Effect of Diets on the Gut Microbiota Composition and Cardiometabolic Wellbeing

October 22, 2021 updated by: Moul Dey, South Dakota State University

The Effect of Pork and Chicken Diets on Gut Microbiota Composition and Metabolites Related to Cardiometabolic Wellbeing

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Interventional

Enrollment (Actual)

38

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • South Dakota
      • Brookings, South Dakota, United States, 57007
        • South Dakota State University, Wagner Hall 416

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Screening
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Pork
Standard American Diet with meat source: lean pork. Diet adheres to 2015-2020 Guidelines for Americans.
Other: diet
dietary patterns
Other Names:
  • poultry
Experimental: Poultry
Standard American Diet with meat source: chicken. Diet adheres to 2015-2020 Guidelines for Americans.
Other: diet
dietary patterns
Other Names:
  • poultry

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Microbiota-dependent TMAO-response, measured as serum concentration
Time Frame: 10 days per diet arm
targeted sequencing
10 days per diet arm
Serum concentration of biogenic amine metabolites
Time Frame: 10 days per diet arm
Metabolomics
10 days per diet arm

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

South Dakota State University

Investigators

  • Principal Investigator: Moul Dey, Ph.D, South Dakota State University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 27, 2018

Primary Completion (Actual)

March 14, 2019

Study Completion (Actual)

April 16, 2019

Study Registration Dates

First Submitted

May 16, 2018

First Submitted That Met QC Criteria

May 16, 2018

First Posted (Actual)

May 29, 2018

Study Record Updates

Last Update Posted (Actual)

November 10, 2021

Last Update Submitted That Met QC Criteria

October 22, 2021

Last Verified

October 1, 2021

More Information

Terms related to this study

Other Study ID Numbers

  • IRB-1804010-EXP

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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