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Gut Flora Metabolite Reduction After Dietary Intervention (GRADY)

NCT02016430 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 170

Last updated 2025-10-29

No results posted yet for this study

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

Interventions

BEHAVIORAL

MeLT Dietary intervention

Mediterranean diet containing food with low TMAO content.

BEHAVIORAL

TLC Dietary intervention

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

BEHAVIORAL

MeLT dietary intervention with TMAO

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

Sponsors & Collaborators

  • The Cleveland Clinic

    lead OTHER

Principal Investigators

  • W. H. Wilson Tang, MD · The Cleveland Clinic

  • Stanley L. Hazen, MD · The Cleveland Clinic

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2014-04-04
Primary Completion
2026-12-31
Completion
2026-12-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02016430 on ClinicalTrials.gov