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

Last updated: May 6, 2025
Sponsor: National Taiwan University Hospital
Overall Status: Active - Recruiting

Phase

N/A

Condition

N/A

Treatment

L-carnitine

Clinical Study ID

NCT05980884
202303144RINA
  • Ages 18-70
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

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. Not everyone experiences a significant increase in TMAO levels after consuming carnitine. Gut microbiota differences are observed between high and low TMAO producers. The presence of the gbu gene in gut microbiota is linked to TMAO production. This clinical research aims to determine if the gbu gene can predict TMAO levels after dietary carnitine intake.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Adult with age between 18 to 70

  • Must be able to swallow tablets

Exclusion

Exclusion Criteria:

  • Antibiotics use within one month

  • L-carnitine supplement use within one month

  • Chronic diarrhea

  • Myasthenia gravis

  • Diabetes mellitus

  • Parathyroid disorders

  • Chronic kidney disease

  • Epilepsy

  • Severe anemia

  • Cardiovascular diseases.

Study Design

Total Participants: 230
Treatment Group(s): 1
Primary Treatment: L-carnitine
Phase:
Study Start date:
July 24, 2023
Estimated Completion Date:
July 30, 2026

Study Description

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. Studies have found that red meat, rich in L-carnitine, may be metabolized by certain anaerobic bacteria in the intestines to produce trimethylamine N-oxide (TMAO) in the human body. Previous research utilizing the oral carnitine challenge test (OCCT) revealed that not everyone experiences a significant increase in blood TMAO levels after consuming carnitine. Moreover, individuals with high TMAO production and low TMAO production showed distinct differences in their gut microbiota.

Furthermore, we have discovered a significant correlation between the abundance of the gbu gene in gut microbiota and the production of TMAO in response to dietary carnitine intake. Therefore, through the design of clinical research, we 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.

Connect with a study center

  • National Taiwan University Hospital

    Taipei,
    Taiwan

    Active - Recruiting

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.