Modifying Diet to Improve Gut Microbiome
ConditionObesity
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorH. Lee Moffitt Cancer Center and Research Institute
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
female
non-Hispanic, black or white
age 19-65 years
BMI >= 30 kg/m²
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
DASH diet
Behavioralbrief description
standard American diet
Behavioraldescribe
Treatment groups
28 Participants
are divided into 2 treatment groupsGroup A: DASH dietExperimental treatment 1 intervention
Group B: standard American dietActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Mean Weight Change of Participants
Weight change as measured by a scale in kilograms at multiple time points will be calculated and averaged.
Time frame
Baseline to day 282
Mean Weight Change of Participants
Weight change as measured by a scale in kilograms at multiple time points will be calculated and averaged.
Time frame
Day 28 to Day 423
Mean Weight Change of Participants
Weight change as measured by a scale in kilograms at multiple time points will be calculated and averaged.
Time frame
Baseline to day 424
Diet-specific changes in secondary bile acid
The investigators will calculate changes in cholic acid in milligrams.
Time frame
Baseline to day 28Sponsors and contacts
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Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: