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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

EARLY_PHASE1

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-02-11

Study Completion Date

2026-12-31

Brief Summary

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

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Detailed Description

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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.

Conditions

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Dietary Modification

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Carnitine (No antibiotics, No aspirin)

L-Carnitine 500 mg capsule by mouth, twice daily for 2 months. No aspirin for 1 month prior to starting study and remains off aspirin during study.

Group Type ACTIVE_COMPARATOR

Carnitine

Intervention Type DIETARY_SUPPLEMENT

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

Choline (No Antibiotics, No aspirin)

Choline 500 mg capsule by mouth, twice daily for 2 months. No aspirin for 1 month prior to starting study and remains off aspirin during study.

Group Type ACTIVE_COMPARATOR

Choline

Intervention Type DIETARY_SUPPLEMENT

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

Antibiotics

Antibiotics (Ciprofloxacin, Vancomycin, Metronidazole and Neomycin) Drug: Ciprofloxacin 500 mg, po, twice daily for 7 days (Other Names: Cipro)

Drug: Metronidazole 500 mg, po, twice daily for 7 days (Other Names: Flagyl, Noritate, Rosadan, Vandazole, Flagyl ER, Vitazol)

Drug: Vancomycin 125 mg, po, 4 times daily for 7 days (Other Names: Vancocin, Vancocin HCl, Pulvules, Vancoled, Novaplus, PremierPro Rx, Vancomycin HCl)

Drug: Neomycin 1 gram, po, four times daily for 7 days (Other Names: Aminoglycoside)

Group Type ACTIVE_COMPARATOR

Antibiotics

Intervention Type DRUG

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

Choline and Aspirin

Choline supplement 500 mg capsule by mouth, twice daily for 2 months Drug: aspirin 81 mg by mouth, daily for 3 months (on aspirin for 1 month prior to starting study and 2 months with Choline supplementation during study)

Other Names:

Ecotrin, Bufferin, Ascriptin, Fasprin, Norwich Aspirin, Durlaza, Bayer Genuine Aspirin, Genacote, Bayer, Halfprin, Aspirtab, Aspir Low, Aspir-Trin

Group Type ACTIVE_COMPARATOR

Choline and Aspirin

Intervention Type DRUG

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).

Carnitine and Aspirin

Carnitine supplement 500 mg capsule by mouth, twice daily for 2 months Drug: aspirin 81 mg by mouth, daily for 3 months (on aspirin for 1 month prior to starting study and 2 months with Carnitine supplementation during study)

Other Names:

Ecotrin, Bufferin, Ascriptin, Fasprin, Norwich Aspirin, Durlaza, Bayer Genuine Aspirin, Genacote, Bayer, Halfprin, Aspirtab, Aspir Low, Aspir-Trin

Group Type ACTIVE_COMPARATOR

Carnitine and Aspirin

Intervention Type DRUG

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).

Interventions

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Carnitine

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

Intervention Type DIETARY_SUPPLEMENT

Choline

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

Intervention Type DIETARY_SUPPLEMENT

Antibiotics

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

Intervention Type 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).

Intervention Type 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).

Intervention Type DRUG

Other Intervention Names

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Ciprofloxacin, Flagyl, Vancomycin, and Neomycin aspirin aspirin

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes