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Effect of Diets on the Gut Microbiota Composition and Cardiometabolic Wellbeing

Sponsor
South Dakota State University (Other)
Overall Status
Completed
CT.gov ID
NCT03539666
Collaborator
(none)
38
Enrollment
1
Location
2
Arms
8.6
Actual Duration (Months)
4.4
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: diet
 N/A

Detailed Description

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

Study Design

Study Type:
Interventional
Actual Enrollment :
38 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
None (Open Label)
Primary Purpose:
Screening
Official Title:
The Effect of Pork and Chicken Diets on Gut Microbiota Composition and Metabolites Related to Cardiometabolic Wellbeing
Actual Study Start Date :
Jul 27, 2018
Actual Primary Completion Date :
Mar 14, 2019
Actual Study Completion Date :
Apr 16, 2019

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Microbiota-dependent TMAO-response, measured as serum concentration [10 days per diet arm]

      targeted sequencing

    2. Serum concentration of biogenic amine metabolites [10 days per diet arm]

      Metabolomics

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    50 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 South Dakota State University, Wagner Hall 416 Brookings South Dakota United States 57007

    Sponsors and Collaborators

    • South Dakota State University

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Moul Dey, Professor, South Dakota State University
    ClinicalTrials.gov Identifier:
    NCT03539666
    Other Study ID Numbers:
    • IRB-1804010-EXP
    First Posted:
    May 29, 2018
    Last Update Posted:
    Nov 10, 2021
    Last Verified:
    Oct 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No

    Study Results

    No Results Posted as of Nov 10, 2021