Clinical trial NCT03924778: Modifying Diet to Improve Gut Microbiome
Official title: Modifying Diet and the Gut Microbiota to Reduce Obesity and Health Disparities
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Obesity
Lead sponsor: H. Lee Moffitt Cancer Center and Research Institute
Sponsor class: OTHER
First posted: 2019-04-23
Enrollment: 28
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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)

Primary outcomes:
measure: Mean Weight Change of Participants
timeFrame: Baseline to day 28
measure: Mean Weight Change of Participants
timeFrame: Day 28 to Day 42
measure: Mean Weight Change of Participants
timeFrame: Baseline to day 42
measure: Diet-specific changes in secondary bile acid
timeFrame: Baseline to day 28
measure: Diet-specific changes in secondary bile acid
timeFrame: day 28 to day 42
measure: Diet-specific changes in secondary bile acid
timeFrame: baseline to day 42
measure: Diet-specific changes in inflammatory marker
timeFrame: baseline to day 28
measure: Diet-specific changes in inflammatory marker
timeFrame: day 28 to day 42
measure: Diet-specific changes in inflammatory marker
timeFrame: baseline to day 42
measure: Diet-specific changes in short chain fatty acids
timeFrame: baseline to day 28
measure: Diet-specific changes in short chain fatty acids
timeFrame: day 28 to day 42
measure: Diet-specific changes in short chain fatty acids
timeFrame: baseline to day 42
Secondary outcomes:
Other outcomes:
Locations:
city: Tampa
country: United States
facility: Moffit Cancer Center
state: Florida
Study officials:
affiliation: Moffitt Cancer Center
name: Tiffany L Carson, PhD
role: PRINCIPAL_INVESTIGATOR
References: