Gut Flora Metabolite Reduction After Dietary Intervention (GRADY)

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2013 by The Cleveland Clinic
Sponsor:
Information provided by (Responsible Party):
Wilson Tang, The Cleveland Clinic
ClinicalTrials.gov Identifier:
NCT02016430
First received: December 15, 2013
Last updated: December 19, 2013
Last verified: December 2013
  Purpose

Our group has recently identified the association between gut-flora-mediated carnitine and phosphatidylcholine metabolism, specifically trimethylamine-N-oxide (TMAO), and cardiovascular risk. This study investigates the ability for dietary intervention to modulate TMAO levels.


Condition Intervention Phase
Dietary Modification
Cardiovascular Risk Factor
Behavioral: MeLT Dietary intervention
Behavioral: TLC Dietary intervention
Behavioral: MeLT dietary intervention with TMAO
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Gut Flora Metabolite Reduction After Dietary Intervention (GRADY)

Further study details as provided by The Cleveland Clinic:

Primary Outcome Measures:
  • Change in TMAO level [ Time Frame: From baseline to 12 weeks follow-up ] [ Designated as safety issue: No ]

Estimated Enrollment: 90
Study Start Date: December 2013
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: MeLT Dietary intervention
Mediterranean Low-TMAO (MeLT) diet
Behavioral: MeLT Dietary intervention
Mediterranean diet containing food with low TMAO content.
Experimental: TLC Dietary intervention
Therapeutic Lifestyle Changes (TLC) diet
Behavioral: TLC Dietary intervention
Standard American Heart Association (AHA) recommendations for dietary counseling
Experimental: MeLT dietary intervention with TMAO
Mediterranean Low TMAO diet with TMAO levels reported
Behavioral: MeLT dietary intervention with TMAO
Mediterranean diet containing food with low TMAO content with TMAO levels provided to the subject for guidance.

Detailed Description:

This is a pilot human study to characterize the relationship between gut flora-associated TMAO generation and dietary intervention. The investigators hypothesize that tailored dietary interventions may help to reduce the ability for gut flora to generate TMAO in individuals with elevated TMAO levels. Specific aims include:

  1. To investigate the proportion of subjects with persistently elevated circulating TMAO levels.
  2. To compare the amount of TMAO generated from gut flora using stable-isotope-labelled choline, carnitine, and betaine in subjects with elevated versus normal circulating TMAO levels.
  3. To evaluate the effect of dietary interventions on the amount of TMAO generated from gut flora using stable-isotope-labelled choline, carnitine, and betaine in subjects with elevated circulating TMAO levels.
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Men and women age 18 years or above.
  • Elevated TMAO metabolizers (>5 µM) based on screening test.
  • Willing to remain on aspirin or able to be off aspirin or aspirin products for 1 week prior to starting study and staying on the same aspirin regimen during the duration of the 12-week study.
  • Willing to sign consent form or to follow study protocol, which includes 12-week dietary modification.

Exclusion Criteria:

  • Significant chronic illness or end-organ dysfunction, including known history of uncompensated heart failure, renal failure, pulmonary disease, hematologic diseases.
  • Active infection or received antibiotics within 2 months of study enrollment
  • Use of over-the-counter probiotic within past month, or ingestion of yogurt within past 7 days
  • Having undergone bariatric procedures or surgeries such as gastric banding or bypass.
  • Pregnancy.
  • Any condition which, in the judgment of the Investigator, would place a patient at undue risk by being enrolled in the trial, or cause inability to comply with the trial
  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: NCT02016430

Contacts
Contact: Timothy Engelman 216-636-6153 engelmt@ccf.org

Locations
United States, Ohio
Cleveland Clinic Recruiting
Cleveland, Ohio, United States, 44195
Contact: Timothy Engelman    216-636-6153    engelmt@ccf.org   
Principal Investigator: W. H. Wilson Tang, MD         
Principal Investigator: Stanley L. Hazen, MD         
Sponsors and Collaborators
The Cleveland Clinic
Investigators
Principal Investigator: W. H. Wilson Tang, MD The Cleveland Clinic
Principal Investigator: Stanley L. Hazen, MD The Cleveland Clinic
  More Information

Publications:
Responsible Party: Wilson Tang, Staff Cellular and Molecular Medicine and Cardiovascular Medicine, The Cleveland Clinic
ClinicalTrials.gov Identifier: NCT02016430     History of Changes
Other Study ID Numbers: 13-863
Study First Received: December 15, 2013
Last Updated: December 19, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by The Cleveland Clinic:
TMAO
Gut Flora
Dietary Intervention
Choline
Carnitine

ClinicalTrials.gov processed this record on August 18, 2014