NCT07322575

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
• Phase: N/A
• Study type: Interventional
• Enrollment: 65 (estimated)
• Sponsor: National Taiwan University Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Accepted

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.

Conditions

• Gut Dysbiosis for TMAO Production From Red Meat Consumption

Interventions

Type	Name	Description
OTHER	Beef	900 grams of lean beef

Timeline

• Start date: 2026-01-15
• Primary completion: 2026-06-20
• Completion: 2026-11-30
• First posted: 2026-01-07
• Last updated: 2026-01-08

Locations

1 site across 1 country: Taiwan