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

NCT07322575 | Not Yet Recruiting

• 1 other identifier: 202507141RINB
• Study Type: interventional
• Target: 65
• Locations: 1 country
• Sites: 1

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.

Conditions

Gut Dysbiosis for TMAO Production From Red Meat Consumption

Keywords

TMAO; red meat; carnitine; gut microbiota; gbu gene cluster; cardiovascular disease

Outcome Measures

Primary Outcomes (4)

• Fecal gbu gene abundance measured by qPCR

  up to 7-10 days

• Blood TMAO level measured by LC-MS/MS

  before intervention, 24hr, 48hr after intervention

• Platelet aggregation of blood by Light Transmission Aggregometry

  up to 7-10 days

• Gut microbiome profiles measured by shotgun metagenome sequencing

  up to 7-10 days

Secondary Outcomes (1)

• Carnitine intake measured by 24hr dietary record

  up to 7-10 days

Study Arms (1)

Red meat tolerance test

EXPERIMENTAL

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.

Other: Beef

Interventions

Beef OTHER

900 grams of lean beef

Red meat tolerance test

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult with age between 18 to 70
• Willing and capable of intaking a large amount of beef

You may not qualify if:

• 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.

Sponsors & Collaborators

• National Taiwan University Hospital: lead

Study Sites (1)

National Taiwan University Hospital

Taipei, Taiwan

Location

MeSH Terms

Conditions

Cardiovascular Diseases

Interventions

Red Meat

Intervention Hierarchy (Ancestors)

Meat; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Central Study Contacts

Wei-Kai Wu, MD/PhD

CONTACT

+886958880236; weikaiwu@ntu.edu.tw

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 22, 2025
• First Posted: January 7, 2026
• Study Start: January 15, 2026
• Primary Completion (Estimated): June 20, 2026
• Study Completion (Estimated): November 30, 2026
• Last Updated: January 8, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)