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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

65 participants

Study Classification

INTERVENTIONAL

Study Start Date

2026-01-15

Study Completion Date

2026-11-30

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 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.

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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 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

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Gut Dysbiosis for TMAO Production From Red Meat Consumption

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Red meat tolerance test

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.

Group Type EXPERIMENTAL

Beef

Intervention Type OTHER

900 grams of lean beef

Interventions

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Beef

900 grams of lean beef

Intervention Type OTHER

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes