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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

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Moffit Cancer Center
Coordinator of this site? Confirm its status
TampaUnited StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.