Clinical trial NCT04207879: Modified Atkins Diet for Overweight and Obesity
Official title: Longitudinal Profiling of Gut Microbiome in Overweight or Obese Participants on a Modified Atkins Diet: a Prospective Cohort Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Overweight or Obesity
Keywords: modified Atkins Diet
Overweight
Obesity
Gut Microbiome
Body composition
Lead sponsor: Hebei Medical University Third Hospital
Sponsor class: OTHER
Collaborators: name: Westlake University
First posted: 2019-12-23
Enrollment: 75
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Dynamic changes of gut microbiome
timeFrame: 36 months
measure: Dynamic changes in faecal metabolomics
timeFrame: 36 months
Secondary outcomes:
measure: Dynamic changes of body mass index
timeFrame: 36 months
measure: Dynamic changes of body fat
timeFrame: 36 months
measure: Dynamic changes of muscle mass
timeFrame: 36 months
measure: Dynamic changes of blood lipids
timeFrame: 36 months
measure: Dynamic changes of fasting blood glucose
timeFrame: 36 months
measure: Dynamic changes of homocysteine
timeFrame: 36 months
measure: Dynamic changes of blood pressure
timeFrame: 36 months
Other outcomes:
Locations:
city: Shijiazhuang
country: China
facility: Hebei Medical University Third Hospital
state: Hebei
Study officials:
affiliation: Hebei Medical University Third Hospital
name: Hai-Ling Di, MD
role: STUDY_DIRECTOR
References:
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.
citation: Frost F, Storck LJ, Kacprowski T, Gartner S, Ruhlemann M, Bang C, Franke A, Volker 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.
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.
citation: Yu D, Chen W, Zhang J, Wei L, Qin J, Lei M, Tang H, Wang Y, Xue S, Dong J, Chen Y, Xie L, Di H. Effects of weight loss on bone turnover, inflammatory cytokines, and adipokines in Chinese overweight and obese adults. J Endocrinol Invest. 2022 Sep;45(9):1757-1767. doi: 10.1007/s40618-022-01815-5. Epub 2022 May 30.