Dietary ExposureNCT02838732
Investigation on the Effect of Carnitine Supplement on Gut Microbiota and TMAO Production Capacity
A study testing L-carnitine supplementation (500 mg per tablet per day, purchased from GNC company) in people with Dietary Exposure, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
In this project, the investigators aim to explore the impact of dietary L-carnitine supplementation on the TMAO production capacity of gut microbiota. Read more about this study
- Who is it for?
- Ages 20 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Dietary Exposure
- What is being tested?
- L-carnitine supplementation (500 mg per tablet per day, purchased from GNC company)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 1 siteTaiwan
- Study dates
- 18 May 2016to 7 Oct 2019
- Phase
- Interventional
- 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 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy subjects aged 20 to 65 years old
- no usage of antibiotics within one month
- no use of carnitine supplement within one month
Who cannot join
- having serious GI disorder
- medical history of myasthenia gravis
- history of diabetes,
- history of hyperparathyroidism,
- history of chronic kidney disease
- history of epilepsy
- history of severe anemia
Trial locations and contacts
1 site in 1 country.
About this study
In this project, the investigators aim to explore the impact of dietary L-carnitine supplementation on the TMAO production capacity of gut microbiota.
Read the detailed description
Recent studies have established plasma trimethylamine N-oxide (TMAO) levels as a strong, independent risk factor for cardiovascular disease. TMAO is produced by the interaction between gut microflora and ingested L-carnitine from food. Research indicates that both plasma TMAO concentration and the TMAO production capacity of gut microbiota in vegetarians are significantly lower than in omnivores, likely due to the reduced L-carnitine intake in vegetarian diets. This study aims to explore the impact of L-carnitine supplementation on the TMAO production capacity of human gut microbiota and to identify TMAO-producing bacteria within the gut microflora. The study plans to recruit both omnivore and vegetarian volunteers to undergo a one-month L-carnitine supplementation, followed by an evaluation of changes in TMAO production using an oral L-carnitine challenge test, along with gut microbiota assessment. TMAO concentration will be measured using LC-MS/MS, and gut microbiome analysis will be conducted through shotgun metagenome sequencing. Bioinformatic analysis may reveal potential TMAO-producing bacteria. Understanding the changes in TMAO production and gut microbiota composition post-L-carnitine supplementation may enhance our knowledge of the interplay between L-carnitine supplements, TMAO, and gut microflora.
- Conditions
- Dietary Exposure
- Being tested
- L-carnitine supplementation (500 mg per tablet per day, purchased from GNC company)
- Keywords
- Gut microbiota, Trimethylamine N-oxide, L-carnitine supplementation, Oral carnitine challenge test
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
L-carnitine supplementation (500 mg per tablet per day, purchased from GNC company)Dietary supplement
| Study group | Role | What they receive |
|---|---|---|
| L-carnitine supplementation | Experimental | All participants received L-carnitine supplementation (500 mg per tablet per day, provided by GNC) for one month. Oral carnitine challenge tests and fecal sampling were conducted both before and after the intervention. Receives: Dietary Supplement: L-carnitine supplementation (500 mg per tablet per day, purchased from GNC company) |
What is being measured
The primary outcome is the main question the study is designed to answer.
TMAO level
plasma and urine TMAO concentrations of oral carnitine challenge test
Measured: Before and 1 month after L-carnitine supplementation
Compositional and functional alterations of gut microbiota
The compositional and functional changes of gut microbiota will be evaluated by shotgun metagenome sequencing. Taxonomy will be calculated as relative abundance of species-level genome bins (SGBs) and specific bacteria genes will be quantified as Reads Per Kilobase per Million (RPKM).
Measured: Before and 1 month after L-carnitine supplementation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2016 (estimated)
- Study start18 May 2016
- Primary completion20 Nov 2017
- Study completion7 Oct 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Dietary ExposureStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- All participants received L-carnitine supplementation (500 mg per tablet per day, GNC) for one month. Oral carnitine challenge tests and fecal sampling were conducted both before and after the intervention.
- Masking
- None (open label)
- Enrolment
- 56 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, Study director, National Taiwan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02838732
- Sponsor's protocol ID
- 201507055MINC
- Status last verified
- Dec 2023
- First submitted
- 8 Jul 2016
- Last updated
- 18 Dec 2023
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Wu WK, Chen CC, Liu PY, Panyod S, Liao BY, Chen PC, Kao HL, Kuo HC, Kuo CH, Chiu THT, Chen RA, Chuang HL, Huang YT, Zou HB, Hsu CC, Chang TY, Lin CL, Ho CT, Yu HT, Sheen LY, Wu MS. Identification of TMAO-producer phenotype and host-diet-gut dysbiosis by carnitine challenge test in human and germ-free mice. Gut. 2019 Aug;68(8):1439-1449. doi: 10.1136/gutjnl-2018-317155. Epub 2018 Oct 30.
