Diet trial targets gut chemical to cut heart risk
NCT ID NCT02016430
First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 2 times
Summary
This study tests whether a Mediterranean diet with low-TMAO foods can lower levels of TMAO, a gut bacteria byproduct linked to heart disease. Researchers will compare this diet to standard heart-healthy advice in 170 adults with high TMAO. The goal is to see if diet alone can reduce this risk factor.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Mediterranean diet with low TMAO foods
- What this could lead to
- If successful, this could show that a simple diet change reduces a key heart disease risk factor, offering a practical way to lower cardiovascular risk.
- What could go wrong
- This is an early-stage study with only 170 participants, so results may not apply to everyone. Dietary changes can be hard to stick with, and TMAO reduction may not directly prevent heart attacks.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 170 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Apr 2014
- Expected to finish
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Dec 2026
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: Cohort 1 Inclusion criteria: * Men and women age 18 years or above. * Elevated TMAO metabolizers (\>5 µM) based on screening test and/or eGFR \< 60 at most recent measurement. * Willing to remain on aspirin or able to be off aspirin or aspirin products for 1 week prior to starting the study and staying on the same aspirin regimen during the duration of the study. * Willing to sign the consent form and follow the study protocol, which includes a 12-week dietary modification. Cohort 2 Inclusion criteria: * Men and women age 18 years or above. * Willing to remain on aspirin or able to be off aspirin or aspirin products for 1 week prior to starting the study and staying on the same aspirin regimen during the duration of the study. * Willing to sign the consent form and follow the study protocol. * eGFR values ranging from 16-59 Cohort 3 Inclusion criteria: * Men and women age 18 years or above. * Willing to remain on aspirin or able to be off aspirin or aspirin products for 1 week prior to starting the study and staying on the same aspirin regimen during the duration of the study. * Willing to sign the consent form and follow the study protocol. Exclusion Criteria (all cohorts): * Significant chronic illness or end-organ dysfunction, including known history of uncompensated heart failure, renal failure, pulmonary disease, hematologic diseases. * Active infection or received antibiotics within 2 months of study enrollment * Use of over-the-counter probiotic within past month, or ingestion of yogurt within past 7 days * Having undergone bariatric procedures or surgeries such as gastric banding or bypass. * Pregnancy. * Any condition which, in the judgment of the Investigator, would place a patient at undue risk by being enrolled in the trial, or cause inability to comply with the trial
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As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Cleveland Clinic
RECRUITINGCleveland, Ohio, 44195, United States
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