Plant Based Diet, Ethnicity, and the Gut Microbiome

Microbial Colonization Clinical Trial

Official title:

Plant Based Diet, Ethnicity, and the Gut Microbiome

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03314194
• Other study ID #: 171170
• Status: Completed
• Phase: N/A
• Start date: August 28, 2017
• Est. completion date: June 30, 2019

Study information

• Verified date: July 2021
• Source: Vanderbilt University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 38
• Est. completion date: June 30, 2019
• Est. primary completion date: June 30, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

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

Related Conditions & MeSH terms

• Communicable Diseases
• Diet Modification
• Infection
• Microbial Colonization

Intervention

Other:
• Plant Based Diet
Plant Based Diet for 4 Days Compared to Habitual Diet

Locations

Country	Name	City	State
United States	Vanderbilt University Medical Center	Nashville	Tennessee

Sponsors (2)

Lead Sponsor	Collaborator
Vanderbilt University Medical Center	Seth Bordenstein

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Microbial Community Profile	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.	4 days