Modifying Diet and the Gut Microbiota to Reduce Obesity and Health Disparities

Modifying Diet to Improve Gut Microbiome

Sponsors

Lead sponsor: University of Alabama at Birmingham

Source University of Alabama at Birmingham
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.

Overall Status Recruiting
Start Date August 5, 2019
Completion Date April 2020
Primary Completion Date April 2020
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
Mean Weight Change of Participants Baseline to day 28
Mean Weight Change of Participants Day 28 to Day 42
Mean Weight Change of Participants Baseline to day 42
Diet-specific changes in secondary bile acid Baseline to day 28
Diet-specific changes in secondary bile acid day 28 to day 42
Diet-specific changes in secondary bile acid baseline to day 42
Diet-specific changes in inflammatory marker baseline to day 28
Diet-specific changes in inflammatory marker day 28 to day 42
Diet-specific changes in inflammatory marker baseline to day 42
Diet-specific changes in short chain fatty acids baseline to day 28
Diet-specific changes in short chain fatty acids day 28 to day 42
Diet-specific changes in short chain fatty acids baseline to day 42
Enrollment 28
Condition
Intervention

Intervention type: Behavioral

Intervention name: DASH diet

Description: brief description

Arm group label: DASH diet

Intervention type: Behavioral

Intervention name: standard American diet

Description: describe

Arm group label: standard American diet

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)

Gender: Female

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: Accepts Healthy Volunteers

Overall Official
Last Name Role Affiliation
Tiffany L Carson, PhD Principal Investigator University of Alabama at Birmingham
Overall Contact

Last name: Tiffany L Carson, PhD

Phone: 205-934-1443

Email: [email protected]

Location
facility status contact investigator University of Alabama at Birmingham Tiffany Carson, PhD Tiffany Carson, PhD Principal Investigator
Location Countries

United States

Verification Date

October 2019

Responsible Party

Responsible party type: Principal Investigator

Investigator affiliation: University of Alabama at Birmingham

Investigator full name: Tiffany Carson

Investigator title: Assistant Professor

Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Arm group label: DASH diet

Arm group type: Experimental

Description: calorie-restricted DASH diet (25% fat; 57% carbohydrate; 18% protein; 34 g fiber

Arm group label: standard American diet

Arm group type: Active Comparator

Description: calorie-restricted standard American diet (35% fat; 51% carbohydrate; %15 protein; 14 g fiber

Patient Data No
Study Design Info

Allocation: Randomized

Intervention model: Parallel Assignment

Primary purpose: Treatment

Masking: None (Open Label)

Source: ClinicalTrials.gov