PubMed 30377191
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 Effect of Carnitine Supplement on Gut Microbiota and TMAO Production Capacity
- ClinicalTrials.gov ID
- NCT02838732
- Acronym / sponsor ID
- 201507055MINC
- Conditions
- Dietary Exposure
- Keywords
- Gut microbiota, Trimethylamine N-oxide, L-carnitine supplementation, Oral carnitine challenge test
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- 18 May 2016
- Primary completion
- 20 Nov 2017 (actual)
- Study completion
- 7 Oct 2019 (actual)
- First posted
- 20 Jul 2016 (estimated)
- 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.
In this project, the investigators aim to explore the impact of dietary L-carnitine supplementation on the TMAO production capacity of gut microbiota.
Detailed description
Recent studies have established plasma trimethylamine N-oxide (TMAO) levels as a strong, independent risk factor for cardiovascular disease. TMAO is produced by the interaction between gut microflora and ingested L-carnitine from food. Research indicates that both plasma TMAO concentration and the TMAO production capacity of gut microbiota in vegetarians are significantly lower than in omnivores, likely due to the reduced L-carnitine intake in vegetarian diets. This study aims to explore the impact of L-carnitine supplementation on the TMAO production capacity of human gut microbiota and to identify TMAO-producing bacteria within the gut microflora. The study plans to recruit both omnivore and vegetarian volunteers to undergo a one-month L-carnitine supplementation, followed by an evaluation of changes in TMAO production using an oral L-carnitine challenge test, along with gut microbiota assessment. TMAO concentration will be measured using LC-MS/MS, and gut microbiome analysis will be conducted through shotgun metagenome sequencing. Bioinformatic analysis may reveal potential TMAO-producing bacteria. Understanding the changes in TMAO production and gut microbiota composition post-L-carnitine supplementation may enhance our knowledge of the interplay between L-carnitine supplements, TMAO, and gut microflora.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- All participants received L-carnitine supplementation (500 mg per tablet per day, GNC) for one month. Oral carnitine challenge tests and fecal sampling were conducted both before and after the intervention.
| Arm | Type | Receives |
|---|---|---|
| L-carnitine supplementation | Experimental | Dietary Supplement: L-carnitine supplementation (500 mg per tablet per day, purchased from GNC company)All participants received L-carnitine supplementation (500 mg per tablet per day, provided by GNC) for one month. Oral carnitine challenge tests and fecal sampling were conducted both before and after the intervention. |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Healthy subjects aged 20 to 65 years old
- no usage of antibiotics within one month
- no use of carnitine supplement within one month
Key exclusion criteria (7 listed)
- having serious GI disorder
- medical history of myasthenia gravis
- history of diabetes,
- history of hyperparathyroidism,
- history of chronic kidney disease
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 |
|---|---|---|
| L-carnitine supplementation (500 mg per tablet per day, purchased from GNC company) | Dietary supplement | L-carnitine supplementation |
Primary outcome
TMAO level
Time frame: Before and 1 month after L-carnitine supplementation
plasma and urine TMAO concentrations of oral carnitine challenge test
Compositional and functional alterations of gut microbiota
Time frame: Before and 1 month after L-carnitine supplementation
The compositional and functional changes of gut microbiota will be evaluated by shotgun metagenome sequencing. Taxonomy will be calculated as relative abundance of species-level genome bins (SGBs) and specific bacteria genes will be quantified as Reads Per Kilobase per Million (RPKM).
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.
- Derived from this study: PubMed 30377191Wu WK, Chen CC, Liu PY, Panyod S, Liao BY, Chen PC, Kao HL, Kuo HC, Kuo CH, Chiu THT, Chen RA, Chuang HL, Huang YT, Zou HB, Hsu CC, Chang TY, Lin CL, Ho CT, Yu HT, Sheen LY, Wu MS. Identification of TMAO-producer phenotype and host-diet-gut dysbiosis by carnitine challenge test in human and germ-free mice. Gut. 2019 Aug;68(8):1439-1449. doi: 10.1136/gutjnl-2018-317155. Epub 2018 Oct 30.
- Individual participant dataSharing planned: No
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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 study director
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?
A study testing L-carnitine supplementation (500 mg per tablet per day, purchased from GNC company) in people with Dietary Exposure, 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 3 inclusion and 7 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?
TMAO level (time frame: Before and 1 month after L-carnitine supplementation). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02838732, which also lists 1 linked publication.
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.