Effect of Diets on the Gut Microbiota Composition and Cardiometabolic Wellbeing

Healthy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03539666
• Other study ID #: IRB-1804010-EXP
• Status: Completed
• Phase: N/A
• Start date: July 27, 2018
• Est. completion date: April 16, 2019

Study information

• Verified date: October 2021
• Source: South Dakota State University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 38
• Est. completion date: April 16, 2019
• Est. primary completion date: March 14, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 50 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Healthy

Intervention

Other:
• diet
dietary patterns

Locations

Country	Name	City	State
United States	South Dakota State University, Wagner Hall 416	Brookings	South Dakota

Sponsors (1)

Lead Sponsor	Collaborator
South Dakota State University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Microbiota-dependent TMAO-response, measured as serum concentration	targeted sequencing	10 days per diet arm
Primary	Serum concentration of biogenic amine metabolites	Metabolomics	10 days per diet arm