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RECRUITING NA

Gut Flora Metabolite Reduction After Dietary Intervention (GRADY)

NCT02016430 · View on ClinicalTrials.gov ↗

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.

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

Sponsor

The Cleveland Clinic

607 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT02016430

The ClinicalTrials.gov registry entry for NCT02016430 describes a study currently listed as recruiting. It is categorized as NA, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 170 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is The Cleveland Clinic, which has 607 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT02016430 reports 1 study location spanning 1 distinct geographic area — top geographies include Ohio. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

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). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT02016430?

This trial is sponsored by The Cleveland Clinic, which has 607 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial