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OpenTrials
Completed

NCT Number: NCT03314194

Plant Based Diet, Ethnicity, and the Gut Microbiome

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.

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Key information

Conditions

Diet Modification Communicable Diseases Disease Attributes Infections Microbial Colonization Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Plant based diet

Other

Plant Based Diet for 4 Days Compared to Habitual Diet

Primary outcomes

  1. Microbial Community Profile

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Vanderbilt University Medical Center

Other

Collaborators

  • Seth Bordenstein

Registry information

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Oct 19, 2017
Registry last updated
Jul 16, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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