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Life sciences · Interventional Study
ClinicalTrials.gov · September 17, 2026
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Interventional Study.
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Registry record from ClinicalTrials.gov (NCT03924778). This is a study registration, not published results. Lead sponsor: H. Lee Moffitt Cancer Center and Research Institute. Recruitment status: NOT_YET_RECRUITING. Phase: NA. Study type: INTERVENTIONAL. Enrollment: 28 participants (ESTIMATED). Conditions: Obesity. Interventions: BEHAVIORAL: DASH diet; BEHAVIORAL: standard American diet. Primary outcome measures: Mean Weight Change of Participants , Baseline to day 28; Mean Weight Change of Participants , Day 28 to Day 42; Mean Weight Change of Participants , Baseline to day 42; Diet-specific changes in secondary bile acid , Baseline to day 28; Diet-specific changes in secondary bile acid , day 28 to day 42; Diet-specific changes in secondary bile acid , baseline to day 42; Diet-specific changes in inflammatory marker , baseline to day 28; Diet-specific changes in inflammatory marker , day 28 to day 42; Diet-specific changes in inflammatory marker , baseline to day 42; Diet-specific changes in short chain fatty acids , baseline to day 28; Diet-specific changes in short chain fatty acids , day 28 to day 42; Diet-specific changes in short chain fatty acids , baseline to day 42. Brief summary: The investigators will conduct a 2-arm randomized controlled pilot, feasibility feeding study in which 28 participants will be randomized to receive either a calorie-restricted Dietary Approaches to Stop Hypertension (DASH) diet or a calorie-restricted standard American diet provided by the study for 4 weeks. Participants will be non-Hispanic black or white, generally healthy females (14 black, 14 white). The investigators will collect fecal samples at multiple time points before, during, and after the dietary intervention to analyze for changes in the gut microbiota and functional-level metabolic products. This work will be led by an interdisciplinary team including expertise in bio-behavioral science, microbiology, nutrition science, bioinformatics, and biostatistics all with cross-cutting expertise in health disparities, prevention research, nutrition, the gut microbiota, inflammation and other biomarkers. The rationale for the proposed research is that once the interactions between race, diet, and the gut microbiota are more fully understood, targeted diet modifications may provide new and innovative approaches for the prevention and treatment of obesity and obesity-related diseases.