Gut Flora Metabolite Reduction After Dietary Intervention (GRADY)

Part of paid clinical trials in Cleveland, Ohio.

Sponsor
The Cleveland Clinic
Study ID
NCT02016430
Status
Recruiting
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Conditions

  • Cardiovascular Risk Factor
  • Dietary Modification

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • MeLT Dietary intervention — BEHAVIORAL
    Mediterranean diet containing food with low TMAO content.
  • TLC Dietary intervention — BEHAVIORAL
    Standard American Heart Association (AHA) recommendations for dietary counseling.
  • MeLT dietary intervention with TMAO — BEHAVIORAL
    Mediterranean diet containing food with low TMAO content with TMAO levels provided to the subject for guidance.

Study Details

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.

Key Dates

Start date
Apr 4, 2014
Status verified
Oct 2025
Primary completion
Dec 31, 2026
Completion
Dec 31, 2026

Study Design

Enrollment
170 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

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.

Primary Outcome Measure

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

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Cleveland ClinicClevelandOhio44195
Jennifer Wilcox
[email protected]
216-636-6153
W. H. Wilson Tang, MD (PRINCIPAL_INVESTIGATOR)
Stanley L. Hazen, MD (PRINCIPAL_INVESTIGATOR)

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