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Plant Based Diet, Ethnicity, and the Gut Microbiome

Plant Based Diet, Ethnicity, and the Gut Microbiome

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03314194
Enrollment
38
Registered
2017-10-19
Start date
2017-08-28
Completion date
2019-06-30
Last updated
2021-07-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diet Modification, Microbial Colonization

Brief summary

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

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.

Interventions

Plant Based Diet for 4 Days Compared to Habitual Diet

Sponsors

Seth Bordenstein
CollaboratorUNKNOWN
Vanderbilt University Medical Center
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE

Intervention model description

Pre Post Design

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 40 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Microbial Community Profile4 daysA microbial community profile will be generated for each individual using high-throughput Illumina sequencing of the 16S rDNA microbial gene sequence. This community profile of each subjects microbiome will be assessed from a minimum of 10,000 sequences per individual at multiple timepoints. The profile will be used to quantify how inter-individual variation of the microbiome varies across ethnicities.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 11, 2026