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

National Taiwan University

Status: Not yet enrolling

Conditions: Gut Dysbiosis for TMAO Production From Red Meat Consumption

Treatments: Other: Beef

Study type: Interventional

Funder types: Other

Identifiers

NCT07322575

202507141RINB

Details and patient eligibility

About

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.

Full 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.

Enrollment: 65 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Basic Science

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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65 participants in 1 patient group

Red meat tolerance test

Experimental group

Description:

Participants are required to take 900 grams of beef in a meal. Before the intervention, participants are asked to dietary record two day before the intervention. Fecal samples will be collected before and after the intervention. Blood sample will be collected in 0hr, 24hr, 48hr after the intervention. Each participant needs to complete a food frequency questionnaire.

Treatment:

Other: Beef