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

Dietary Modification Clinical Trial

— CARNIVAL  

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT01731236
• Other study ID #: 10-544
• Status: Enrolling by invitation
• Phase: Early Phase 1
• Start date: February 11, 2011
• Est. completion date: December 2026

Study information

• Verified date: October 2023
• Source: The Cleveland Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 100
• Est. completion date: December 2026
• Est. primary completion date: December 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cardiovascular Diseases
• Dietary Modification

Intervention

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

Country	Name	City	State
United States	Cleveland Clinic	Cleveland	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
The Cleveland Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Primary Outcome Measure	Plasma levels of carnitine and multiple gut flora metabolites	December 2017
Secondary	Secondary Outcome Measures	Alterations in plasma levels of cardio-metabolic risk factors.	December 2017