CARNIVAL Study: Gut Flora Dependent Metabolism of Dietary CARNItine and Phosphatidylcholine and cardioVAscuLar Disease
| Status: | Enrolling by invitation |
|---|---|
| Conditions: | Food Studies, Peripheral Vascular Disease |
| Therapuetic Areas: | Cardiology / Vascular Diseases, Pharmacology / Toxicology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 7/19/2018 |
| Start Date: | July 2010 |
| End Date: | June 2020 |
The principal goal for the study is to examine the role gut flora plays in modulating
metabolism of dietary carnitine and choline in humans.
metabolism of dietary carnitine and choline in humans.
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 to cardiometabolic disease. We
further hypothesize that the production of specific metabolites of carnitine and choline/PC
are influenced by the composition of gut flora, and these may be altered by the preceding
dietary patterns of the subjects. We therefore wish to test whether dietary supplementation
with carnitine and/or choline alters the metabolism of carnitine and choline/PC in subjects.
We also hypothesize that transient suppression or modulation of gut flora via short-term
broad spectrum antibiotic therapy, or by reconstitution of micro flora composition via
probiotic therapy, in healthy subjects, can alter the metabolism of carnitine and choline/PC.
We will also examine the impact of low dose aspirin on these pathways by examining subjects
before versus after taking aspirin.
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 to cardiometabolic disease. We
further hypothesize that the production of specific metabolites of carnitine and choline/PC
are influenced by the composition of gut flora, and these may be altered by the preceding
dietary patterns of the subjects. We therefore wish to test whether dietary supplementation
with carnitine and/or choline alters the metabolism of carnitine and choline/PC in subjects.
We also hypothesize that transient suppression or modulation of gut flora via short-term
broad spectrum antibiotic therapy, or by reconstitution of micro flora composition via
probiotic therapy, in healthy subjects, can alter the metabolism of carnitine and choline/PC.
We will also examine the impact of low dose aspirin on these pathways by examining subjects
before versus after taking aspirin.
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
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