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NOT YET RECRUITING
NCT03924778
NA

Modifying Diet to Improve Gut Microbiome

Sponsor: H. Lee Moffitt Cancer Center and Research Institute

View on ClinicalTrials.gov

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.

Official title: Modifying Diet and the Gut Microbiota to Reduce Obesity and Health Disparities

Key Details

Gender

FEMALE

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

28

Start Date

2026-07

Completion Date

2026-08

Last Updated

2025-09-10

Healthy Volunteers

Yes

Conditions

Interventions

BEHAVIORAL

DASH diet

brief description

BEHAVIORAL

standard American diet

describe

Locations (1)

Moffit Cancer Center

Tampa, Florida, United States