Gut flora metabolism of phosphatidylcholine promotes cardiovascular disease.
Zeneng Wang, Elizabeth Klipfell, Brian J Bennett...
https://pubmed.ncbi.nlm.nih.gov/21475195Actively Recruiting
Phase Not Applicable
Age: 18Years +
All Genders
Healthy Volunteers
ID02016430
Gut Flora Metabolite Reduction After Dietary Intervention (GRADY)
Led by The Cleveland Clinic · Updated on 2025-10-29
170
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying the connection between gut bacteria metabolism, specifically the production of trimethylamine-N-oxide (TMAO), and cardiovascular risk. This pilot study aims to understand how dietary changes might reduce TMAO levels in people who have elevated amounts of this metabolite. The study focuses on how different diets affect TMAO generation from gut flora using special labeled compounds. Participants are assigned randomly to one of several dietary groups: the Mediterranean Low-TMAO (MeLT) diet, the Therapeutic Lifestyle Changes (TLC) diet following American Heart Association guidelines, or the MeLT diet with feedback on their TMAO levels. These dietary interventions last for 12 weeks. Some groups receive information about their TMAO levels to guide their dietary choices. During the study, participants follow the assigned diet for 12 weeks while researchers measure changes in their TMAO levels from the start to the end of the period. Assessments include blood tests using stable-isotope-labeled nutrients to track TMAO production. Participants must maintain consistent aspirin use or abstinence as required. The study also monitors kidney function and excludes those with recent infections, recent probiotic or yogurt intake, certain surgeries, or serious health conditions. The total participation time is at least 12 weeks for dietary modification and follow-up.
CONDITIONS
Brief Title
Gut Flora Metabolite Reduction After Dietary Intervention (GRADY)
Who Can Participate
Age: 18Years +
All Genders
Healthy Volunteers
Eligibility Criteria
You may qualify if you...
- Men and women age 18 years or above
- Elevated TMAO metabolizers (>5 BCM) 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 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
- eGFR values ranging from 16-59 (Cohort 2)
- Men and women age 18 years or above (Cohorts 2 and 3)
- Willing to sign the consent form and follow the study protocol (Cohorts 2 and 3)
You will not qualify if you...
- 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 would place a patient at undue risk by being enrolled in the trial or cause inability to comply with the trial
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Outpatient Treatment
Duration - 12 weeks
Participants follow one of three dietary interventions to reduce TMAO levels through tailored diet changes.
Regular visits during the 12-week dietary modification period
Follow-up
Duration - Up to 12 weeks post-intervention
Participants are monitored for changes in TMAO levels after completing the dietary intervention.
1 follow-up visit (in-person)
Trial Site Locations
Total: 1 location
1
Cleveland Clinic
Cleveland, Ohio, United States, 44195
Actively Recruiting
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Research Team
J
Jennifer Wilcox
T
Timothy Engelman, LPN
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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Published Research Related To This Trial
Intestinal microbiota metabolism of L-carnitine, a nutrient in red meat, promotes atherosclerosis.
Robert A Koeth, Zeneng Wang, Bruce S Levison...
https://pubmed.ncbi.nlm.nih.gov/23563705Prospective study on dietary intakes of folate, betaine, and choline and cardiovascular disease risk in women.
G W Dalmeijer, M R Olthof, P Verhoef...
https://pubmed.ncbi.nlm.nih.gov/17375117Usual choline and betaine dietary intake and incident coronary heart disease: the Atherosclerosis Risk in Communities (ARIC) study.
Aurelian Bidulescu, Lloyd E Chambless, Anna Maria Siega-Riz...
https://pubmed.ncbi.nlm.nih.gov/17629908Intestinal microbial metabolism of phosphatidylcholine and cardiovascular risk.
W H Wilson Tang, Zeneng Wang, Bruce S Levison...
https://pubmed.ncbi.nlm.nih.gov/23614584