Gut Flora Metabolite Reduction After Dietary Intervention (GRADY) (GRADY)
|Dietary Modification Cardiovascular Risk Factor||Behavioral: MeLT Dietary intervention Behavioral: TLC Dietary intervention Behavioral: MeLT dietary intervention with TMAO||Phase 1 Phase 2|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Gut Flora Metabolite Reduction After Dietary Intervention (GRADY)|
- Change in TMAO level [ Time Frame: From baseline to 12 weeks follow-up ]
|Study Start Date:||December 2013|
|Estimated Study Completion Date:||December 2018|
|Estimated Primary Completion Date:||December 2018 (Final data collection date for primary outcome measure)|
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.
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:
- To investigate the proportion of subjects with persistently elevated circulating TMAO levels.
- 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.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT02016430
|Contact: Timothy Engelmanfirstname.lastname@example.org|
|United States, Ohio|
|Cleveland, Ohio, United States, 44195|
|Contact: Timothy Engelman 216-636-6153 email@example.com|
|Principal Investigator: W. H. Wilson Tang, MD|
|Principal Investigator: Stanley L. Hazen, MD|
|Principal Investigator:||W. H. Wilson Tang, MD||The Cleveland Clinic|
|Principal Investigator:||Stanley L. Hazen, MD||The Cleveland Clinic|