NCT06175260

Completed

Investigation on the Efficacy of Oral Carnitine Challenge Te...

National Taiwan University Hospital Source

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Other study identifiers

Sponsor study identifier

201906010RINC

Study Type

observational

Actual enrollment (reported)

91

Locations

1 country

Sites

1

Timeline

Study Start

June 5, 2019

Actual (reported)

Primary Completion

May 14, 2021

Actual (reported)

Study Completion

June 30, 2022

Actual (reported)

Brief Summary

This study seeks to enlist healthy volunteers to form a validation cohort. The purpose is to confirm the observed correlations between the gut microbiome and the capacity to produce trimethylamine N-oxide (TMAO), which will be assessed using the oral carnitine challenge test (OCCT).

Registry Overview

Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.

Recruitment status: completed
Actual enrollment (reported): 91 participants
Study completion date: June 30, 2022
Actual (reported)
Listed locations: 1 countries · 1 sites

Trial Relationships

Click on a node to explore related trials.

Some registry-reported names shown below are not yet linked in this graph.

Study Timeline

Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.

Study Start
June 5, 2019
Actual (reported)
Primary Completion
May 14, 2021
Actual (reported)
Study Completion
June 30, 2022
Actual (reported)
First Submitted
December 7, 2023
Actual (reported)
First Posted
December 18, 2023
Actual (reported)

Last Updated: December 18, 2023
Status Verified: June 2019
Last Update Submitted: December 14, 2023

Conditions

Dysbiosis Healthy

Outcome Measures

Primary Outcomes (1)

Trimethylamine N-oxide (TMAO) production capacity measured by oral carnitine challenge test (OCCT)
The area under the curve of TMAO levels under OCCT
at enrollment

Secondary Outcomes (1)

Correlations between the gut microbiome and the capacity to produce TMAO
at enrollment

Interventions

oral carnitine challenge testDiagnostic test

Urine samples will be collected to quantify trimethylamine N-oxide (TMAO) levels at four time points: before, and 24, 48, and 72 hours after the oral administration of 1500 mg of L-carnitine.

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age20 Years+

Sexall

Healthy VolunteersYes

Age GroupsAdult (18-64), Older Adult (65+)

Sampling MethodProbability Sample

Study Population

Healthy individuals undergoing health examinations at the Health Management Center of National Taiwan University Hospital.

You may qualify if:

adults aged 20 and above who are willing to participate in the trial.

You may not qualify if:

Sponsors & Collaborators

National Taiwan University Hospital
Otherlead

Study Sites (1)

National Taiwan University Hospital

Taipei, Taiwan

Biospecimen

Retention: SAMPLES WITH DNA

DNA from fecal samples were extracted and stored.

MeSH Terms

Conditions

Dysbiosis

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

Ming-Shiang Wu, MD, PhD
National Taiwan University Hospital
PRINCIPAL INVESTIGATOR

Enrollment

91 participants (actual enrollment reported by the registry).

Study Design

Study Type: observational
Observational Model: COHORT
Time Perspective: PROSPECTIVE
Sponsor Type: OTHER
Responsible Party: SPONSOR

Study Record Dates

First Submitted

December 7, 2023

First Posted

December 18, 2023

Study Start

June 5, 2019

Actual (reported)

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Under the age of 20
History of gastrointestinal surgery
History of malignant tumors
Those who have used antibiotics, probiotics, or carnitine supplements within the past month will be excluded
Liver cirrhosis
End-stage kidney disease

Contact the study team to confirm eligibility.

Primary Completion

May 14, 2021

Actual (reported)

Study Completion

June 30, 2022

Actual (reported)

Last Updated

December 18, 2023

Record last verified: 2019-06

Source record

Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.

Source: ClinicalTrials.gov.

JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.

Registry identifier: NCT06175260
Data provider: ClinicalTrials.gov
Source updated: 2023-12-18
Normalization version: ctgov-legacy-1

Open registry record

Source retrieved: 2026-10-25 22:17:34 UTC

Locations

TW(1)

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

Primary Completion

Study Completion

First Submitted

First Posted

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (1)

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (1)

Biospecimen

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

Source record

Locations