Evaluation of Microbial-derived TMAO Production From Carnitine Intake by Testing Fecal Bbu Gene

Study Overview
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Brief Summary
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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 bbu gene in gut microbiota is linked to TMAO production. This clinical research aims to determine if the bbu gene can predict TMAO levels after carnitine intake.

Detailed Description
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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 presence of the bbu 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 bbu gene in gut microbiota can predict the levels of TMAO produced in the human body after consuming carnitine.

Official Title
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Evaluation of Microbial-derived TMAO Production From Carnitine Intake by Testing Fecal Bbu Gene

Conditions
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Gut Dysbiosis for TMAO Production From L-carnitine Consumption

Intervention / Treatment
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* Dietary Supplement: L-carnitine


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: L-Carnitine supplementation<br>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. | Dietary Supplement: L-carnitine<br>* Participants are required to take a capsule containing 500mg L-carnitine/day continuous for 7-10 days.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood TMAO level measured by LC-MS/MS |  | up to 7-10 days | 
| Urine TMAO level measured by LC-MS/MS |  | up to 7-10 days | 
| Fecal bbuB gene abundance measured by qPCR |  | up to 7-10 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Carnitine intake measured by 24hr dietary record |  | up to 7-10 days | 
| Gut microbiome profiles measured by shotgun metagenome sequencing |  | up to 7-10 days |