Gut Flora Metabolite Reduction After Dietary Intervention (GRADY)
Recruiting
N/AInterventional Study
Dietary ModificationCardiovascular Risk Factor
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Healthy Volunteers Welcome
You do not need to have the condition being studied to take part.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 and older
Sex
Any
Study type
Interventional
Purpose
Treatment
Participants needed
170 (estimated)
Sponsor
The Cleveland Clinic · Other
Who this trial is looking for
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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.
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Eligibility Criteria
Inclusion Criteria:
Cohort 1 Inclusion criteria:
* Men and women age 18 years or above.
* Elevated TMAO metabolizers (\>5 µM) based on screening test and/or eGFR \< 60 at most recent measurement.
* Willing to remain on aspirin or able to be off aspirin or aspirin products for 1 week prior to start…
Inclusion Criteria:
Cohort 1 Inclusion criteria:
* Men and women age 18 years or above.
* Elevated TMAO metabolizers (\>5 µM) based on screening test and/or eGFR \< 60 at most recent measurement.
* Willing to remain on aspirin or able to be off aspirin or aspirin products for 1 week prior to starting the study and staying on the same aspirin regimen during the duration of the study.
* Willing to sign the consent form and follow the study protocol, which includes a 12-week dietary modification.
Cohort 2 Inclusion criteria:
* Men and women age 18 years or above.
* Willing to remain on aspirin or able to be off aspirin or aspirin products for 1 week prior to starting the study and staying on the same aspirin regimen during the duration of the study.
* Willing to sign the consent form and follow the study protocol.
* eGFR values ranging from 16-59
Cohort 3 Inclusion criteria:
* Men and women age 18 years or above.
* Willing to remain on aspirin or able to be off aspirin or aspirin products for 1 week prior to starting the study and staying on the same aspirin regimen during the duration of the study.
* Willing to sign the consent form and follow the study protocol.
Exclusion Criteria (all cohorts):
* Significant chronic illness or end-organ dysfunction, including known history of uncompensated heart failure, renal failure, pulmonary disease, hematologic diseases.
* Active infection or received antibiotics within 2 months of study enrollment
* Use of over-the-counter probiotic within past month, or ingestion of yogurt within past 7 days
* Having undergone bariatric procedures or surgeries such as gastric banding or bypass.
* Pregnancy.
* Any condition which, in the judgment of the Investigator, would place a patient at undue risk by being enrolled in the trial, or cause inability to comply with the trial
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