Effect of Diets on the Gut Microbiota Composition and Cardiometabolic Wellbeing

Not Applicable

Completed

• Conditions: Healthy
• Interventions: Other: diet

• Registration Number: NCT03539666
• Lead Sponsor: South Dakota State University

Brief Summary

The project will characterize human gut microbiome response to two different diets and the possible physiological and biochemical implications of such response on cardiometabolic risk factors. The study will use controlled-feeding, systems-biology, metagenomic, and metabolomic approaches to examine American dietary patterns.

Detailed Description

The study will use controlled-feeding, systems-biology, metagenomic, and metabolomic approaches to examine American dietary patterns.

Study Timeline

• Study First Submitted: 2018-05-16
• Study First Submitted QC: 2018-05-16
• Study First Posted: 2018-05-29
• Study Start: 2018-07-27
• Primary Completion: 2019-03-14
• Study Completion: 2019-04-16
• Status Verified: 2021-10
• Last Update Submitted: 2021-10-22
• Last Update Posted: 2021-11-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 38

Inclusion Criteria

• generally good health status based on one routine physical in the past 15 months, current health status
• normal HbA1C, weigh 110 lb or more
• Age 50 years or more, generally healthy, all races and both sexes
• generally practicing a meat-based dietary pattern, do not have any special dietary requirement, and
• willingness to comply with the study protocol, including on-site meal consumption and sample/data collection.

Exclusion Criteria

• medication usage, probiotic, long-term antibiotic, and tobacco/drug/alcohol use
• Not on any special diet within 3 months of recruitment, and do not have any intention to lose weight.
• impaired kidney functions
• Active history of cancer, diabetes, heart, liver, and kidney diseases
• major gastrointestinal disorders in the past 3 months
• history of heart attacks or stroke
• Unable to meet in-person visit requirements for dining, picking up meals, and tests
• Any mental health condition that would affect the ability to provide written informed consent.
• If they had not had a routine health checkup during the 12 months prior to recruitment.
• If they were unwilling to abstain from taking nutritional supplements, alcohol, non-study foods, and beverage during the study period.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Poultry	diet	Standard American Diet with meat source: chicken. Diet adheres to 2015-2020 Guidelines for Americans.
Pork	diet	Standard American Diet with meat source: lean pork. Diet adheres to 2015-2020 Guidelines for Americans.

Primary Outcome Measures

Name	Time	Method
Microbiota-dependent TMAO-response, measured as serum concentration	10 days per diet arm	targeted sequencing
Serum concentration of biogenic amine metabolites	10 days per diet arm	Metabolomics

Trial Locations

Locations (1)

South Dakota State University, Wagner Hall 416; 🇺🇸 Brookings, South Dakota, United States