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OpenTrials
Completed

NCT Number: NCT03539666

Effect of Diets on the Gut Microbiota Composition and 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.

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Key information

Conditions

Age range

50 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

South Dakota State University, Wagner Hall 416

Brookings, South Dakota, 57007, United States

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Diet

Other

dietary patterns

Other names: poultry

Primary outcomes

  1. Microbiota-dependent TMAO-response, measured as serum concentration

    Time frame: 10 days per diet arm

    targeted sequencing

  2. Serum concentration of biogenic amine metabolites

    Time frame: 10 days per diet arm

    Metabolomics

Sponsors and collaborators

Lead sponsor

South Dakota State University

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
May 29, 2018
Registry last updated
Nov 10, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.