Modifying Diet to Improve Gut Microbiome

Sponsor

H. Lee Moffitt Cancer Center and Research Institute (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT03924778

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

2.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Obesity	Behavioral: DASH diet Behavioral: standard American diet	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

28 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Anticipated Study Start Date :

Sep 1, 2022

Anticipated Primary Completion Date :

Sep 1, 2022

Anticipated Study Completion Date :

Sep 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: DASH diet calorie-restricted DASH diet (25% fat; 57% carbohydrate; 18% protein; 34 g fiber	Behavioral: DASH diet brief description
Active Comparator: standard American diet calorie-restricted standard American diet (35% fat; 51% carbohydrate; %15 protein; 14 g fiber	Behavioral: standard American diet describe

Arm

Intervention/Treatment

Experimental: DASH diet

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

Behavioral: DASH diet

brief description

Active Comparator: standard American diet

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

Behavioral: standard American diet

describe

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Moffit Cancer Center	Tampa	Florida	United States	33612

Sponsors and Collaborators

H. Lee Moffitt Cancer Center and Research Institute

Investigators

Principal Investigator: Tiffany L Carson, PhD, Moffitt Cancer Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

H. Lee Moffitt Cancer Center and Research Institute

ClinicalTrials.gov Identifier:

NCT03924778

Other Study ID Numbers:

IRB-300003207

First Posted:

Apr 23, 2019

Last Update Posted:

May 11, 2022

Last Verified:

May 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Obesity

Study Results

No Results Posted as of May 11, 2022