CARNIVAL Study: Gut Flora Dependent Metabolism of Dietary CARNItine and Phosphatidylcholine and CardioVAscuLar Disease

Last updated: November 5, 2024
Sponsor: The Cleveland Clinic
Overall Status: Active - Enrolling

Phase

1

Condition

Vascular Diseases

Treatment

Antibiotics

Choline

Carnitine

Clinical Study ID

NCT01731236
10-544
  • Ages > 18
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

The principal goal for the study is to examine the role gut flora plays in modulating metabolism of dietary carnitine and choline in humans.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Men and women age 18 years or above.

  • Able to provide informed consent and comply with study protocol

Exclusion

Exclusion Criteria:

  • Significant chronic illness or end-organ dysfunction, including known history ofheart 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 yogurtwithin past 7 days

  • Chronic gastrointestinal disorders, or intolerance to probiotic therapy

  • Having undergone Bariatric procedures or surgeries such as gastric banding or bypass

Study Design

Total Participants: 100
Treatment Group(s): 5
Primary Treatment: Antibiotics
Phase: 1
Study Start date:
February 11, 2011
Estimated Completion Date:
December 31, 2026

Study Description

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.

Connect with a study center

  • Cleveland Clinic

    Cleveland, Ohio 44195
    United States

    Site Not Available

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