Actively Recruiting
Gut Flora Metabolite Reduction After Dietary Intervention (GRADY)
Led by The Cleveland Clinic · Updated on 2025-10-29
170
Participants Needed
1
Research Sites
660 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Gut Flora Metabolite Reduction After Dietary Intervention (GRADY)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Men and women age 18 years or above
- Elevated TMAO metabolizers (>5 M) based on screening test and/or eGFR < 60 at most recent measurement (Cohort 1)
- Willing to remain on aspirin or able to be off aspirin or aspirin products for 1 week prior to starting the study and stay on the same aspirin regimen during the study
- Willing to sign the consent form and follow the study protocol, including a 12-week dietary modification (Cohort 1)
- Men and women age 18 years or above (Cohort 2 and 3)
- eGFR values ranging from 16-59 (Cohort 2)
- Willing to sign the consent form and follow the study protocol (Cohort 2 and 3)
You will not qualify if you...
- Significant chronic illness or end-organ dysfunction, including 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 probiotics 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 would place the patient at undue risk or cause inability to comply with the trial as judged by the Investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Cleveland Clinic
Cleveland, Ohio, United States, 44195
Actively Recruiting
Research Team
J
Jennifer Wilcox
CONTACT
T
Timothy Engelman, LPN
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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