Gut Flora Metabolite Reduction After Dietary Intervention (GRADY)
NCT ID: NCT02016430
Last Updated: 2025-10-29
Study Results
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Basic Information
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RECRUITING
NA
170 participants
INTERVENTIONAL
2014-04-04
2026-12-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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MeLT Dietary intervention
Mediterranean Low-TMAO (MeLT) diet. Used in cohorts 1, 2 and 3.
MeLT Dietary intervention
Mediterranean diet containing food with low TMAO content.
TLC Dietary intervention
Therapeutic Lifestyle Changes (TLC) diet. Used in cohorts 1, 2 and 3.
TLC Dietary intervention
Standard American Heart Association (AHA) recommendations for dietary counseling.
MeLT dietary intervention with TMAO
Mediterranean Low TMAO diet with TMAO levels reported. Used in cohort 1 only.
MeLT dietary intervention with TMAO
Mediterranean diet containing food with low TMAO content with TMAO levels provided to the subject for guidance.
Interventions
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MeLT Dietary intervention
Mediterranean diet containing food with low TMAO content.
TLC Dietary intervention
Standard American Heart Association (AHA) recommendations for dietary counseling.
MeLT dietary intervention with TMAO
Mediterranean diet containing food with low TMAO content with TMAO levels provided to the subject for guidance.
Eligibility Criteria
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Inclusion Criteria
* Elevated TMAO metabolizers (\>5 µM) 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.
* 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
* 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
* 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
18 Years
ALL
Yes
Sponsors
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The Cleveland Clinic
OTHER
Responsible Party
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Wilson Tang
Staff Cellular and Molecular Medicine and Cardiovascular Medicine
Principal Investigators
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W. H. Wilson Tang, MD
Role: PRINCIPAL_INVESTIGATOR
The Cleveland Clinic
Stanley L. Hazen, MD
Role: PRINCIPAL_INVESTIGATOR
The Cleveland Clinic
Locations
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Cleveland Clinic
Cleveland, Ohio, United States
Countries
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Central Contacts
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Facility Contacts
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References
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Wang Z, Klipfell E, Bennett BJ, Koeth R, Levison BS, Dugar B, Feldstein AE, Britt EB, Fu X, Chung YM, Wu Y, Schauer P, Smith JD, Allayee H, Tang WH, DiDonato JA, Lusis AJ, Hazen SL. Gut flora metabolism of phosphatidylcholine promotes cardiovascular disease. Nature. 2011 Apr 7;472(7341):57-63. doi: 10.1038/nature09922.
Koeth RA, Wang Z, Levison BS, Buffa JA, Org E, Sheehy BT, Britt EB, Fu X, Wu Y, Li L, Smith JD, DiDonato JA, Chen J, Li H, Wu GD, Lewis JD, Warrier M, Brown JM, Krauss RM, Tang WH, Bushman FD, Lusis AJ, Hazen SL. Intestinal microbiota metabolism of L-carnitine, a nutrient in red meat, promotes atherosclerosis. Nat Med. 2013 May;19(5):576-85. doi: 10.1038/nm.3145. Epub 2013 Apr 7.
Dalmeijer GW, Olthof MR, Verhoef P, Bots ML, van der Schouw YT. Prospective study on dietary intakes of folate, betaine, and choline and cardiovascular disease risk in women. Eur J Clin Nutr. 2008 Mar;62(3):386-94. doi: 10.1038/sj.ejcn.1602725. Epub 2007 Mar 21.
Bidulescu A, Chambless LE, Siega-Riz AM, Zeisel SH, Heiss G. Usual choline and betaine dietary intake and incident coronary heart disease: the Atherosclerosis Risk in Communities (ARIC) study. BMC Cardiovasc Disord. 2007 Jul 13;7:20. doi: 10.1186/1471-2261-7-20.
Tang WH, Wang Z, Levison BS, Koeth RA, Britt EB, Fu X, Wu Y, Hazen SL. Intestinal microbial metabolism of phosphatidylcholine and cardiovascular risk. N Engl J Med. 2013 Apr 25;368(17):1575-84. doi: 10.1056/NEJMoa1109400.
Other Identifiers
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13-863
Identifier Type: -
Identifier Source: org_study_id
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