Gut Flora Metabolite Reduction After Dietary Intervention (GRADY)
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorThe Cleveland Clinic
About this trial
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 criteria
Qualifiers
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.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- MeLT Dietary intervention
- TLC Dietary intervention
- MeLT dietary intervention with TMAO
Treatment groups
170 Participants
are divided into 3 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov