Dietary ModificationNCT03781011
Oral Carnitine Challenge Test Guides Personalized Nutrition for CV Patients
A study testing Vegetarian diet intervention in people with Dietary Modification and Cardiovascular Diseases, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
The investigators plan to use the recently developed oral carnitine challenge test (OCCT) as a tool to exam individual's trimethylamine N-oxide (TMAO) production capacity from their gut microbiota. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Dietary Modification, Cardiovascular Diseases
- What is being tested?
- Vegetarian diet intervention
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteTaiwan
- Study dates
- 19 Oct 2018to 19 Oct 2020
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient with risks of cardiovascular disease (CAD) or CAD patients proved by coronary angiography
Who cannot join
- age < 20, hx of GI surgery, hx of malignancy, antibiotic or probiotic or carnitine supplement use within one month, liver cirrhosis, end stage chronic renal disease
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Investigation on Clinical Application of Oral Carnitine Challenge Test as a Guidance of Personalized Nutrition for Patients With Cardiovascular Disease
The investigators plan to use the recently developed oral carnitine challenge test (OCCT) as a tool to exam individual's trimethylamine N-oxide (TMAO) production capacity from their gut microbiota. By using data collected by OCCT, the investigators defined subjects as high-TMAO producer or low-TMAO producer and apply low carnitine/choline diet as dietary intervention for the high-TMAO producers. After dietary intervention for two months, the investigators conducted OCCT for the participants and compare the TMAO production capacity before and after the dietary intervention.
Read the detailed description
Patients diagnosed with cardiovascular disease at the CV clinics are being recruited to undergo the Oral Carnitine Challenge Test (OCCT) to assess the TMAO production capacity of their gut microbiota. Participants identified as high-TMAO producers will be invited to partake in a two-month vegetarian diet intervention, supervised by a registered dietitian, followed by a three-month period of reverting to their regular diet. The OCCT will be conducted before and after the vegetarian diet intervention, as well as after the diet recovery phase. Fecal samples will be collected and analyzed at the baseline, in the second month, and in the fifth month of the study.
- Conditions
- Dietary Modification, Cardiovascular Diseases
- Being tested
- Vegetarian diet intervention
- Keywords
- Gut microbiota, Trimethylamine N-oxide, Oral carnitine challenge test, Cardiovascular disease
- Medical subject headings
- Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vegetarian diet interventionBehavioural
Patients will received dietary education and supervision by dietician to avoid high carnitine/choline foods including red meat, eggs...etc.
| Study group | Role | What they receive |
|---|---|---|
| Vegetarian diet intervention | Experimental | Patients identified as high-TMAO producers through the oral carnitine challenge test will be invited to participate in a two-month vegetarian diet intervention, supervised by a registered dietitian. Receives: Behavioral: Vegetarian diet intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
TMAO production capacity
TMAO production capacity is measured by calculating the area under the curve of TMAO levels (quantification by LC-MS/MS) during the procedure of oral carnitine challenge test
Measured: Baseline, at the second month (following a two-month vegetarian diet intervention), and at the fifth month (after resuming a regular diet for three months).
Secondary outcomes (1)
Compositional and functional changes 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: Baseline, at the second month (following a two-month vegetarian diet intervention), and at the fifth month (after resuming a regular diet for three months).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2018
- Study start19 Oct 2018
- Primary completion19 Oct 2019
- Study completion19 Oct 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dietary ModificationStudies 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
- Participants identified as high-TMAO producers through the oral carnitine challenge test will be invited to participate in a two-month vegetarian diet intervention.
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ming-shiang Wu, Study director, National Taiwan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03781011
- Sponsor's protocol ID
- 201712030RIND
- Status last verified
- Oct 2020
- First submitted
- 10 Dec 2018
- Last updated
- 18 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
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 Clinical Application of Oral Carnitine Challenge Test as a Guidance of Personalized Nutrition for Patients With Cardiovascular Disease
- ClinicalTrials.gov ID
- NCT03781011
- Acronym / sponsor ID
- 201712030RIND
- Conditions
- Dietary Modification, Cardiovascular Diseases
- Keywords
- Gut microbiota, Trimethylamine N-oxide, Oral carnitine challenge test, Cardiovascular disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- 19 Oct 2018 (actual)
- Primary completion
- 19 Oct 2019 (actual)
- Study completion
- 19 Oct 2020 (actual)
- First posted
- 19 Dec 2018 (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.
The investigators plan to use the recently developed oral carnitine challenge test (OCCT) as a tool to exam individual's trimethylamine N-oxide (TMAO) production capacity from their gut microbiota. By using data collected by OCCT, the investigators defined subjects as high-TMAO producer or low-TMAO producer and apply low carnitine/choline diet as dietary intervention for the high-TMAO producers. After dietary intervention for two months, the investigators conducted OCCT for the participants and compare the TMAO production capacity before and after the dietary intervention.
Detailed description
Patients diagnosed with cardiovascular disease at the CV clinics are being recruited to undergo the Oral Carnitine Challenge Test (OCCT) to assess the TMAO production capacity of their gut microbiota. Participants identified as high-TMAO producers will be invited to partake in a two-month vegetarian diet intervention, supervised by a registered dietitian, followed by a three-month period of reverting to their regular diet. The OCCT will be conducted before and after the vegetarian diet intervention, as well as after the diet recovery phase. Fecal samples will be collected and analyzed at the baseline, in the second month, and in the fifth month of the study.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Participants identified as high-TMAO producers through the oral carnitine challenge test will be invited to participate in a two-month vegetarian diet intervention.
| Arm | Type | Receives |
|---|---|---|
| Vegetarian diet intervention | Experimental | Behavioral: Vegetarian diet interventionPatients identified as high-TMAO producers through the oral carnitine challenge test will be invited to participate in a two-month vegetarian diet intervention, supervised by a registered dietitian. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patient with risks of cardiovascular disease (CAD) or CAD patients proved by coronary angiography
Key exclusion criteria (1 listed)
- age < 20, hx of GI surgery, hx of malignancy, antibiotic or probiotic or carnitine supplement use within one month, liver cirrhosis, end stage chronic renal 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 |
|---|---|---|
| Vegetarian diet interventionPatients will received dietary education and supervision by dietician to avoid high carnitine/choline foods including red meat, eggs...etc. | Behavioural | Vegetarian diet intervention |
Primary outcome
TMAO production capacity
Time frame: Baseline, at the second month (following a two-month vegetarian diet intervention), and at the fifth month (after resuming a regular diet for three months).
TMAO production capacity is measured by calculating the area under the curve of TMAO levels (quantification by LC-MS/MS) during the procedure of oral carnitine challenge test
1 secondary outcome
Compositional and functional changes of gut microbiota
Time frame: Baseline, at the second month (following a two-month vegetarian diet intervention), and at the fifth month (after resuming a regular diet for three months).
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.
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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 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 Vegetarian diet intervention in people with Dietary Modification and Cardiovascular Diseases, 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 1 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 production capacity (time frame: Baseline, at the second month (following a two-month vegetarian diet intervention), and at the fifth month (after resuming a regular diet for three months).). 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.