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Investigation on the Effect of Carnitine Supplement on Gut Microbiota and TMAO Production Capacity

NCT ID: NCT02838732

Last Updated: 2023-12-18

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

56 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-05-18

Study Completion Date

2019-10-07

Brief Summary

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In this project, the investigators aim to explore the impact of dietary L-carnitine supplementation on the TMAO production capacity of gut microbiota.

Detailed Description

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Recent studies have established plasma trimethylamine N-oxide (TMAO) levels as a strong, independent risk factor for cardiovascular disease. TMAO is produced by the interaction between gut microflora and ingested L-carnitine from food. Research indicates that both plasma TMAO concentration and the TMAO production capacity of gut microbiota in vegetarians are significantly lower than in omnivores, likely due to the reduced L-carnitine intake in vegetarian diets. This study aims to explore the impact of L-carnitine supplementation on the TMAO production capacity of human gut microbiota and to identify TMAO-producing bacteria within the gut microflora. The study plans to recruit both omnivore and vegetarian volunteers to undergo a one-month L-carnitine supplementation, followed by an evaluation of changes in TMAO production using an oral L-carnitine challenge test, along with gut microbiota assessment. TMAO concentration will be measured using LC-MS/MS, and gut microbiome analysis will be conducted through shotgun metagenome sequencing. Bioinformatic analysis may reveal potential TMAO-producing bacteria. Understanding the changes in TMAO production and gut microbiota composition post-L-carnitine supplementation may enhance our knowledge of the interplay between L-carnitine supplements, TMAO, and gut microflora.

Conditions

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Dietary Exposure

Keywords

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Gut microbiota Trimethylamine N-oxide L-carnitine supplementation Oral carnitine challenge test

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

All participants received L-carnitine supplementation (500 mg per tablet per day, GNC) for one month. Oral carnitine challenge tests and fecal sampling were conducted both before and after the intervention.
Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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L-carnitine supplementation

All participants received L-carnitine supplementation (500 mg per tablet per day, provided by GNC) for one month. Oral carnitine challenge tests and fecal sampling were conducted both before and after the intervention.

Group Type EXPERIMENTAL

L-carnitine supplementation (500 mg per tablet per day, purchased from GNC company)

Intervention Type DIETARY_SUPPLEMENT

Interventions

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L-carnitine supplementation (500 mg per tablet per day, purchased from GNC company)

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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Inclusion Criteria

* Healthy subjects aged 20 to 65 years old
* no usage of antibiotics within one month
* no use of carnitine supplement within one month

Exclusion Criteria

* having serious GI disorder
* medical history of myasthenia gravis
* history of diabetes,
* history of hyperparathyroidism,
* history of chronic kidney disease
* history of epilepsy
* history of severe anemia
Minimum Eligible Age

20 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Taiwan University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Ming-Shiang Wu, MD, PhD

Role: STUDY_DIRECTOR

National Taiwan University Hospital

Locations

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National Taiwan University Hospital

Taipei, , Taiwan

Site Status

Countries

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Taiwan

References

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Wu WK, Chen CC, Liu PY, Panyod S, Liao BY, Chen PC, Kao HL, Kuo HC, Kuo CH, Chiu THT, Chen RA, Chuang HL, Huang YT, Zou HB, Hsu CC, Chang TY, Lin CL, Ho CT, Yu HT, Sheen LY, Wu MS. Identification of TMAO-producer phenotype and host-diet-gut dysbiosis by carnitine challenge test in human and germ-free mice. Gut. 2019 Aug;68(8):1439-1449. doi: 10.1136/gutjnl-2018-317155. Epub 2018 Oct 30.

Reference Type DERIVED
PMID: 30377191 (View on PubMed)

Other Identifiers

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201507055MINC

Identifier Type: -

Identifier Source: org_study_id