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RecruitingAccepts healthy volunteers

Gut Flora Metabolite Reduction After Dietary Intervention (GRADY)

The Cleveland Clinic · NCT02016430

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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
Gut Flora Metabolite Reduction After Dietary Intervention (GRADY) (NCT02016430) | Bored Studies