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Testing two diets and their effect on gut bacteria in adults with obesity

Compares a DASH diet with a standard American diet in women with obesity.

Plain-language title generated from the registry record
Registry title: Modifying Diet to Improve Gut Microbiome

Key facts

Where
Tampa, United StatesSee the site

Where in United States

  • Moffit Cancer CenterTampa, United StatesNo longer taking part

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Trial details

Who runs it
H. Lee Moffitt Cancer Center and Research Institute
Trial code
NCT03924778
Record updated
17 September 2026
Original description
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.Read full original descriptionShow less

Modifying Diet and the Gut Microbiota to Reduce Obesity and Health Disparities

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.

Inclusion: female; non-Hispanic, black or white; age 19-65 years; BMI >= 30 kg/m\^2; able to visit Bionutrition Unit daily.

Exclusion: antibiotic or probiotic use in the previous 90 days; gastrointestinal (GI) conditions i.e., irritable bowel, diverticulitis, peptic ulcers, Crohn's, GI cancers, and adenatomous polyps; major medical conditions (e.g., renal disease, diabetes, cancer); tobacco use; heavy alcohol consumption.

ClinicalTrials.gov NCT03924778