DysbiosisNCT06175260
Investigation on the Efficacy of Oral Carnitine Challenge Test Based on a Gut Microbiota Functional Test
An observational study of Dysbiosis and Healthy, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial 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). Read more about this study
- Who is it for?
- Ages 20 years and olderHealthy volunteers can take part
- What is being tested?
- oral carnitine challenge test
- Type of treatment
- Pill or oral medicine
- How many people
- 91 participants
- Where
- 1 siteTaiwan
- Study dates
- 5 Jun 2019to 30 Jun 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Healthy individuals undergoing health examinations at the Health Management Center of National Taiwan University Hospital.
Who may be able to join
- adults aged 20 and above who are willing to participate in the trial.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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).
Read the detailed description
Carnitine, a nutrient widely found in meat, can promote the use of fatty acids by mitochondria to produce energy in the human body. It was previously thought to be beneficial in helping the body consume fat for energy and might be helpful for muscle training or weight loss. However, some human populations have harmful bacteria in their intestines that compete with the body for the use of carnitine. These bacteria metabolize carnitine to produce potentially harmful Trimethylamine N-oxide (TMAO). This might be one of the reasons why long-term consumption of red meat, which is rich in carnitine, is associated with a higher risk of cardiovascular disease. Therefore, understanding the functional state of one's gut microbiota and whether it is suitable to consume foods rich in carnitine can greatly aid in long-term dietary and health planning. In recent years, we have established an oral carnitine challenge test that (OCCT) can distinguish whether the intestinal bacteria in a subject produce a large amount of TMAO in the body. This was published in the Gut journal in 2019 and is expected to provide dietary or nutritional supplement recommendations for personalized nutrition for the test subjects. However, the value of the carnitine challenge test in distinguishing between high TMAO producers and low TMAO producers, and whether it can serve as an effective reference for whether a subject is suitable to consume large amounts of meat or take carnitine supplements, still needs further experimental verification. 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 TMAO, which will be assessed using the OCCT.
- Being tested
- oral carnitine challenge test
- Medical subject headings
- Dysbiosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
Trimethylamine N-oxide (TMAO) production capacity measured by oral carnitine challenge test (OCCT)
The area under the curve of TMAO levels under OCCT
Measured: at enrollment
Secondary outcomes (1)
Correlations between the gut microbiome and the capacity to produce TMAO
The gut microbiome indicated microbial genes and taxonomies measured by shotgun metagenome sequencing whereas TMAO producing capacity was measured by OCCT.
Measured: at enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2023
- Study start5 Jun 2019
- Primary completion14 May 2021
- Study completion30 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DysbiosisStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 91 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ming-Shiang Wu, MD, PhD, Principal investigator, National Taiwan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06175260
- Sponsor's protocol ID
- 201906010RINC
- Status last verified
- Jun 2019
- First submitted
- 7 Dec 2023
- Last updated
- 18 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation on the Efficacy of Oral Carnitine Challenge Test Based on a Gut Microbiota Functional Test
- ClinicalTrials.gov ID
- NCT06175260
- Acronym / sponsor ID
- 201906010RINC
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 91 participants (actual)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- 5 Jun 2019 (actual)
- Primary completion
- 14 May 2021 (actual)
- Study completion
- 30 Jun 2022 (actual)
- First posted
- 18 Dec 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
Carnitine, a nutrient widely found in meat, can promote the use of fatty acids by mitochondria to produce energy in the human body. It was previously thought to be beneficial in helping the body consume fat for energy and might be helpful for muscle training or weight loss. However, some human populations have harmful bacteria in their intestines that compete with the body for the use of carnitine. These bacteria metabolize carnitine to produce potentially harmful Trimethylamine N-oxide (TMAO). This might be one of the reasons why long-term consumption of red meat, which is rich in carnitine, is associated with a higher risk of cardiovascular disease. Therefore, understanding the functional state of one's gut microbiota and whether it is suitable to consume foods rich in carnitine can greatly aid in long-term dietary and health planning. In recent years, we have established an oral carnitine challenge test that (OCCT) can distinguish whether the intestinal bacteria in a subject produce a large amount of TMAO in the body. This was published in the Gut journal in 2019 and is expected to provide dietary or nutritional supplement recommendations for personalized nutrition for the test subjects. However, the value of the carnitine challenge test in distinguishing between high TMAO producers and low TMAO producers, and whether it can serve as an effective reference for whether a subject is suitable to consume large amounts of meat or take carnitine supplements, still needs further experimental verification. 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 TMAO, which will be assessed using the OCCT.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Healthy individuals undergoing health examinations at the Health Management Center of National Taiwan University Hospital.
Key inclusion criteria (1 listed)
- adults aged 20 and above who are willing to participate in the trial.
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| oral carnitine challenge testUrine 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. | Diagnostic test | – |
Primary outcome
Trimethylamine N-oxide (TMAO) production capacity measured by oral carnitine challenge test (OCCT)
Time frame: at enrollment
The area under the curve of TMAO levels under OCCT
1 secondary outcome
Correlations between the gut microbiome and the capacity to produce TMAO
Time frame: at enrollment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Dec 2023.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ming-Shiang Wu, MD, PhD principal investigator
National Taiwan University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Dysbiosis and Healthy, run by National Taiwan University Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Trimethylamine N-oxide (TMAO) production capacity measured by oral carnitine challenge test (OCCT) (time frame: at enrollment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Dec 2023.