Modifying Diet to Improve Gut Microbiome
Starting soon · Not applicable
Conditions studied: Obesity
In brief
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.
Key facts
- Study ID
- NCT03924778
- Run by
- H. Lee Moffitt Cancer Center and Research Institute
- People needed
- 28
- Starts
- 2026-07-01
- Expected to finish
- 2026-08-01
- Last updated by the study team
- 2025-09-10
Who can join
Age: 18 and older. Sex: female. Healthy volunteers: accepted.
You may qualify if…
- female
- non-Hispanic, black or white
- age 19-65 years
- BMI >= 30 kg/m\^2
- able to visit Bionutrition Unit daily
You may not qualify if…
- gastrointestinal (GI) conditions i.e., irritable bowel, diverticulitis, peptic ulcers, Crohn's, GI cancers, and adenatomous polyps
- antibiotic or probiotic use in the previous 90 days
- tobacco use
- heavy alcohol consumption
- major medical conditions (e.g., renal disease, diabetes, cancer)
Where it is running
- Moffit Cancer Center — Tampa, Florida, United States
Full record on ClinicalTrials.gov
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