NCT05980884

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 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 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 dietary carnitine intake.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
230

participants targeted

Target at P75+ for not_applicable

Timeline
3mo left

Started Jul 2023

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress92%
Jul 2023Jul 2026

First Submitted

Initial submission to the registry

July 20, 2023

Completed
4 days until next milestone

Study Start

First participant enrolled

July 24, 2023

Completed
15 days until next milestone

First Posted

Study publicly available on registry

August 8, 2023

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 25, 2026

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 30, 2026

Expected
Last Updated

January 12, 2026

Status Verified

January 1, 2026

Enrollment Period

2.8 years

First QC Date

July 20, 2023

Last Update Submit

January 8, 2026

Conditions

Gut Dysbiosis for TMAO Production From L-carnitine Consumption

Keywords

gbu gene clusterTMAOgut microbiotared meatcardiovascular disease

Outcome Measures

Primary Outcomes (3)

  • 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 gbuB gene abundance measured by qPCR

    up to 7-10 days

Secondary Outcomes (2)

  • 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

Study Arms (1)

L-Carnitine supplementation

EXPERIMENTAL

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

Interventions

L-carnitineDIETARY_SUPPLEMENT

Participants are required to take a capsule containing 500mg L-carnitine/day continuous for 7-10 days.

L-Carnitine supplementation

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adult with age between 18 to 70
  • Must be able to swallow tablets

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Taiwan University Hospital

Taipei, Taiwan

Location

Related Publications (1)

  • Wu WK, Lo YL, Chiu JY, Hsu CL, Lo IH, Panyod S, Liao YC, Chiu THT, Yang YT, Kuo HC, Zou HB, Chen YH, Chuang HL, Yen JJY, Wang JT, Chiu HM, Hsu CC, Kuo CH, Sheen LY, Kao HL, Wu MS. Gut microbes with the gbu genes determine TMAO production from L-carnitine intake and serve as a biomarker for precision nutrition. Gut Microbes. 2025 Dec;17(1):2446374. doi: 10.1080/19490976.2024.2446374. Epub 2024 Dec 26.

    PMID: 39722590RESULT

MeSH Terms

Conditions

Cardiovascular Diseases

Interventions

Carnitine

Intervention Hierarchy (Ancestors)

Trimethyl Ammonium CompoundsQuaternary Ammonium CompoundsAminesOrganic Chemicals

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

July 20, 2023

First Posted

August 8, 2023

Study Start

July 24, 2023

Primary Completion

April 25, 2026

Study Completion (Estimated)

July 30, 2026

Last Updated

January 12, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

The data will be uploaded to be public when the research is published

Locations

TW(1)