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Effect of Diets on the Gut Microbiota Composition and Cardiometabolic Wellbeing

NCT ID: NCT03539666

Last Updated: 2021-11-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

38 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-07-27

Study Completion Date

2019-04-16

Brief Summary

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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.

Detailed Description

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

Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

SCREENING

Blinding Strategy

NONE

Study Groups

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Pork

Standard American Diet with meat source: lean pork. Diet adheres to 2015-2020 Guidelines for Americans.

Group Type EXPERIMENTAL

diet

Intervention Type OTHER

dietary patterns

Poultry

Standard American Diet with meat source: chicken. Diet adheres to 2015-2020 Guidelines for Americans.

Group Type EXPERIMENTAL

diet

Intervention Type OTHER

dietary patterns

Interventions

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diet

dietary patterns

Intervention Type OTHER

Other Intervention Names

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poultry

Eligibility Criteria

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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.
Minimum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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South Dakota State University

OTHER

Sponsor Role lead

Responsible Party

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Moul Dey

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Moul Dey, Ph.D

Role: PRINCIPAL_INVESTIGATOR

South Dakota State University

Locations

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South Dakota State University, Wagner Hall 416

Brookings, South Dakota, United States

Site Status

Countries

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United States

Other Identifiers

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IRB-1804010-EXP

Identifier Type: -

Identifier Source: org_study_id