Plant Based Diet, Ethnicity, and the Gut Microbiome

Not Applicable

Completed

• Conditions: Microbial Colonization; Diet Modification
• Interventions: Other: Plant Based Diet

• Registration Number: NCT03314194
• Lead Sponsor: Vanderbilt University Medical Center

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.

Basic Information
|
Recruitment & Eligibility
|
Study & Design
|
Trial Locations

Study Timeline

• Study Start: 2017-08-28
• Study First Submitted: 2017-08-28
• Study First Submitted QC: 2017-10-13
• Study First Posted: 2017-10-19
• Primary Completion: 2019-06-30
• Study Completion: 2019-06-30
• Status Verified: 2021-07
• Last Update Submitted: 2021-07-15
• Last Update Posted: 2021-07-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 38

Inclusion Criteria

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

Read More

Exclusion Criteria

• Not weight stable
• Using Medications
• Using Dietary Supplements
• Chronic Disease
• Tobacco Use
• Drug Use
• Pregnant or Lactating
• Diet Restrictions
• Vegetarian or Vegan

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Microbial Community Profile	4 days	A 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.

Trial Locations

Locations (1)

Vanderbilt University Medical Center; 🇺🇸 Nashville, Tennessee, United States