Gut Flora Metabolite Reduction After Dietary Intervention (GRADY)
The Cleveland Clinic · NCT02016430
Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.
Key facts
- Compensation
- Not posted. Ask the study team before screening.
- Who can join
- Ages 18+ · All sexes
- Healthy volunteers
- Accepted
- Study type
- Interventional · Not applicable
- Target enrollment
- 170
- US sites recruiting
- 1
- Study start
- April 4, 2014
- Record last updated
- June 25, 2026
Status re-checked against ClinicalTrials.gov within the last 12 hours.
What the study is about
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.
Being studied: MeLT Dietary intervention; TLC Dietary intervention; MeLT dietary intervention with TMAO
Conditions: Dietary Modification; Cardiovascular Risk Factor
Eligibility criteria
Copied from the official record. The study team makes the final decision at screening.
Show full 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
Recruiting US locations
Cleveland Clinic
Cleveland, OH 44195
Site contact: Jennifer D Wilcox, BA · 216-636-6153 · kirsopj@ccf.org
Study contacts (from the official record)
- Jennifer Wilcox, BA · 216-636-6153 · kirsopj@ccf.org
- Valesha Province, MA · 216-636-6153 · provinv@ccf.org
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