NCT03378765

Brief 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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
2,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2018

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 14, 2017

Completed
6 days until next milestone

First Posted

Study publicly available on registry

December 20, 2017

Completed
13 days until next milestone

Study Start

First participant enrolled

January 2, 2018

Completed
7.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2025

Completed
Last Updated

March 19, 2024

Status Verified

March 1, 2024

Enrollment Period

7.2 years

First QC Date

December 14, 2017

Last Update Submit

March 18, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • BMI

    Difference in body weight index (BMI) between high and low activity energy expenditure (AEE) groups.

    24 months

Study Arms (1)

African origin adults

African origin adults from Ghana, Jamaica, Seychelles, South Africa and USA between the ages of 30- 50.

Behavioral: Diet and physical activity monitoring

Interventions

Lifestyle monitoring

African origin adults

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

The study is comprises a complex samples population based approach drawn from communities in 5 countries: Ghana, Seychelles, South Africa, Jamaica and the US. Approximately 500 participants are enrolled per site for an unweighted total of 2500 participants.

You may qualify if:

  • Identify as African American or Black
  • Age 18-50

You may not qualify if:

  • Pregnancy, nursing, or planning to become pregnant
  • Movement disorders or other disability that limits mobility

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Loyola University Chicago

Maywood, Illinois, 60153, United States

Location

Related Publications (2)

  • 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.

    PMID: 22168992BACKGROUND
  • Dugas LR, Lie L, Plange-Rhule J, Bedu-Addo K, Bovet P, Lambert EV, Forrester TE, Luke A, Gilbert JA, Layden BT. Gut microbiota, short chain fatty acids, and obesity across the epidemiologic transition: the METS-Microbiome study protocol. BMC Public Health. 2018 Aug 6;18(1):978. doi: 10.1186/s12889-018-5879-6.

Related Links

MeSH Terms

Conditions

ObesityDiabetes Mellitus

Interventions

Diet

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsGlucose Metabolism DisordersMetabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Nutritional Physiological PhenomenaDiet, Food, and NutritionPhysiological Phenomena

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

December 14, 2017

First Posted

December 20, 2017

Study Start

January 2, 2018

Primary Completion

March 1, 2025

Study Completion

March 1, 2025

Last Updated

March 19, 2024

Record last verified: 2024-03

Data Sharing

IPD Sharing
Will not share

Locations