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

What Was Tested

This registered not phased trial tested L-Carnitine.

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

It had 1 arm (groups): L-carnitine supplementation (experimental).

The registry classes the interventions as dietary supplement.

More on the Plan

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.

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.

Who Took Part

Enrollment: 56 actual participants took part.

It was open to people of any sex aged from 20 years up to 65 years.

Healthy volunteers could join, not only people with the condition.

Examples of who could join: Healthy subjects aged 20 to 65 years old. No usage of antibiotics within one month. No use of carnitine supplement within one month.

The full record lists 3 inclusion and 7 exclusion criteria; among the exclusions: having serious gi disorder; medical history of myasthenia gravis; history of diabetes,.

How the Study Was Run

The set-up was single-group and open-label.

Nothing was hidden in this open-label L-Carnitine study: the participants and staff both knew the treatment.

Everyone received the same intervention, so there was no separate comparison group inside the trial.

It started in 2016-05-18 with completion listed for 2017-11-20.

It ran at 1 site in Taiwan.

Its stated primary purpose is basic science.

What Was Measured

Researchers chose this as the main measure: TMAO level (time frame: Before and 1 month after L-carnitine supplementation). Compositional and functional alterations of gut microbiota (time frame: Before and 1 month after L-carnitine supplementation).

What This Means in Plain Language

Put simply, this is a not phased trial of L-Carnitine in 56 people.

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the L-Carnitine compound page, all human trials.