Modifying Diet to Improve Gut Microbiome

H. Lee Moffitt Cancer Center and Research Institute

Status: Begins enrollment in 4 months

Conditions: Obesity

Treatments: Behavioral: standard American diet; Behavioral: DASH diet

Study type: Interventional

Funder types: Other

Identifiers

NCT03924778

IRB-300003207

Details and patient eligibility

About

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.

Enrollment: 28 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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28 participants in 2 patient groups

DASH diet

Experimental group

Description:

calorie-restricted DASH diet (25% fat; 57% carbohydrate; 18% protein; 34 g fiber

Treatment:

Behavioral: DASH diet

standard American diet

Active Comparator group

Description:

calorie-restricted standard American diet (35% fat; 51% carbohydrate; %15 protein; 14 g fiber

Treatment:

Behavioral: standard American diet