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Dietary Intervention for Cardiovascular Risk (GRADY Trial)

N/A
Recruiting
Led By W. H. Wilson Tang, MD
Research Sponsored by The Cleveland Clinic
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Willing to remain on aspirin or able to be off aspirin or aspirin products for 1 week prior to starting study and staying on the same aspirin regimen during the duration of the 12-week study.
Men and women age 18 years or above.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from baseline to 12 weeks follow-up
Awards & highlights

GRADY Trial Summary

This trial investigates whether or not dietary intervention can reduce levels of TMAO, which has been associated with cardiovascular risk.

Who is the study for?
The GRADY trial is for men and women over 18 who are willing to modify their diet for 12 weeks and can either stay on aspirin or avoid it a week before and during the study. It's not suitable for those with recent infections, antibiotic use within two months, past stomach surgeries, pregnancy, significant chronic illnesses, or recent probiotic/yogurt consumption.Check my eligibility
What is being tested?
This study tests if changing your diet can affect levels of TMAO, a gut flora metabolite linked to heart disease risk. Participants will try one of three diets: MeLT Diet alone; MeLT Diet plus TMAO; or TLC (Therapeutic Lifestyle Changes) Diet.See study design
What are the potential side effects?
Since this trial involves dietary changes rather than medication, side effects may include gastrointestinal discomfort due to new foods or eating patterns but are generally expected to be minimal.

GRADY Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I can stay on or stop taking aspirin as needed for the study.
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I am 18 years old or older.

GRADY Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from baseline to 12 weeks follow-up
This trial's timeline: 3 weeks for screening, Varies for treatment, and from baseline to 12 weeks follow-up for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in TMAO level

GRADY Trial Design

3Treatment groups
Experimental Treatment
Group I: TLC Dietary interventionExperimental Treatment1 Intervention
Therapeutic Lifestyle Changes (TLC) diet. Used in cohorts 1, 2 and 3.
Group II: MeLT dietary intervention with TMAOExperimental Treatment1 Intervention
Mediterranean Low TMAO diet with TMAO levels reported. Used in cohort 1 only.
Group III: MeLT Dietary interventionExperimental Treatment1 Intervention
Mediterranean Low-TMAO (MeLT) diet. Used in cohorts 1, 2 and 3.

Find a Location

Who is running the clinical trial?

The Cleveland ClinicLead Sponsor
1,021 Previous Clinical Trials
1,365,580 Total Patients Enrolled
3 Trials studying Cardiovascular Risk
136 Patients Enrolled for Cardiovascular Risk
W. H. Wilson Tang, MDPrincipal InvestigatorThe Cleveland Clinic
7 Previous Clinical Trials
1,791 Total Patients Enrolled
1 Trials studying Cardiovascular Risk
86 Patients Enrolled for Cardiovascular Risk
Stanley L. Hazen, MDPrincipal InvestigatorThe Cleveland Clinic

Media Library

MeLT Dietary intervention (Other) Clinical Trial Eligibility Overview. Trial Name: NCT02016430 — N/A
Cardiovascular Risk Research Study Groups: MeLT Dietary intervention, MeLT dietary intervention with TMAO, TLC Dietary intervention
Cardiovascular Risk Clinical Trial 2023: MeLT Dietary intervention Highlights & Side Effects. Trial Name: NCT02016430 — N/A
MeLT Dietary intervention (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02016430 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many participants are involved in the research endeavor?

"Affirmative. The clinical trial is currently recruiting participants, as evidenced by the information available on clinicaltrials.gov. This study began recruitment efforts on April 4th 2014 and was recently refreshed on September 28th 2022; 100 volunteers are required from a single site for participation in this research program."

Answered by AI

Are there any opportunities for individuals to partake in this trial?

"As recorded on clinicaltrials.gov, this research endeavour is now open to participants. This trial was initially opened for enrollment on April 4th, 2014 and its information has been refined as recently as September 28th 2022."

Answered by AI
Recent research and studies
~22 spots leftby Dec 2025