NCT02016430 Gut Flora Metabolite Reduction After Dietary Intervention (GRADY)
| NCT ID | NCT02016430 |
| Status | Recruiting |
| Phase | — |
| Sponsor | The Cleveland Clinic |
| Condition | Dietary Modification |
| Study Type | INTERVENTIONAL |
| Enrollment | 170 participants |
| Start Date | 2014-04-04 |
| Primary Completion | 2026-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 170 participants in total. It began in 2014-04-04 with a primary completion date of 2026-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Our group has recently identified the association between gut-flora-mediated carnitine and phosphatidylcholine metabolism, specifically trimethylamine-N-oxide (TMAO), and cardiovascular risk. This study investigates the ability for dietary intervention to modulate TMAO levels.
Eligibility Criteria
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
Contact & Investigator
W. H. Wilson Tang, MD
PRINCIPAL INVESTIGATOR
The Cleveland Clinic
Frequently Asked Questions
Who can join the NCT02016430 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Dietary Modification. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT02016430 currently recruiting?
Yes, NCT02016430 is actively recruiting participants. Contact the research team at kirsopj@ccf.org for enrollment information.
Where is the NCT02016430 trial being conducted?
This trial is being conducted at Cleveland, United States.
Who is sponsoring the NCT02016430 clinical trial?
NCT02016430 is sponsored by The Cleveland Clinic. The principal investigator is W. H. Wilson Tang, MD at The Cleveland Clinic. The trial plans to enroll 170 participants.