Effect of Diets on the Gut Microbiota Composition and Cardiometabolic Wellbeing

NCT03539666 | Completed

• 1 other identifier: IRB-1804010-EXP
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy

Outcome Measures

Primary Outcomes (2)

• Microbiota-dependent TMAO-response, measured as serum concentration

  targeted sequencing

  10 days per diet arm

• Serum concentration of biogenic amine metabolites

  Metabolomics

  10 days per diet arm

Study Arms (2)

Pork

EXPERIMENTAL

Standard American Diet with meat source: lean pork. Diet adheres to 2015-2020 Guidelines for Americans.

Other: diet

Poultry

EXPERIMENTAL

Standard American Diet with meat source: chicken. Diet adheres to 2015-2020 Guidelines for Americans.

Other: diet

Interventions

diet OTHER

dietary patterns

Also known as: poultry

Pork; Poultry

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• South Dakota State University: lead

Study Sites (1)

South Dakota State University, Wagner Hall 416

Brookings, South Dakota, 57007, United States

Location

MeSH Terms

Interventions

Diet; Poultry

Intervention Hierarchy (Ancestors)

Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena; Meat; Food; Food and Beverages

Study Officials

• Moul Dey, Ph.D

  South Dakota State University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: May 16, 2018
• First Posted: May 29, 2018
• Study Start: July 27, 2018
• Primary Completion: March 14, 2019
• Study Completion: April 16, 2019
• Last Updated: November 10, 2021

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)