Skip to content

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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02838732
Enrollment
56
Registered
2016-07-20
Start date
2016-05-18
Completion date
2019-10-07
Last updated
2023-12-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dietary Exposure

Keywords

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

Brief summary

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

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.

Interventions

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

Sponsors

National Taiwan University Hospital
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE

Intervention model description

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.

Eligibility

Sex/Gender
ALL
Age
20 Years to 65 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
TMAO levelBefore and 1 month after L-carnitine supplementationplasma and urine TMAO concentrations of oral carnitine challenge test
Compositional and functional alterations of gut microbiotaBefore and 1 month after L-carnitine supplementationThe compositional and functional changes of gut microbiota will be evaluated by shotgun metagenome sequencing. Taxonomy will be calculated as relative abundance of species-level genome bins (SGBs) and specific bacteria genes will be quantified as Reads Per Kilobase per Million (RPKM).

Countries

Taiwan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 23, 2026