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

This study is enrolling participants by invitation only.
Sponsor:
Information provided by (Responsible Party):
The Cleveland Clinic
ClinicalTrials.gov Identifier:
NCT01731236
First received: January 23, 2012
Last updated: November 16, 2012
Last verified: November 2012
  Purpose

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


Condition Intervention Phase
Nutrition
Other: Antibiotic/Probiotic
Phase 0

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: CARNIVAL Study: Gut Flora Dependent Metabolism of Dietary CARNItine and cardioVAscuLar Disease

Resource links provided by NLM:


Further study details as provided by The Cleveland Clinic:

Primary Outcome Measures:
  • Primary Outcome Measure [ Designated as safety issue: No ]
    Plasma levels of carnitine and multiple gut flora metabolites


Secondary Outcome Measures:
  • Secondary Outcome Measures: [ Designated as safety issue: No ]
    alterations in plasma levels of cardio-metabolic risk factors.


Estimated Enrollment: 36
Study Start Date: July 2010
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Group 1
Group 1 Antibiotics(Ciprofloxacin, Flagyl, Vancomycin, Neomycin)/probioitic:
Other: Antibiotic/Probiotic

Antibiotic cocktail(Ciprofloxaicin, Flagyl, Vancomycin, Neomycin)/yogurt as follows:

Group 1: antibiotics for 1 week, followed by probiotics for 3 weeks; Group 2: antibiotics for 1 week, followed by no probiotics for 3 weeks; Group 3: no antibiotics for 1 week, followed by probiotics for 3 weeks;

Active Comparator: Group 2
Group 2 Antibiotics (Ciprofloxaicin, Flagyl, Vancomycin, Neomycin)/no-probiotic:
Other: Antibiotic/Probiotic

Antibiotic cocktail(Ciprofloxaicin, Flagyl, Vancomycin, Neomycin)/yogurt as follows:

Group 1: antibiotics for 1 week, followed by probiotics for 3 weeks; Group 2: antibiotics for 1 week, followed by no probiotics for 3 weeks; Group 3: no antibiotics for 1 week, followed by probiotics for 3 weeks;

Active Comparator: Group 3
Group 3 (no-Antibiotics/probiotic):
Other: Antibiotic/Probiotic

Antibiotic cocktail(Ciprofloxaicin, Flagyl, Vancomycin, Neomycin)/yogurt as follows:

Group 1: antibiotics for 1 week, followed by probiotics for 3 weeks; Group 2: antibiotics for 1 week, followed by no probiotics for 3 weeks; Group 3: no antibiotics for 1 week, followed by probiotics for 3 weeks;


Detailed Description:

The principal goal for the study is to examine the role gut flora plays in modulating metabolism of dietary carnitine in humans. We hypothesize that levels of carnitine and its metabolites, trimethylamine (TMA), trimethylamine N-oxide (TMAO), and other gut flora, can be detected in human plasma and urine, and changes in response to dietary intake of red meats (Koeth et al, 2010, unpublished data). We also hypothesize that metabolism of carnitine may differ between men and women, and between those with low versus high cardiovascular risk factors (e.g. diabetes mellitus, chronic kidney disease) and metabolic syndrome (insulin resistance, dyslipidemia, obesity, hypertension). We further hypothesize that specific metabolites of carnitine are produced in a fashion dependent upon the action of intestinal microflora (gut flora), and can be reduced by transient suppression or modulation of gut flora via short-term broad spectrum antibiotic therapy, or by reconstitution of microflora composition via probiotic therapy, in healthy subjects.

The purpose of this pilot study is to establish the methodology and pursue further understanding of the human metabolism of dietary carnitine and factors that may influence carnitine metabolism in humans. Findings of these pilot observations are important in providing proof-of-concept, and in determining the best ways to identify these potentially vulnerable subjects for future intervention studies.

This is a prospective, randomized, 3-Arm study of 4-week duration per subject.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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 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 proceedures or surgeries such as gastric banding or bipass
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01731236

Locations
United States, Ohio
Cleveland Clinic
Cleveland, Ohio, United States, 44195
Sponsors and Collaborators
The Cleveland Clinic
  More Information

No publications provided

Responsible Party: The Cleveland Clinic
ClinicalTrials.gov Identifier: NCT01731236     History of Changes
Other Study ID Numbers: 10-544
Study First Received: January 23, 2012
Last Updated: November 16, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by The Cleveland Clinic:
Carnitine metabolism
gut flora

Additional relevant MeSH terms:
Cardiovascular Diseases
Anti-Bacterial Agents
Antibiotics, Antitubercular
Carnitine
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Antitubercular Agents
Vitamin B Complex
Vitamins
Micronutrients
Growth Substances
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on September 18, 2014