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

National Taiwan University

Status: Active, not recruiting

Conditions: Gut Dysbiosis for TMAO Production From L-carnitine Consumption

Treatments: Dietary Supplement: L-carnitine

Study type: Interventional

Funder types: Other

Identifiers

NCT05980884

202303144RINA

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 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.

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 dietary carnitine intake.

Enrollment: 230 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Basic Science

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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230 participants in 1 patient group

L-Carnitine supplementation

Experimental group

Description:

Participants are required to take a capsule containing 500mg L-carnitine/day continuous for 7-10 days. During the intervention, participants are asked to collect urine sample and dietary record each day. Blood and fecal samples will be collected before and after the intervention. Each participant needs to complete a food frequency questionnaire.

Treatment:

Dietary Supplement: L-carnitine