Recruiting

Dietary Intervention

Sponsor:

The Cleveland Clinic

Code:

NCT02016430

Conditions

Dietary Modification

Cardiovascular Risk Factor

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

MeLT Dietary intervention

TLC Dietary intervention

MeLT dietary intervention with TMAO

Study Details

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.

Conditions

Dietary Modification

Cardiovascular Risk Factor

Study ID

NCT02016430

Start date

Apr 4, 2014

Status verified date

Jun, 2026

Completion date

Dec, 2026

Anticipated

Primary completion date

Dec, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

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

Study Design

Enrollment

170 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: MeLT Dietary intervention

Mediterranean Low-TMAO (MeLT) diet. Used in cohorts 1, 2 and 3.

experimental: TLC Dietary intervention

Therapeutic Lifestyle Changes (TLC) diet. Used in cohorts 1, 2 and 3.

experimental: MeLT dietary intervention with TMAO

Mediterranean Low TMAO diet with TMAO levels reported. Used in cohort 1 only.

Interventions

MeLT Dietary intervention

Mediterranean diet containing food with low TMAO content.

TLC Dietary intervention

Standard American Heart Association (AHA) recommendations for dietary counseling.

MeLT dietary intervention with TMAO

Mediterranean diet containing food with low TMAO content with TMAO levels provided to the subject for guidance.

Primary outcome measure

  • Change in TMAO level [ Time Frame: From baseline to 12 weeks follow-up ]

Central Contacts and Locations

Central contacts

Jennifer Wilcox, BA

216-636-6153kirsopj@ccf.org

Valesha Province, MA

216-636-6153provinv@ccf.org

Locations

Cleveland Clinic

Recruiting

Cleveland, Ohio, United States, 44195

Contacts

Jennifer D Wilcox, BA

216-636-6153kirsopj@ccf.org

Principal Investigator:

W. H. Wilson Tang, MD

More Information

Sponsor

The Cleveland Clinic

Last update posted

Jun 25, 2026

Last verified

Jun, 2026

Keywords

  • TMAO
  • Gut Flora
  • Dietary Intervention
  • Choline
  • Carnitine

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by The Cleveland Clinic on 2026-06-25.