Modifying Diet to Improve Gut Microbiome

Not Applicable

Not yet recruiting

• Conditions: Obesity

• Registration Number: NCT03924778
• Lead Sponsor: H. Lee Moffitt Cancer Center and Research Institute

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-03-25
• Study First Submitted QC: 2019-04-19
• Study First Posted: 2019-04-23
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-04
• Last Update Posted: 2025-03-05
• Study Start: 2025-07
• Primary Completion: 2026-06
• Study Completion: 2026-06

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Female
• Target Recruitment: 28

Inclusion Criteria

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

Exclusion Criteria

• 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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Diet-specific changes in secondary bile acid	baseline to day 42	The investigators will calculate changes in cholic acid in milligrams.
Mean Weight Change of Participants	Baseline to day 42	Weight change as measured by a scale in kilograms at multiple time points will be calculated and averaged.
Diet-specific changes in inflammatory marker	baseline to day 42	The investigators will calculate changes in c-reactive protein in mg/L.
Diet-specific changes in short chain fatty acids	baseline to day 42	The investigators will calculate changes in acetic acid in mmol/L

Trial Locations

Locations (1)

Moffit Cancer Center; 🇺🇸 Tampa, Florida, United States