Gut Flora Metabolite Reduction After Dietary Intervention (GRADY)
The Cleveland Clinic
170 participants
Apr 4, 2014
INTERVENTIONAL
Conditions
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.
Eligibility
Inclusion Criteria11
- 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.
- 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
- 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 Criteria6
- 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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Interventions
Mediterranean diet containing food with low TMAO content.
Standard American Heart Association (AHA) recommendations for dietary counseling.
Mediterranean diet containing food with low TMAO content with TMAO levels provided to the subject for guidance.
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT02016430