Skip to content

Development of Microbial Metabolism Gene Tests for Facilitating Precision Health and Preventive Medicine-Evaluation of TMAO Production in Human Body From High-carnitine Diet by Fecal Gbu Gene Testing

Evaluation of TMAO Production in Human Body From High-carnitine Diet by Fecal Gbu Gene Testing

Status
Not yet recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07322575
Enrollment
65
Registered
2026-01-07
Start date
2026-01-15
Completion date
2026-11-30
Last updated
2026-01-08

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 Red Meat Consumption

Keywords

TMAO, red meat, carnitine, gut microbiota, gbu gene cluster, 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 Trimethylamine n-oxide (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 γ-butyrobetaine utilization (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 intaking a large amount of red meat.

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 a large amount of red meat consumption.

Interventions

OTHERBeef

900 grams of lean beef

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 * Willing and capable of intaking a large amount of beef

Exclusion criteria

* Antibiotics use within one month * L-carnitine supplement use within one month * Chronic diarrhea * Myasthenia gravis * Parathyroid disorders * Chronic kidney disease * Epilepsy * Severe anemia * Severe cardiovascular diseases.

Design outcomes

Primary

MeasureTime frame
Fecal gbu gene abundance measured by qPCRup to 7-10 days
Blood TMAO level measured by LC-MS/MSbefore intervention, 24hr, 48hr after intervention
Platelet aggregation of blood by Light Transmission Aggregometryup to 7-10 days
Gut microbiome profiles measured by shotgun metagenome sequencingup to 7-10 days

Secondary

MeasureTime frame
Carnitine intake measured by 24hr dietary recordup to 7-10 days

Countries

Taiwan

Contacts

Primary ContactWei-Kai Wu, MD/PhD
weikaiwu@ntu.edu.tw+886958880236

Outcome results

None listed

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