Modified Atkins Diet for Overweight and Obesity

Overweight or Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04207879
• Other study ID #: YD_20190301
• Status: Active, not recruiting
• Start date: January 1, 2020
• Est. completion date: December 2023

Study information

• Verified date: January 2022
• Source: Hebei Medical University Third Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 75
• Est. completion date: December 2023
• Est. primary completion date: January 1, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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.

Related Conditions & MeSH terms

• Obesity
• Overweight
• Overweight or Obesity

Locations

Country	Name	City	State
China	Hebei Medical University Third Hospital	Shijiazhuang	Hebei

Sponsors (2)

Lead Sponsor	Collaborator
Hebei Medical University Third Hospital	Westlake University

Country where clinical trial is conducted

China, 

References & Publications (3)

Frost F, Storck LJ, Kacprowski T, Gärtner S, Rühlemann M, Bang C, Franke A, Völker U, Aghdassi AA, Steveling A, Mayerle J, Weiss FU, Homuth G, Lerch MM. A structured weight loss program increases gut microbiota phylogenetic diversity and reduces levels of Collinsella in obese type 2 diabetics: A pilot study. PLoS One. 2019 Jul 18;14(7):e0219489. doi: 10.1371/journal.pone.0219489. eCollection 2019. — View Citation

Heianza Y, Sun D, Smith SR, Bray GA, Sacks FM, Qi L. Changes in Gut Microbiota-Related Metabolites and Long-term Successful Weight Loss in Response to Weight-Loss Diets: The POUNDS Lost Trial. Diabetes Care. 2018 Mar;41(3):413-419. doi: 10.2337/dc17-2108. Epub 2018 Jan 5. — View Citation

Lin BY, Lin WD, Huang CK, Hsin MC, Lin WY, Pryor AD. Changes of gut microbiota between different weight reduction programs. Surg Obes Relat Dis. 2019 May;15(5):749-758. doi: 10.1016/j.soard.2019.01.026. Epub 2019 Jan 31. — View Citation

Outcome

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