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Modified Atkins Diet for Overweight and Obesity

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04207879
Enrollment
75
Registered
2019-12-23
Start date
2020-01-01
Completion date
2023-12-31
Last updated
2022-01-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Overweight or Obesity

Keywords

modified Atkins Diet, Overweight, Obesity, Gut Microbiome, Body composition

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.

Interventions

None listed

Sponsors

Westlake University
CollaboratorOTHER
Hebei Medical University Third Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Dynamic changes of gut microbiome36 monthsThe 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 metabolomics36 monthsFor 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

MeasureTime frameDescription
Dynamic changes of muscle mass36 monthsMuscle mass will be analyzed by body composition automatic analyzer for each participant every 10-20 days.
Dynamic changes of blood lipids36 monthsFor 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 body mass index36 monthsWeight and height will be combined to report BMI in kg/m\^2.
Dynamic changes of homocysteine36 monthsFor participants achieving each 10% weight loss, intravenous serum will be collected and homocysteine will be measured by automatic biochemical analyzer.
Dynamic changes of blood pressure36 monthsFor participants achieving each 10% weight loss, blood pressure will be measured by the standard electronic sphygmomanometer.
Dynamic changes of fasting blood glucose36 monthsFor participants achieving each 10% weight loss, intravenous serum will be collected and fasting blood glucose will be measured by automatic biochemical analyzer.
Dynamic changes of body fat36 monthsAs a body composition parameter, body fat will be analyzed by body composition automatic analyzer for each participant every 10-20 days.

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 18, 2026