This clinical trial examines the effect of a diet-specific intervention on the gut microbiota of a racially diverse sample of adults. The dietary approaches to stop hypertension (DASH) dietary pattern, currently widely recommended for improved heart health, is rich in whole grains, fruits, vegetables and low-fat dairy and represents a higher fiber intake than the standard American diet. Eating a DASH diet may reduce the risk of some types of colorectal cancer.
Additional locations may be listed on ClinicalTrials.gov for NCT04538482.
Locations matching your search criteria
United States
Florida
Tampa
Moffitt Cancer CenterStatus: Active
Contact: Tiffany Carson
Phone: 813-745-4944
PRIMARY OBJECTIVE:
I. Examine the effect of a diet-specific (dietary approaches to stop hypertension [“DASH”] or “standard American”) 4-week intervention on the gut microbiota of a racially diverse sample of adults and test for race effects.
II. Evaluate diet-specific effects on functional markers of the gut microbiota including production of secondary bile acids (e.g. lithocholic acid, deoxycholic acid), short chain fatty acids (SCFAs) (e.g, acetate, butyrate, propionate), and inflammatory markers (e.g. calprotectin, interlukin-6 [IL-6]) and test for race effects.
OUTLINE: Participants receive a standard American diet for 1 week. Participants are then randomized to 1 of 2 arms.
ARM I: Participants receive the DASH diet for 4 weeks.
ARM II: Participants receive a standard American diet for 4 weeks.
After completion of study treatment, patients are followed up at day 42 and day 49.
Trial PhaseNo phase specified
Trial Typeprevention
Lead OrganizationMoffitt Cancer Center
Principal InvestigatorTiffany Carson
