Gut Flora Metabolite Reduction After Dietary Intervention (GRADY)
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.
Conditions:
๐Ÿฆ  Dietary Modification ๐Ÿฆ  Cardiovascular Risk Factor
๐Ÿ—“๏ธ Study Start (Actual) 4 April 2014
๐Ÿ—“๏ธ Primary Completion (Estimated) December 2025
โœ… Study Completion (Estimated) December 2026
๐Ÿ‘ฅ Enrollment (Estimated) 150
๐Ÿ”ฌ Study Type INTERVENTIONAL
๐Ÿ“Š Phase NA
Locations:
๐Ÿ“ Cleveland, Ohio, United States

๐Ÿ“‹ Eligibility Criteria

Description

    Inclusion Criteria:

      Inclusion Criteria:

      • * Men and women age 18 years or above.
      • * Elevated TMAO metabolizers (\>5 ยตM) based on screening test and/or eGFR \< 60 at most recent measurement.
      • * Willing to remain on aspirin or able to be off aspirin or aspirin products for 1 week prior to starting the study and staying on the same aspirin regimen during the duration of the study.
      • * Willing to sign the consent form and follow the study protocol, which includes a 12-week dietary modification.
      • Inclusion Criteria:

        • * Men and women age 18 years or above.
        • * Willing to remain on aspirin or able to be off aspirin or aspirin products for 1 week prior to starting the study and staying on the same aspirin regimen during the duration of the study.
        • * Willing to sign the consent form and follow the study protocol.
        • * eGFR values ranging from 16-59
        • Inclusion Criteria:

          • * Men and women age 18 years or above.
          • * Willing to remain on aspirin or able to be off aspirin or aspirin products for 1 week prior to starting the study and staying on the same aspirin regimen during the duration of the study.
          • * Willing to sign the consent form and follow the study protocol.
          • Exclusion Criteria (all cohorts):
          • * 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
Ages Eligible for Study: 18 Years to N/A (ADULT, OLDER_ADULT)
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: Yes

๐Ÿ—“๏ธ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

  • First Submitted 15 December 2013
  • First Submitted that Met QC Criteria 19 December 2013
  • First Posted 20 December 2013

Study Record Updates

  • Last Update Submitted that Met QC Criteria 27 October 2023
  • Last Update Posted 30 October 2023
  • Last Verified October 2023