Plant Based Diet, Ethnicity, and the Gut Microbiome

NCT03314194 | Completed

• 1 other identifier: 171170
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

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.

Conditions

Diet Modification; Microbial Colonization

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Plant Based Diet Group

EXPERIMENTAL

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

Other: Plant Based Diet

Interventions

Plant Based Diet OTHER

Plant Based Diet for 4 Days Compared to Habitual Diet

Plant Based Diet Group

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Vanderbilt University Medical Center: lead
• Seth Bordenstein: collaborator

Study Sites (1)

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

Location

Related Publications (1)

• 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.

  PMID: 35998206 DERIVED

MeSH Terms

Conditions

Communicable Diseases

Interventions

Diet, Plant-Based

Condition Hierarchy (Ancestors)

Infections; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Diet Therapy; Nutrition Therapy; Therapeutics; Diet; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Study Officials

• Heidi J Silver, Ph.D.

  Research Associate Professor

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Associate Professor of Medicine

Model Details: Pre Post Design

Study Record Dates

• First Submitted: August 28, 2017
• First Posted: October 19, 2017
• Study Start: August 28, 2017
• Primary Completion: June 30, 2019
• Study Completion: June 30, 2019
• Last Updated: July 16, 2021

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)