CARNIVAL Study: Gut Flora Dependent Metabolism of Dietary CARNItine and Phosphatidylcholine and CardioVAscuLar Disease
Launched by THE CLEVELAND CLINIC · Nov 16, 2012
Trial Information
Current as of June 26, 2025
Enrolling by invitation
Keywords
ClinConnect Summary
The principal goal for the study is to examine the role gut flora plays in modulating metabolism of dietary trimethylamine nutrients in humans. We have recently shown that dietary intake of two trimethylamines abundant in animal products, carnitine and the choline group of phosphatidylcholine (PC), are mechanistically linked to cardiovascular disease risk. We wish to further explore the metabolism of these nutrients in humans, and to test the hypothesis that the intestinal micro flora (gut flora) plays a critical role in generation of metabolites from dietary carnitine and choline/PC linked...
Gender
ALL
Eligibility criteria
- Inclusion Criteria:
- • Men and women age 18 years or above.
- • Able to provide informed consent and comply with study protocol
- Exclusion Criteria:
- • Significant chronic illness or end-organ dysfunction, including known history of heart failure, renal failure, pulmonary disease, hematologic diseases or pregnancy.
- • Active infection or received antibiotics within 2 months of study enrollment
- • Use of Over-The-Counter (OTC) probiotic within past 2 months, or ingestion of yogurt within past 7 days
- • Chronic gastrointestinal disorders, or intolerance to probiotic therapy
- • Having undergone Bariatric procedures or surgeries such as gastric banding or bypass
About The Cleveland Clinic
The Cleveland Clinic is a renowned nonprofit academic medical center based in Cleveland, Ohio, recognized for its commitment to advancing healthcare through innovative research and clinical excellence. As a leading sponsor of clinical trials, the Cleveland Clinic leverages its multidisciplinary expertise and state-of-the-art facilities to conduct groundbreaking studies aimed at improving patient outcomes across a wide range of medical conditions. With a strong emphasis on patient-centered care, the institution fosters collaboration among researchers, clinicians, and patients to explore new treatments and therapies, contributing significantly to the global body of medical knowledge.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Cleveland, Ohio, United States
Patients applied
Trial Officials
Stanley L Hazen, MD, PhD
Principal Investigator
The Cleveland Clinic
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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