
Time Frame: 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.
36 months
Dynamic changes of homocysteine
Time Frame: 36 months
For participants achieving each 10% weight loss, intravenous serum will be collected and homocysteine will be measured by automatic biochemical analyzer.
36 months
Dynamic changes of blood pressure
Time Frame: 36 months
For participants achieving each 10% weight loss, blood pressure will be measured by the standard electronic sphygmomanometer.
36 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hebei Medical University Third Hospital

Collaborators

Westlake University

Investigators

  • Study Director: Hai-Ling Di, MD, Hebei Medical University Third Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2020

Primary Completion (Actual)

January 1, 2022

Study Completion (Anticipated)

December 1, 2023

Study Registration Dates

First Submitted

December 4, 2019

First Submitted That Met QC Criteria

December 18, 2019

First Posted (Actual)

December 23, 2019

Study Record Updates

Last Update Posted (Actual)

January 20, 2022

Last Update Submitted That Met QC Criteria

January 19, 2022

Last Verified

January 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • YD_20190301

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

The data might be made available 24 months after completion of the study. Requests for access to the study data can be submitted via email to the principal investigator yudan20122013@163.com, and proposals are required to be attached for approval.

IPD Sharing Time Frame

24 months after completion of the study

IPD Sharing Access Criteria

Qualified researchers engaged in rigorous, independent scientific research; Requests for access to the study data should be submitted via email to the principal investigator yudan20122013@163.com, and proposals are required to be attached for approval.

IPD Sharing Supporting Information Type

  • Study Protocol
  • Statistical Analysis Plan (SAP)
  • Informed Consent Form (ICF)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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