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Purpose

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.

Condition

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
Female
Accepts Healthy Volunteers
Yes

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

Phase
N/A
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

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

More Details

Status
Not yet recruiting
Sponsor
H. Lee Moffitt Cancer Center and Research Institute

Study Contact

Tiffany L Carson, PhD
813-745-4944
Tiffany.Carson@moffitt.org

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.