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

Evaluation of Microbial-derived TMAO Production From Carnitine Intake by Testing Fecal Gbu Gene

Status
Active, not recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05980884
Enrollment
230
Registered
2023-08-08
Start date
2023-07-24
Completion date
2026-07-30
Last updated
2026-01-12

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

Conditions

Gut Dysbiosis for TMAO Production From L-carnitine Consumption

Keywords

gbu gene cluster, TMAO, gut microbiota, red meat, cardiovascular disease

Brief 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.

Detailed 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.

Interventions

DIETARY_SUPPLEMENTL-carnitine

Participants are required to take a capsule containing 500mg L-carnitine/day continuous for 7-10 days.

Sponsors

National Taiwan University Hospital
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
Yes

Inclusion criteria

* Adult with age between 18 to 70 * Must be able to swallow tablets

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.

Design outcomes

Primary

MeasureTime frame
Blood TMAO level measured by LC-MS/MSup to 7-10 days
Urine TMAO level measured by LC-MS/MSup to 7-10 days
Fecal gbuB gene abundance measured by qPCRup to 7-10 days

Secondary

MeasureTime frame
Carnitine intake measured by 24hr dietary recordup to 7-10 days
Gut microbiome profiles measured by shotgun metagenome sequencingup to 7-10 days

Countries

Taiwan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026