Using Gut Microbial Gbu Gene Testing to Estimate Host TMAO Production Capacity

What Was Tested

The trial (not phased) is built around L-Carnitine.

The risk of cardiovascular diseases from red meat consumption varies among individuals due to variations in gut microbiota.

L-carnitine in red meat can be converted to TMAO in the body by certain bacteria.

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

The registry classes the interventions as dietary supplement.

More on the Plan

The risk of developing cardiovascular diseases due to the consumption of red meat varies among individuals, and this may be attributed to differences in the composition and function of gut microbiota.

Therefore, through the design of clinical research, the researchers aim to investigate and assess whether the abundance of the gbu gene in gut microbiota can predict the levels of TMAO produced in the human body under dietary carnitine intake.

Who Took Part

The registry lists 230 planned participants were the target.

It was open to people of any sex aged from 18 years up to 70 years.

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

Examples of who could join: Adult with age between 18 to 70. Must be able to swallow tablets.

The full record lists 2 inclusion and 10 exclusion criteria; among the exclusions: antibiotics use within one month; L-carnitine supplement use within one month; chronic diarrhea.

How the Study Was Run

Design: single-group and open-label.

Everyone knew when L-Carnitine was being given (open label), which is simpler to run but leaves more room for expectations to affect what is reported.

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

It started in 2023-07-24 with completion listed for 2026-04-25.

It ran at 1 site in Taiwan.

Its stated primary purpose is basic science.

What Was Measured

Researchers chose this as the main measure: Blood TMAO level measured by LC-MS/MS (time frame: up to 7-10 days). Urine TMAO level measured by LC-MS/MS (time frame: up to 7-10 days). Fecal gbuB gene abundance measured by qPCR (time frame: up to 7-10 days).

It also tracked 2 secondary outcomes, for example Carnitine intake measured by 24hr dietary record and Gut microbiome profiles measured by shotgun metagenome sequencing.

What This Means in Plain Language

Put simply, this is a not phased trial of L-Carnitine in 230 people.

Its status is active not recruiting; no results are posted to the registry yet, so nothing here describes outcomes.

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