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
This trial accepts healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
MeLT Dietary intervention
BehavioralMediterranean diet containing food with low TMAO content.
TLC Dietary intervention
BehavioralStandard American Heart Association (AHA) recommendations for dietary counseling.
MeLT dietary intervention with TMAO
BehavioralMediterranean diet containing food with low TMAO content with TMAO levels provided to the subject for guidance.
Treatment groups
170 Participants
are divided into 3 treatment groupsGroup A: MeLT Dietary interventionExperimental treatment 1 intervention
Group B: TLC Dietary interventionExperimental treatment 1 intervention
Group C: MeLT dietary intervention with TMAOExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Change in TMAO level
The change in TMAO concentration measured in blood samples
Time frame
From baseline to 12 weeks follow-upSponsors and contacts
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Source ClinicalTrials.gov