Mediterranean DietTMEDNCT03060811
Mediterranean Diet, Trimethylamine N-oxide (TMAO) and Anti-oxidants in Healthy Adults
An observational study of Mediterranean Diet and Trimethylamine N-oxide, run by Federico II University.
Trial summary
Trimethylamine N-oxide (TMAO) is a small organic compound naturally present in fish and seefood or generated by the bacterial breakdown of dietary phosphatidylcholine and carnitine-containing foods within the human gut microbiome. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Mediterranean Diet, Trimethylamine N-oxide, Cardiovascular Risk Factor
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- 22 Sep 2016to 1 Feb 2017
- 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 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Healthy subjects (n=84) aged 21-50 years with a BMI of 20-29.9 kg/m2, chosen among hospital volunteers and employees from the same geographical area. A sample size of n=40 was determined from a power analysis of a within-subject design to detect a 10% difference of plasma TMAO concentration at alfa<0.05 and β =0.8. Participants were screened by the use of a blood chemistry profile, cell count, and health history questionnaire.
Who may be able to join
- healthy subjects of both gender
Who cannot join
- age>65 years
- > BMI 30 kg/m2
- vegetarians
- smokers
- gastrointestinal diseases or complaints
- chronic illnesses or other metabolic diseases (including trimethylaminuria)
- abnormal blood chemistry values indicative of organ dysfunctions
- nutritional supplements, antibiotics or probiotics within 2 months of recruitment
About this study
Trimethylamine N-oxide (TMAO) is a small organic compound naturally present in fish and seefood or generated by the bacterial breakdown of dietary phosphatidylcholine and carnitine-containing foods within the human gut microbiome. Elevated serum TMAO was previously reported to be associated with an elevated risk for cardiovascular events.
Aim of this study was to investigate the association between plasma levels of TMAO with the Mediterranean diet in a cohort of healthy adults.
What is being measured
The primary outcome is the main question the study is designed to answer.
Adherence to Mediterranean Diet by Predimed Questionnaire
Validated 14-item tool of adherence to the Mediterranean diet, with three categories of adherence (≤5, low adherence, 6-9, average adherence and ≥10 points, high adherence)
Measured: September 2016 to December 2016
Trimethylamine N-oxide plasma levels
ultra high-performance liquid chromatography
Measured: September 2016 to December 2016
Secondary outcomes (1)
cardiovascular risk
metabolic syndrome parameters; Homa Index; Framingham score; ASCVD Risk Estimator
Measured: September 2016 to December 2016
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2017
- Study start22 Sep 2016
- Primary completion22 Dec 2016
- Study completion1 Feb 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mediterranean DietStudies of the same condition, open and under way.
- More trials run by Federico II UniversityThe 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
- Cross-sectional
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Federico II University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prof. Silvia Savastano, Federico II University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03060811
- Sponsor's protocol ID
- 173/16
- Acronym
- TMED
- Status last verified
- Feb 2017
- First submitted
- 14 Feb 2017
- Last updated
- 27 Feb 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mediterranean Diet, Trimethylamine N-oxide (TMAO) and Anti-oxidants in Healthy Adults
- ClinicalTrials.gov ID
- NCT03060811
- Acronym / sponsor ID
- TMED / 173/16
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Federico II UniversityUniversity, hospital or other
- Study start
- 22 Sep 2016 (actual)
- Primary completion
- 22 Dec 2016 (actual)
- Study completion
- 1 Feb 2017 (actual)
- First posted
- 23 Feb 2017 (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.
Trimethylamine N-oxide (TMAO) is a small organic compound naturally present in fish and seefood or generated by the bacterial breakdown of dietary phosphatidylcholine and carnitine-containing foods within the human gut microbiome. Elevated serum TMAO was previously reported to be associated with an elevated risk for cardiovascular events.
Aim of this study was to investigate the association between plasma levels of TMAO with the Mediterranean diet in a cohort of healthy adults.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Healthy subjects (n=84) aged 21-50 years with a BMI of 20-29.9 kg/m2, chosen among hospital volunteers and employees from the same geographical area. A sample size of n=40 was determined from a power analysis of a within-subject design to detect a 10% difference of plasma TMAO concentration at alfa<0.05 and β =0.8. Participants were screened by the use of a blood chemistry profile, cell count, and health history questionnaire.
Key inclusion criteria (1 listed)
- healthy subjects of both gender
Key exclusion criteria (8 listed)
- age>65 years
- > BMI 30 kg/m2
- vegetarians
- smokers
- gastrointestinal diseases or complaints
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Adherence to Mediterranean Diet by Predimed Questionnaire
Time frame: September 2016 to December 2016
Validated 14-item tool of adherence to the Mediterranean diet, with three categories of adherence (≤5, low adherence, 6-9, average adherence and ≥10 points, high adherence)
Trimethylamine N-oxide plasma levels
Time frame: September 2016 to December 2016
ultra high-performance liquid chromatography
1 secondary outcome
cardiovascular risk
Time frame: September 2016 to December 2016
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 27 Feb 2017.
- Individual participant dataSharing planned: No
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Effect of Mediterranean Diet in Inflammatory Bowel Disease
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Mediterranean Diet and Trimethylamine N-oxide, run by Federico II University.
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 8 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 27 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
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?
Adherence to Mediterranean Diet by Predimed Questionnaire (time frame: September 2016 to December 2016). 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?
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 27 Feb 2017.