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

Sponsor
National Taiwan University Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT05980884
Collaborator
(none)
30
1
1
5.3
5.7

Study Details

Study Description

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 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.

Condition or Disease Intervention/Treatment Phase
  • Dietary Supplement: L-carnitine
N/A

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 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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
30 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Basic Science
Official Title:
Evaluation of Microbial-derived TMAO Production From Carnitine Intake by Testing Fecal Bbu Gene
Actual Study Start Date :
Jul 24, 2023
Anticipated Primary Completion Date :
Dec 31, 2023
Anticipated Study Completion Date :
Dec 31, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: L-Carnitine supplementation

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

Outcome Measures

Primary Outcome Measures

  1. Blood TMAO level measured by LC-MS/MS [up to 7-10 days]

  2. Urine TMAO level measured by LC-MS/MS [up to 7-10 days]

  3. Fecal bbuB gene abundance measured by qPCR [up to 7-10 days]

Secondary Outcome Measures

  1. Carnitine intake measured by 24hr dietary record [up to 7-10 days]

  2. Gut microbiome profiles measured by shotgun metagenome sequencing [up to 7-10 days]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 70 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 National Taiwan University Hospital Taipei Taiwan

Sponsors and Collaborators

  • National Taiwan University Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
National Taiwan University Hospital
ClinicalTrials.gov Identifier:
NCT05980884
Other Study ID Numbers:
  • 202303144RINA
First Posted:
Aug 8, 2023
Last Update Posted:
Aug 8, 2023
Last Verified:
Jul 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 8, 2023