Modifying Diet to Improve Gut Microbiome
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: DASH diet, standard American diet.
- Who it may be relevant to
- Registry conditions: Obesity. Basic parameters: from 18 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Modifying Diet and the Gut Microbiota to Reduce Obesity and Health Disparities
Overview
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
- Behavioral DASH diet
brief description - Behavioral standard American diet
describe
Primary outcome measures
- Mean Weight Change of Participants [Time frame: Baseline to day 28]
- Mean Weight Change of Participants [Time frame: Day 28 to Day 42]
- Mean Weight Change of Participants [Time frame: Baseline to day 42]
- Diet-specific changes in secondary bile acid [Time frame: Baseline to day 28]
- Diet-specific changes in secondary bile acid [Time frame: day 28 to day 42]
- Diet-specific changes in secondary bile acid [Time frame: baseline to day 42]
- Diet-specific changes in inflammatory marker [Time frame: baseline to day 28]
- Diet-specific changes in inflammatory marker [Time frame: day 28 to day 42]
- Diet-specific changes in inflammatory marker [Time frame: baseline to day 42]
- Diet-specific changes in short chain fatty acids [Time frame: baseline to day 28]
Eligibility criteria
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)
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 1 center
- Moffit Cancer Center — Tampa
Identifiers
NCT: NCT03924778 · IRB-300003207