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.

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