Gut Dysbiosis for TMAO Production From Red Meat ConsumptionNCT07322575
Development of Microbial Metabolism Gene Tests for Facilitating Precision Health and Preventive Medicine-Evaluation of TMAO Production in Human Body From High-carnitine Diet by Fecal Gbu Gene Testing
A study testing Beef in people with Gut Dysbiosis for TMAO Production From Red Meat Consumption, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial 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 Trimethylamine n-oxide (TMAO) in the body by certain bacteria. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Gut Dysbiosis for TMAO Production From Red Meat Consumption
- What is being tested?
- Beef
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 65 participants
- Where
- 1 siteTaiwan
- Study dates
- 15 Jan 2026to 30 Nov 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adult with age between 18 to 70
- Willing and capable of intaking a large amount of beef
Who cannot join
- Antibiotics use within one month
- L-carnitine supplement use within one month
- Chronic diarrhea
- Myasthenia gravis
- Parathyroid disorders
- Chronic kidney disease
Show all 9Show fewer
- Epilepsy
- Severe anemia
- Severe cardiovascular diseases.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Taiwan1 site
National Taiwan University Hospital
Taipei
Wei-Kai Wu, MD/PhD, +886-2-3366-9314, weikaiwu@ntu.edu.tw
About this study
Official title: Evaluation of TMAO Production in Human Body From High-carnitine Diet by Fecal Gbu Gene Testing
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 Trimethylamine n-oxide (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 γ-butyrobetaine utilization (gbu) gene in gut microbiota is linked to TMAO production. This clinical research aims to determine if the gbu gene can predict TMAO levels after intaking a large amount of red meat.
Read the 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 abundance of the gbu 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 gbu gene in gut microbiota can predict the levels of TMAO produced in the human body under a large amount of red meat consumption.
- Being tested
- Beef
- Keywords
- TMAO, red meat, carnitine, gut microbiota, gbu gene cluster, 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.
BeefOther
900 grams of lean beef
| Study group | Role | What they receive |
|---|---|---|
| Red meat tolerance test | Experimental | Participants are required to take 900 grams of beef in a meal. Before the intervention, participants are asked to dietary record two day before the intervention. Fecal samples will be collected before and after the intervention. Blood sample will be collected in 0hr, 24hr, 48hr after the intervention. Each participant needs to complete a food frequency questionnaire. Receives: Other: Beef |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fecal gbu gene abundance measured by qPCR
Measured: up to 7-10 days
Blood TMAO level measured by LC-MS/MS
Measured: before intervention, 24hr, 48hr after intervention
Platelet aggregation of blood by Light Transmission Aggregometry
Measured: up to 7-10 days
Gut microbiome profiles measured by shotgun metagenome sequencing
Measured: up to 7-10 days
Secondary outcomes (1)
Carnitine intake measured by 24hr dietary record
Measured: up to 7-10 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2026
- Study start15 Jan 2026 (estimated)
- Primary completion20 Jun 2026 (estimated)
- Study completion30 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gut Dysbiosis for TMAO Production From Red Meat ConsumptionStudies 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
- Masking
- None (open label)
- Enrolment
- 65 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07322575
- Sponsor's protocol ID
- 202507141RINB
- Status last verified
- Dec 2025
- First submitted
- 22 Dec 2025
- Last updated
- 8 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The data will be uploaded to be public when the research is published
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of TMAO Production in Human Body From High-carnitine Diet by Fecal Gbu Gene Testing
- ClinicalTrials.gov ID
- NCT07322575
- Acronym / sponsor ID
- 202507141RINB
- Keywords
- TMAO, red meat, carnitine, gut microbiota, gbu gene cluster, cardiovascular disease
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 65 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- 15 Jan 2026 (estimated)
- Primary completion
- 20 Jun 2026 (estimated)
- Study completion
- 30 Nov 2026 (estimated)
- First posted
- 7 Jan 2026 (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 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 Trimethylamine n-oxide (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 γ-butyrobetaine utilization (gbu) gene in gut microbiota is linked to TMAO production. This clinical research aims to determine if the gbu gene can predict TMAO levels after intaking a large amount of red meat.
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 abundance of the gbu 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 gbu gene in gut microbiota can predict the levels of TMAO produced in the human body under a large amount of red meat consumption.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Red meat tolerance test | Experimental | Other: BeefParticipants are required to take 900 grams of beef in a meal. Before the intervention, participants are asked to dietary record two day before the intervention. Fecal samples will be collected before and after the intervention. Blood sample will be collected in 0hr, 24hr, 48hr after the intervention. Each participant needs to complete a food frequency questionnaire. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Adult with age between 18 to 70
- Willing and capable of intaking a large amount of beef
Key exclusion criteria (9 listed)
- Antibiotics use within one month
- L-carnitine supplement use within one month
- Chronic diarrhea
- Myasthenia gravis
- Parathyroid disorders
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 |
|---|---|---|
| Beef900 grams of lean beef | Other | Red meat tolerance test |
Primary outcome
Fecal gbu gene abundance measured by qPCR
Time frame: up to 7-10 days
Blood TMAO level measured by LC-MS/MS
Time frame: before intervention, 24hr, 48hr after intervention
Platelet aggregation of blood by Light Transmission Aggregometry
Time frame: up to 7-10 days
Gut microbiome profiles measured by shotgun metagenome sequencing
Time frame: up to 7-10 days
1 secondary outcome
Carnitine intake measured by 24hr dietary record
Time frame: up to 7-10 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jan 2026.
- Individual participant dataSharing planned: No. The data will be uploaded to be public when the research is published
Related trials for Gut Dysbiosis for TMAO Production From Red Meat Consumption
Active, not recruiting
Using Gut Microbial Gbu Gene Testing to Estimate Host TMAO Production Capacity
Gut Dysbiosis for TMAO Production From L-carnitine Consumption
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Beef in people with Gut Dysbiosis for TMAO Production From Red Meat Consumption, 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 2 inclusion and 9 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: opening soon, as of the sponsor's last update on 8 Jan 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Wei-Kai Wu, MD/PhD (+886958880236, weikaiwu@ntu.edu.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fecal gbu gene abundance measured by qPCR (time frame: up to 7-10 days). The study lists 4 primary outcomes in all. 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 8 Jan 2026.