Gut Flora Metabolite Reduction After Dietary Intervention (GRADY)

Launched by THE CLEVELAND CLINIC · Dec 19, 2013

Keywords

ClinConnect Summary

The GRADY trial is studying how changes in diet can affect levels of a substance called trimethylamine-N-oxide (TMAO) in the body, which is linked to heart health. Researchers want to see if by modifying what people eat, they can lower TMAO levels and potentially reduce cardiovascular risks.

To participate in this study, you need to be at least 18 years old and have elevated TMAO levels or certain kidney function measures. All participants must be willing to stick to a specific dietary plan for 12 weeks and manage their aspirin use during the study. It’s important to note that those with serious health conditions or recent antibiotic use are not eligible. If you join, you'll be contributing to important research that could help improve heart health through diet!

Gender

ALL

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 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