Modifying Diet to Improve Gut Microbiome

Part of paid clinical trials in Tampa, Florida.

Sponsor
H. Lee Moffitt Cancer Center and Research Institute
Study ID
NCT03924778
Status
Not Yet Recruiting

Notify me when recruiting opens

Save your spot on the interest list for this study. We'll keep your details with this study so our team can follow up when recruiting opens.

Not yet recruiting

Add your contact details and location so we can keep your interest tied to this study.

Conditions

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • DASH diet — BEHAVIORAL
    brief description
  • standard American diet — BEHAVIORAL
    describe

Study Details

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 Dates

Start date
Jul 31, 2026
Status verified
Sep 2025
Primary completion
Aug 31, 2026
Completion
Aug 31, 2026

Study Design

Enrollment
28 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: DASH diet
    calorie-restricted DASH diet (25% fat; 57% carbohydrate; 18% protein; 34 g fiber
  • Active Comparator: standard American diet
    calorie-restricted standard American diet (35% fat; 51% carbohydrate; %15 protein; 14 g fiber

Primary Outcome Measure

Mean Weight Change of Participants [ Time Frame: Baseline to day 28 ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Moffit Cancer CenterTampaFlorida33612
Tiffany Carson, PhD
[email protected]
813-745-4944
Tiffany Carson, PhD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Tampa, FL

By condition
Obesity / overweight
By specialty
EndocrinologyMetabolic healthWeight loss
By research site
Moffit Cancer Center· Tampa, FL

Related Studies