Plant Based Diet, Ethnicity, and the Gut Microbiome
Primary Purpose
Diet Modification, Microbial Colonization
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Plant Based Diet
Sponsored by
About this trial
This is an interventional basic science trial for Diet Modification
Eligibility Criteria
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
Sites / Locations
- Vanderbilt University Medical Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Plant Based Diet Group
Arm Description
Study aims for two cohorts of 20 females each, being tested over 6 days in two conditions: habitual diet versus plant based diet.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT03314194
First Posted
August 28, 2017
Last Updated
July 15, 2021
Sponsor
Vanderbilt University Medical Center
Collaborators
Seth Bordenstein
1. Study Identification
Unique Protocol Identification Number
NCT03314194
Brief Title
Plant Based Diet, Ethnicity, and the Gut Microbiome
Official Title
Plant Based Diet, Ethnicity, and the Gut Microbiome
Study Type
Interventional
2. Study Status
Record Verification Date
July 2021
Overall Recruitment Status
Completed
Study Start Date
August 28, 2017 (Actual)
Primary Completion Date
June 30, 2019 (Actual)
Study Completion Date
June 30, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Vanderbilt University Medical Center
Collaborators
Seth Bordenstein
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diet Modification, Microbial Colonization
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Pre Post Design
Masking
None (Open Label)
Allocation
N/A
Enrollment
38 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Plant Based Diet Group
Arm Type
Experimental
Arm Description
Study aims for two cohorts of 20 females each, being tested over 6 days in two conditions: habitual diet versus plant based diet.
Intervention Type
Other
Intervention Name(s)
Plant Based Diet
Intervention Description
Plant Based Diet for 4 Days Compared to Habitual Diet
Primary Outcome Measure Information:
Title
Microbial Community Profile
Description
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.
Time Frame
4 days
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Heidi J Silver, Ph.D.
Organizational Affiliation
Research Associate Professor
Official's Role
Principal Investigator
Facility Information:
Facility Name
Vanderbilt University Medical Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
No Plan
Citations:
PubMed Identifier
35998206
Citation
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.
Results Reference
derived
Learn more about this trial
Plant Based Diet, Ethnicity, and the Gut Microbiome
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