NCT03924778Not yet recruiting
Modifying Diet to Improve Gut Microbiome
Modifying Diet and the Gut Microbiota to Reduce Obesity and Health Disparities
Source: ClinicalTrials.gov · Last updated 17 Sept 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 28 (estimated)
- First submitted
- 25 Mar 2019
- Start date
- Jul 2027
- Primary completion date
- Aug 2027
- Lead sponsor
- H. Lee Moffitt Cancer Center and Research Institute
- Diseases
- Obesity
- NCT number
- NCT03924778
What you commit to
- Study type: Interventional
- Planned participants: 28
- From Jul 2027 to the primary completion date, Aug 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- antibiotic or probiotic use in the previous 90 days
Other illness
- gastrointestinal (GI) conditions i.e., irritable bowel, diverticulitis, peptic ulcers, Crohn's, GI cancers, and adenatomous polyps
- major medical conditions (e.g., renal disease, diabetes, cancer)
Other
- tobacco use
- heavy alcohol consumption
Who the study is looking for
- female
- non-Hispanic, black or white
- age 19-65 years
- BMI \>= 30 kg/m\^2
- able to visit Bionutrition Unit daily
Age in the registry: 18 years to - · Sex: Female · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Moffit Cancer Center Coordinator of this site? Confirm its status | Tampa | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.