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NCT02016430 · ClinicalTrials.gov registry record · NA

Gut Flora Metabolite Reduction After Dietary Intervention (GRADY)

A NA study of Cardiovascular Risk Factor and Dietary Modification, sponsored by The Cleveland Clinic.

Recruiting
Registry status
NA
Development phase
170
Enrollment target
1
Study location

NCT02016430: Recruiting NA study of Cardiovascular Risk Factor and Dietary Modification, sponsored by The Cleveland Clinic.

NCT02016430 is a NA study of Cardiovascular Risk Factor and Dietary Modification that is actively recruiting participants, run by The Cleveland Clinic. The registered enrollment target is 170 participants, below the 3,063-participant average among 31 other Cardiovascular Risk Factor trials with a reported enrollment target (94% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT02016430, a NA study of Cardiovascular Risk Factor and Dietary Modification, is actively recruiting participants, sponsored by The Cleveland Clinic.

RECRUITING
Registry status
NA
Development phase
170 participants
Enrollment target
1
Study location

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.

Primary Outcome

The change in TMAO concentration measured in blood samples

Interventions

  • BEHAVIORAL MeLT Dietary intervention
  • BEHAVIORAL TLC Dietary intervention
  • BEHAVIORAL MeLT dietary intervention with TMAO

Study Locations (1)

Ohio

  • Cleveland Clinic - Cleveland

Trial Details

FieldValue
Enrollment Target 170 participants
Start Date 2014-04-04
Est. Completion 2026-12
Phase NA
The Cleveland Clinic

688 total trials

What NCT02016430 shows while recruiting

NCT02016430 is an interventional study that assigns participants to a tested intervention. The registered 170 participants enrollment target is mid-sized for trials with a published cap, below the 3,063-participant average among 31 other Cardiovascular Risk Factor trials with a reported enrollment target (94% lower).

The record links to 2 conditions, with Cardiovascular Risk Factor appearing as the primary indexed condition, and to 3 interventions - of which MeLT Dietary intervention is the first listed.

NCT02016430 reports a single indexed study location in Ohio.

Frequently Asked Questions

What is clinical trial NCT02016430 about?

NCT02016430 is a clinical study titled "Gut Flora Metabolite Reduction After Dietary Intervention (GRADY)". 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.

What is the current status of trial NCT02016430?

This trial is currently recruiting. It is a NA study. The enrollment target is 170 participants. The study started on 2014-04-04. Estimated completion is 2026-12.

What conditions does trial NCT02016430 study?

This clinical trial studies the following conditions: Cardiovascular Risk Factor, Dietary Modification.

What interventions are being tested in trial NCT02016430?

The interventions under investigation include: MeLT Dietary intervention (BEHAVIORAL), TLC Dietary intervention (BEHAVIORAL), MeLT dietary intervention with TMAO (BEHAVIORAL).

Who is sponsoring clinical trial NCT02016430?

This trial is sponsored by The Cleveland Clinic, which has 688 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT02016430 being conducted?

This trial has 1 study location across Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Similar trials for Cardiovascular Risk Factor

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT02016430's enrollment target sits among peer trials

170 9th of 31 higher than 23 of 31 other Cardiovascular Risk Factor trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Cardiovascular Risk Factor trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT02016430, the US trial registry maintained by the National Library of Medicine. NCT02016430 (mid enrollment · single site footprint · recruiting) retrieved and formatted by PlainTrial, see methodology.