Modifying Diet to Improve Gut Microbiome

Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03924778
• Other study ID #: IRB-300003207
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 2024
• Est. completion date: June 2025

Study information

• Verified date: June 2023
• Source: H. Lee Moffitt Cancer Center and Research Institute
• Contact: Tiffany L Carson, PhD
• Phone: 813-745-4944
• Email: Tiffany.Carson[@]moffitt.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 28
• Est. completion date: June 2025
• Est. primary completion date: June 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Obesity

Intervention

Behavioral:
• DASH diet
brief description
• standard American diet
describe

Locations

Country	Name	City	State
United States	Moffit Cancer Center	Tampa	Florida

Sponsors (1)

Lead Sponsor	Collaborator
H. Lee Moffitt Cancer Center and Research Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean Weight Change of Participants	Weight change as measured by a scale in kilograms at multiple time points will be calculated and averaged.	Baseline to day 28
Primary	Mean Weight Change of Participants	Weight change as measured by a scale in kilograms at multiple time points will be calculated and averaged.	Day 28 to Day 42
Primary	Mean Weight Change of Participants	Weight change as measured by a scale in kilograms at multiple time points will be calculated and averaged.	Baseline to day 42
Primary	Diet-specific changes in secondary bile acid	The investigators will calculate changes in cholic acid in milligrams.	Baseline to day 28
Primary	Diet-specific changes in secondary bile acid	The investigators will calculate changes in cholic acid in milligrams.	day 28 to day 42
Primary	Diet-specific changes in secondary bile acid	The investigators will calculate changes in cholic acid in milligrams.	baseline to day 42
Primary	Diet-specific changes in inflammatory marker	The investigators will calculate changes in c-reactive protein in mg/L.	baseline to day 28
Primary	Diet-specific changes in inflammatory marker	The investigators will calculate changes in c-reactive protein in mg/L.	day 28 to day 42
Primary	Diet-specific changes in inflammatory marker	The investigators will calculate changes in c-reactive protein in mg/L.	baseline to day 42
Primary	Diet-specific changes in short chain fatty acids	The investigators will calculate changes in acetic acid in mmol/L	baseline to day 28
Primary	Diet-specific changes in short chain fatty acids	The investigators will calculate changes in acetic acid in mmol/L	day 28 to day 42
Primary	Diet-specific changes in short chain fatty acids	The investigators will calculate changes in acetic acid in mmol/L	baseline to day 42