Gut Microbiota, Short Chain Fatty Acids, and Adiposity Across The Epidemiological Transition

Obesity Clinical Trial

Official title:

Gut Microbiota, Short Chain Fatty Acids, and Adiposity Across The Epidemiological Transition

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03378765
• Other study ID #: 209537
• Status: Active, not recruiting
• Start date: January 2, 2018
• Est. completion date: March 2025

Study information

• Verified date: March 2024
• Source: Loyola University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The objective of this study is to define associations between gut microbiota, SCFAs and obesity in populations spanning the epidemiologic transition, and explore mechanisms by which these factors may independently and collectively influence the development of obesity. The central hypothesis of this study is that the composition of gut microbiota drives SCFA production which in turn influences obesity risk at the population-level.

Description:

The objective of this study is to define associations between gut microbiota, short chain fatty acids (SCFAs) and obesity in populations spanning the epidemiologic transition, and explore mechanisms by which these factors may independently and collectively influence the development of obesity. The gut microbiota and SCFAs have been associated with obesity, yet the causal mechanisms are unknown, as are the individual obesogenic effects of the individual SCFAs (butyrate, acetate and propionate). Existing studies are, limited by contradictory findings, small sample sizes, limited and imprecise measurements of obesity, and lack of detailed dietary and other environmental exposures/mediators. The investigators propose to overcome these challenges by leveraging an existing cohort of five diverse, well-defined populations from the Modeling the Epidemiologic Transition Study (METS, R01-DK080763). METS is comprised of a cohort of 2,500 African-origin adults, living in 5 distinctly different environments; Ghana, South Africa, Jamaica, the Seychelles and the US, and who have been prospectively followed since 2010. Our preliminary data suggest that while gut microbiota and SCFAs differences exist across sites, similar relationships exist across the sites for gut microbiota/SCFAs adiposity effects. In addition to yearly health measurements; the investigators propose to measure gut microbiota and stool SCFAs in all participants (2500) during the first year of the current study, thus providing one of the largest gut microbiota population-based studies to date. We will divide our cohort of 2500 individuals into 2 sets: (1) a test set of 1000 participants to explore which gut microorganisms and stool SCFAs are associated with adiposity; (2) a validation set of 1500 participants to independently verify the biomarkers identified in the test set, thus minimizing spurious correlations due to large number of features (e.g., bacterial taxa). The investigators will follow all 2500 participants for 3 years to assess weight and adiposity changes, using Bayesian Kernel Machine Regression modeling to explore whether changes can be predicted by gut microbiota and SCFAs factors. Finally, using a causal mediation analysis, the investigators will identify the direct and indirect effect of single and/or cumulative gut microbiota on adiposity as mediated by SCFA. The investigators will thus capitalize upon an existing, extensively well described cohort of adults of African-origin, with significant variability as a result of the widespread geographic distributions, and therefore variation in the environmental covariate exposures. The proposed study will substantially advance the understanding of the role gut microbiota and SCFAs play in the development of obesity and provide novel obesity therapeutic targets targeting SCFAs producing features of the gut microbiota.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 2000
• Est. completion date: March 2025
• Est. primary completion date: March 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

Inclusion Criteria:

• Identify as African American or Black

• Age 18-50

Exclusion Criteria:

• Pregnancy, nursing, or planning to become pregnant

• Movement disorders or other disability that limits mobility

Related Conditions & MeSH terms

• Diabetes
• Obesity

Intervention

Behavioral:
• Diet and physical activity monitoring
Lifestyle monitoring

Locations

Country	Name	City	State
United States	Loyola University Chicago	Maywood	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
Loyola University

Country where clinical trial is conducted

United States, 

References & Publications (1)

Luke A, Bovet P, Forrester TE, Lambert EV, Plange-Rhule J, Schoeller DA, Dugas LR, Durazo-Arvizu RA, Shoham D, Cooper RS, Brage S, Ekelund U, Steyn NP. Protocol for the modeling the epidemiologic transition study: a longitudinal observational study of energy balance and change in body weight, diabetes and cardiovascular disease risk. BMC Public Health. 2011 Dec 14;11:927. doi: 10.1186/1471-2458-11-927. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	BMI	Difference in body weight index (BMI) between high and low activity energy expenditure (AEE) groups.	24 months

External Links

•   METS microbiome project website