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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

No phase Interventional Gut Dysbiosis for TMAO Production From Red Meat Consumption

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Beef.
Who it may be relevant to
Registry conditions: Gut Dysbiosis for TMAO Production From Red Meat Consumption. Basic parameters: 18 years — 70 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Taiwan
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

Evaluation of TMAO Production in Human Body From High-carnitine Diet by Fecal Gbu Gene Testing

Overview

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.

Interventions

  • Other Beef
    900 grams of lean beef

Primary outcome measures

  • 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 outcome measures (1)
  • Carnitine intake measured by 24hr dietary record [Time frame: up to 7-10 days]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Basic science

Study locations

Taiwan · 1 center
  • National Taiwan University Hospital — Taipei

Identifiers

NCT: NCT07322575 · 202507141RINB

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