Evaluation of TMAO Production in Human Body From High-carnitine Diet by Fecal Gbu Gene Testing
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Enrollment
- 65
- Locations
- 1
- Primary Endpoint
- Fecal gbu gene abundance measured by qPCR
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Basic Science
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 70 Years (Adult, Older Adult)
- Sex
- All
- Accepts 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
- •Severe anemia
- •Severe cardiovascular diseases.
Outcomes
Primary Outcomes
Fecal gbu gene abundance measured by qPCR
Time Frame: up to 7-10 days
Blood TMAO level measured by LC-MS/MS
Time Frame: before intervention, 24hr, 48hr after intervention
Platelet aggregation of blood by Light Transmission Aggregometry
Time Frame: up to 7-10 days
Gut microbiome profiles measured by shotgun metagenome sequencing
Time Frame: up to 7-10 days
Secondary Outcomes
- Carnitine intake measured by 24hr dietary record(up to 7-10 days)