NCT03924778

Modifying Diet to Improve Gut Microbiome

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

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 28 (estimated)
• Sponsor: H. Lee Moffitt Cancer Center and Research Institute · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Conditions

• Obesity

Interventions

Type	Name	Description
BEHAVIORAL	DASH diet	brief description
BEHAVIORAL	standard American diet	describe

Timeline

• Start date: 2026-07-01
• Primary completion: 2026-08-01
• Completion: 2026-08-01
• First posted: 2019-04-23
• Last updated: 2025-09-10

Locations

1 site across 1 country: United States