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ACTIVE NOT RECRUITING
NCT01731236
EARLY_PHASE1

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

Sponsor: The Cleveland Clinic

View on ClinicalTrials.gov

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.

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

100

Start Date

2011-02-11

Completion Date

2029-12

Last Updated

2026-03-23

Healthy Volunteers

Yes

Interventions

DIETARY_SUPPLEMENT

Carnitine

Group 1: Carnitine supplement for 2 months, No antibiotics, no aspirin for 3 months (1 month prior and during study)

DIETARY_SUPPLEMENT

Choline

Group 2: Choline supplement for 2 months, No antibiotics, no aspirin for 3 months (1 month prior and during study)

DRUG

Antibiotics

Group 3: Carnitine or Choline for 2 months, antibiotic cocktail (Ciprofloxacin, Flagyl, Vancomycin, and Neomycin) for 1 week

DRUG

Choline and Aspirin

Group 4: Choline supplement for 2 months plus aspirin 81 mg for 3 months (1 month prior to starting the study and 2 months during the study).

DRUG

Carnitine and Aspirin

Group 5: Carnitine supplement for 2 months plus aspirin 81 mg for 3 months (1 month prior to starting the study and 2 months during the study).

Locations (1)

Cleveland Clinic

Cleveland, Ohio, United States