Obesity
Conditions
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.
Interventions
BEHAVIORALDASH diet
brief description
BEHAVIORALstandard American diet
describe
Sponsors
H. Lee Moffitt Cancer Center and Research Institute
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean Weight Change of Participants | Baseline to day 28 | Weight change as measured by a scale in kilograms at multiple time points will be calculated and averaged. |
| Diet-specific changes in secondary bile acid | Baseline to day 28 | The investigators will calculate changes in cholic acid in milligrams. |
| Diet-specific changes in inflammatory marker | baseline to day 28 | The investigators will calculate changes in c-reactive protein in mg/L. |
| Diet-specific changes in short chain fatty acids | baseline to day 28 | The investigators will calculate changes in acetic acid in mmol/L |
Countries
United States
Contacts
Primary ContactTiffany L Carson, PhD
Outcome results
None listed