Plant Based Diet, Ethnicity, and the Gut Microbiome

NCT ID: NCT03314194

Last Updated: 2021-07-16

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

2017-08-28

Study Completion Date

2019-06-30

Brief Summary

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Samples will be collected to determine human genetic variation, fecal and oral microbial communities, and metabolome products. Several evolutionary and ecological diversity metrics will be distilled to test: a) if microbiome variation within each ethnicity is less than that between ethnicities; b) if microbiome variation is finely structured according to genetic relatedness; and c) if dietary variation impacts human genome x microbiome associations.

Detailed Description

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To characterize the human gut microbiome under highly controlled dietary intake in healthy normal weight adult participants who differ by ethnicity: White non-Hispanic and Black non-Hispanic adults. Samples will be collected to determine human genetic variation, fecal and oral microbial communities, and metabolome products. Several evolutionary and ecological diversity metrics will be distilled to test: a) if microbiome variation within each ethnicity is less than that between ethnicities; b) if microbiome variation is finely structured according to genetic relatedness; and c) if dietary variation impacts human genome x microbiome associations.

Conditions

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Diet Modification Microbial Colonization

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Pre Post Design
Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Plant Based Diet Group

Study aims for two cohorts of 20 females each, being tested over 6 days in two conditions: habitual diet versus plant based diet.

Group Type EXPERIMENTAL

Plant Based Diet

Intervention Type OTHER

Plant Based Diet for 4 Days Compared to Habitual Diet

Interventions

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Plant Based Diet

Plant Based Diet for 4 Days Compared to Habitual Diet

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Female
* Age 18-40
* BMI 18.5-24.9
* Caucasian or African American

Exclusion Criteria

* Not weight stable
* Using Medications
* Using Dietary Supplements
* Chronic Disease
* Tobacco Use
* Drug Use
* Pregnant or Lactating
* Diet Restrictions
* Vegetarian or Vegan
Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Seth Bordenstein

UNKNOWN

Sponsor Role collaborator

Vanderbilt University Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Heidi J. Silver

Research Associate Professor of Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Heidi J Silver, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Research Associate Professor

Locations

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Vanderbilt University Medical Center

Nashville, Tennessee, United States

Site Status

Countries

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United States

References

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Li J, George Markowitz RH, Brooks AW, Mallott EK, Leigh BA, Olszewski T, Zare H, Bagheri M, Smith HM, Friese KA, Habibi I, Lawrence WM, Rost CL, Ledeczi A, Eeds AM, Ferguson JF, Silver HJ, Bordenstein SR. Individuality and ethnicity eclipse a short-term dietary intervention in shaping microbiomes and viromes. PLoS Biol. 2022 Aug 23;20(8):e3001758. doi: 10.1371/journal.pbio.3001758. eCollection 2022 Aug.

Reference Type DERIVED
PMID: 35998206 (View on PubMed)

Other Identifiers

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171170

Identifier Type: -

Identifier Source: org_study_id

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