Choline Source, Gut Microbiota and Trimethylamine-N-oxide Response
Effect of Choline Source and Gut Microbiota Composition on Trimethylamine-N-oxide Response in Humans
1 other identifier
interventional
44
1 country
1
Brief Summary
The purpose of this research is to determine the production of trimethylamine-N-oxide (TMAO) from different forms of choline and whether this response is modified by the gut microbiota composition.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Nov 2017
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 9, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 16, 2018
CompletedFirst Submitted
Initial submission to the registry
January 22, 2020
CompletedFirst Posted
Study publicly available on registry
February 5, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
July 25, 2020
CompletedNovember 4, 2020
November 1, 2020
7 months
January 22, 2020
November 3, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
TMAO metabolite concentration change
Plasma TMAO metabolite response
Blood: study baseline, 30 minutes and 1 hour, 2 hours, 4 hours and 6 hours
TMAO metabolite concentration change
Urinary TMAO metabolite response
Urine: study baseline, pooled 6 hours study period
Gut microbiome profile
16S rRNA
Stool: one-time baseline
Secondary Outcomes (5)
One-carbon metabolite concentration change
Blood: study baseline, 30 minutes and 1 hour, 2 hours, 4 hours and 6 hours
Phosphatidylcholine concentration change
Blood: study baseline, 30 minutes and 1 hour, 2 hours, 4 hours and 6 hours
One-carbon metabolite concentration change
Urine: study baseline, pooled 6 hours study period
Inflammation and cardiovascular disease risk marker concentration change
Blood: study baseline to 6 hours
Flavin monooxygenase 3 (FMO3) 472 G>A genotype variant
Blood: study baseline
Study Arms (3)
Water-soluble choline
EXPERIMENTALA breakfast meal consisting of 1 cup of tomato soup containing 600 mg choline as choline bitartrate; served with a bagel with margarine-butter spread and one cup of water.
Fat-soluble choline
EXPERIMENTALA breakfast meal consisting of 1 cup of tomato soup containing 600 mg choline as phosphatidylcholine; served with a bagel with margarine-butter spread and one cup of water.
No choline
ACTIVE COMPARATORA breakfast meal consisting of 1 cup of tomato soup containing no choline; served with a bagel with margarine-butter spread and one cup of water.
Interventions
Eligibility Criteria
You may qualify if:
- Healthy men and women of any race or ethnicity
- Age 21-50 y
- BMI 20-24.9 kg/m2 or BMI 30-39.9 kg/m2
You may not qualify if:
- Age \> 50 y
- BMI outside of the normal-weight or obese range (BMI \< 20 kg/m2; BMI 25-29.9 kg/m2; or BMI \> or = 40 kg/m2)
- Pregnant or planning to become pregnant during the course of the study; currently breastfeeding (females)
- Vegetarians
- Smokers or recreational drug users
- Individuals with gastrointestinal diseases or complaints, chronic illnesses or other metabolic diseases (including trimethylaminuria)
- Individuals who have taken antibiotics within the past 2 months
- Individuals who are not willing to discontinue pre- and probiotics and dietary supplements for the time leading up to 2 months before the study and during the study
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Center for Human Nutrition Studies Clinic, Utah State University
Logan, Utah, 84322, United States
Related Publications (3)
Tang WH, Wang Z, Levison BS, Koeth RA, Britt EB, Fu X, Wu Y, Hazen SL. Intestinal microbial metabolism of phosphatidylcholine and cardiovascular risk. N Engl J Med. 2013 Apr 25;368(17):1575-84. doi: 10.1056/NEJMoa1109400.
PMID: 23614584BACKGROUNDWang Z, Klipfell E, Bennett BJ, Koeth R, Levison BS, Dugar B, Feldstein AE, Britt EB, Fu X, Chung YM, Wu Y, Schauer P, Smith JD, Allayee H, Tang WH, DiDonato JA, Lusis AJ, Hazen SL. Gut flora metabolism of phosphatidylcholine promotes cardiovascular disease. Nature. 2011 Apr 7;472(7341):57-63. doi: 10.1038/nature09922.
PMID: 21475195BACKGROUNDCho CE, Taesuwan S, Malysheva OV, Bender E, Tulchinsky NF, Yan J, Sutter JL, Caudill MA. Trimethylamine-N-oxide (TMAO) response to animal source foods varies among healthy young men and is influenced by their gut microbiota composition: A randomized controlled trial. Mol Nutr Food Res. 2017 Jan;61(1). doi: 10.1002/mnfr.201600324. Epub 2016 Aug 3.
PMID: 27377678BACKGROUND
Study Officials
- PRINCIPAL INVESTIGATOR
Clara E Cho, PhD
Utah State University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- BASIC SCIENCE
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 22, 2020
First Posted
February 5, 2020
Study Start
November 9, 2017
Primary Completion
June 16, 2018
Study Completion
July 25, 2020
Last Updated
November 4, 2020
Record last verified: 2020-11
Data Sharing
- IPD Sharing
- Will not share