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

Primary Purpose

Gut Dysbiosis for TMAO Production From L-carnitine Consumption

Status
Recruiting
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
L-carnitine
Sponsored by
National Taiwan University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Gut Dysbiosis for TMAO Production From L-carnitine Consumption

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • National Taiwan University HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

L-Carnitine supplementation

Arm Description

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.

Outcomes

Primary Outcome Measures

Blood TMAO level measured by LC-MS/MS
Urine TMAO level measured by LC-MS/MS
Fecal bbuB gene abundance measured by qPCR

Secondary Outcome Measures

Carnitine intake measured by 24hr dietary record
Gut microbiome profiles measured by shotgun metagenome sequencing

Full Information

First Posted
July 20, 2023
Last Updated
July 31, 2023
Sponsor
National Taiwan University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05980884
Brief Title
Evaluation of Microbial-derived TMAO Production From Carnitine Intake by Testing Fecal Bbu Gene
Official Title
Evaluation of Microbial-derived TMAO Production From Carnitine Intake by Testing Fecal Bbu Gene
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 24, 2023 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Taiwan University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gut Dysbiosis for TMAO Production From L-carnitine Consumption

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
L-Carnitine supplementation
Arm Type
Experimental
Arm Description
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.
Intervention Type
Dietary Supplement
Intervention Name(s)
L-carnitine
Intervention Description
Participants are required to take a capsule containing 500mg L-carnitine/day continuous for 7-10 days.
Primary Outcome Measure Information:
Title
Blood TMAO level measured by LC-MS/MS
Time Frame
up to 7-10 days
Title
Urine TMAO level measured by LC-MS/MS
Time Frame
up to 7-10 days
Title
Fecal bbuB gene abundance measured by qPCR
Time Frame
up to 7-10 days
Secondary Outcome Measure Information:
Title
Carnitine intake measured by 24hr dietary record
Time Frame
up to 7-10 days
Title
Gut microbiome profiles measured by shotgun metagenome sequencing
Time Frame
up to 7-10 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Wei-Kai Wu, MD/PhD
Phone
+886958880236
Email
weikaiwu0115@gmail.com
Facility Information:
Facility Name
National Taiwan University Hospital
City
Taipei
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Wei-Kai Wu, MD/PhD
Phone
+886958880236
Email
weikaiwu0115@gmail.com
First Name & Middle Initial & Last Name & Degree
Wei-Kai Wu, MD/PhD

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
The data will be uploaded to be public when the research is published

Learn more about this trial

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

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