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Choline Source, Gut Microbiota and Trimethylamine-N-oxide Response

NCT ID: NCT04255368

Last Updated: 2020-11-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

44 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-11-09

Study Completion Date

2020-07-25

Brief Summary

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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.

Detailed Description

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The overall goal of this research is to identify dietary and physiological factors contributing to elevated levels of trimethylamine-N-oxide (TMAO), a choline-derived gut-microbiome-dependent metabolite that has been identified to increase cardiovascular disease risk. Our recent findings indicate that the gut microbiome may account for variations in TMAO levels, whereby those with a greater enrichment of Firmicutes to Bacteroidetes had elevated TMAO response to dietary precursor intake. However, the interaction between choline intake and gut microbiota composition as a determinant of interindividual variations in TMAO response has not been investigated. This study sought to i) compare plasma and urinary TMAO response after acute challenge containing different forms of choline; and ii) to determine the association between differences in TMAO response with differences in gut microbiota composition. To accomplish these objectives, a randomized, controlled cross-over study was conducted in healthy participants (n=41). The study incorporated three arms comprised of study meals containing (i) 600 mg choline as choline bitartrate; (ii) 600 mg choline as phosphatidylcholine; or (iii) no choline. Each meal was served with a bagel with margarine-butter spread and one cup of water, administered in a single day and separated by a 1-week washout period. Baseline blood sample was obtained by a phlebotomist using a standard venipuncture procedure, and participants collected their baseline urine sample. They also turned in a one-time self-collected baseline stool sample. Following the consumption of the study meal, serial blood samples were collected at 30 min and 1, 2, 4 and 6 h, and urine samples collected throughout the 6 h study period. At 4.5 h, participants were provided a fixed fruit snack (i.e., 2 single serving prepackaged applesauce) and water.

Conditions

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Metabolism

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Randomized, controlled crossover design where participants consume 3 meals containing (i) free choline; (ii) phosphatidylcholine; or (iii) no choline in a random order separated by a 1-week washout period
Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Water-soluble choline

A 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.

Group Type EXPERIMENTAL

Water-soluble choline

Intervention Type OTHER

600 mg choline as choline bitartrate

Fat-soluble choline

A 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.

Group Type EXPERIMENTAL

Fat-soluble choline

Intervention Type OTHER

600 mg choline as phosphatidylcholine

No choline

A 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.

Group Type ACTIVE_COMPARATOR

No choline control

Intervention Type OTHER

No choline

Interventions

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Water-soluble choline

600 mg choline as choline bitartrate

Intervention Type OTHER

Fat-soluble choline

600 mg choline as phosphatidylcholine

Intervention Type OTHER

No choline control

No choline

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* 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
Minimum Eligible Age

21 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Utah State University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Clara E Cho, PhD

Role: PRINCIPAL_INVESTIGATOR

Utah State University

Locations

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Center for Human Nutrition Studies Clinic, Utah State University

Logan, Utah, United States

Site Status

Countries

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United States

References

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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.

Reference Type BACKGROUND
PMID: 23614584 (View on PubMed)

Wang 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.

Reference Type BACKGROUND
PMID: 21475195 (View on PubMed)

Cho 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.

Reference Type BACKGROUND
PMID: 27377678 (View on PubMed)

Other Identifiers

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8547

Identifier Type: -

Identifier Source: org_study_id