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Effect of Diets on the Gut Microbiota Composition and Cardiometabolic Wellbeing

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ClinicalTrials.gov Identifier: NCT03539666
Recruitment Status : Recruiting
First Posted : May 28, 2018
Last Update Posted : January 4, 2019
Sponsor:
Information provided by (Responsible Party):
Moul Dey, 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.

Condition or disease Intervention/treatment Phase
Healthy Other: diet Not Applicable

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

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 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 : July 27, 2018
Estimated Primary Completion Date : March 14, 2020
Estimated Study Completion Date : December 30, 2020

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 Name: poultry

Experimental: Poultry
Standard American Diet with meat source: chicken. Diet adheres to 2015-2020 Guidelines for Americans.
Other: diet
dietary patterns
Other Name: poultry




Primary Outcome Measures :
  1. Microbiota [ Time Frame: 10 days ]
    targeted sequencing



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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • generally good health status based on one routine physical in the past 15 months, current health status, medication usage, vitamin/mineral supplement use, no probiotic, long-term antibiotic, and tobacco/drug/alcohol use),
  • normal HbA1C
  • Must weigh 110 lb or more
  • Age 50 years or more
  • Males and females
  • generally practicing a meat-based dietary pattern, and
  • willingness to comply with the study protocol

Exclusion Criteria:

  • impaired kidney functions
  • major chronic diseases such as cancer, inflammatory bowel disease
  • history of heart attacks or stroke
  • Unable to meet in-person visit requirements for dining, picking up meals, and tests

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03539666


Contacts
Contact: Moul Dey, Ph.D 605-688-4050 Moul.Dey@sdstate.edu

Locations
United States, South Dakota
South Dakota State University, Wagner Hall 416 Recruiting
Brookings, South Dakota, United States, 57007
Contact: Moul Dey         
Principal Investigator: Moul Dey, PhD         
Sponsors and Collaborators
South Dakota State University
Investigators
Principal Investigator: Moul Dey, Ph.D South Dakota State University

Responsible Party: Moul Dey, Professor, South Dakota State University
ClinicalTrials.gov Identifier: NCT03539666     History of Changes
Other Study ID Numbers: IRB-1804010-EXP
First Posted: May 28, 2018    Key Record Dates
Last Update Posted: January 4, 2019
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No