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Modifying Diet to Improve Gut Microbiome

Primary Purpose

Obesity

Status
Not yet recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
DASH diet
standard American diet
Sponsored by
H. Lee Moffitt Cancer Center and Research Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obesity

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleAccepts Healthy Volunteers

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)

Sites / Locations

  • Moffit Cancer Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

DASH diet

standard American diet

Arm Description

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
March 25, 2019
Last Updated
June 20, 2023
Sponsor
H. Lee Moffitt Cancer Center and Research Institute
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1. Study Identification

Unique Protocol Identification Number
NCT03924778
Brief Title
Modifying Diet to Improve Gut Microbiome
Official Title
Modifying Diet and the Gut Microbiota to Reduce Obesity and Health Disparities
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
June 2024 (Anticipated)
Primary Completion Date
June 2025 (Anticipated)
Study Completion Date
June 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
H. Lee Moffitt Cancer Center and Research Institute

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
28 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
DASH diet
Arm Type
Experimental
Arm Description
calorie-restricted DASH diet (25% fat; 57% carbohydrate; 18% protein; 34 g fiber
Arm Title
standard American diet
Arm Type
Active Comparator
Arm Description
calorie-restricted standard American diet (35% fat; 51% carbohydrate; %15 protein; 14 g fiber
Intervention Type
Behavioral
Intervention Name(s)
DASH diet
Intervention Description
brief description
Intervention Type
Behavioral
Intervention Name(s)
standard American diet
Intervention Description
describe
Primary Outcome Measure Information:
Title
Mean Weight Change of Participants
Description
Weight change as measured by a scale in kilograms at multiple time points will be calculated and averaged.
Time Frame
Baseline to day 28
Title
Mean Weight Change of Participants
Description
Weight change as measured by a scale in kilograms at multiple time points will be calculated and averaged.
Time Frame
Day 28 to Day 42
Title
Mean Weight Change of Participants
Description
Weight change as measured by a scale in kilograms at multiple time points will be calculated and averaged.
Time Frame
Baseline to day 42
Title
Diet-specific changes in secondary bile acid
Description
The investigators will calculate changes in cholic acid in milligrams.
Time Frame
Baseline to day 28
Title
Diet-specific changes in secondary bile acid
Description
The investigators will calculate changes in cholic acid in milligrams.
Time Frame
day 28 to day 42
Title
Diet-specific changes in secondary bile acid
Description
The investigators will calculate changes in cholic acid in milligrams.
Time Frame
baseline to day 42
Title
Diet-specific changes in inflammatory marker
Description
The investigators will calculate changes in c-reactive protein in mg/L.
Time Frame
baseline to day 28
Title
Diet-specific changes in inflammatory marker
Description
The investigators will calculate changes in c-reactive protein in mg/L.
Time Frame
day 28 to day 42
Title
Diet-specific changes in inflammatory marker
Description
The investigators will calculate changes in c-reactive protein in mg/L.
Time Frame
baseline to day 42
Title
Diet-specific changes in short chain fatty acids
Description
The investigators will calculate changes in acetic acid in mmol/L
Time Frame
baseline to day 28
Title
Diet-specific changes in short chain fatty acids
Description
The investigators will calculate changes in acetic acid in mmol/L
Time Frame
day 28 to day 42
Title
Diet-specific changes in short chain fatty acids
Description
The investigators will calculate changes in acetic acid in mmol/L
Time Frame
baseline to day 42

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Tiffany L Carson, PhD
Phone
813-745-4944
Email
Tiffany.Carson@moffitt.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tiffany L Carson, PhD
Organizational Affiliation
Moffitt Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Moffit Cancer Center
City
Tampa
State/Province
Florida
ZIP/Postal Code
33612
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tiffany Carson, PhD
Phone
813-745-4944
Email
Tiffany.Carson@moffitt.org
First Name & Middle Initial & Last Name & Degree
Tiffany Carson, PhD

12. IPD Sharing Statement

Plan to Share IPD
No

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Modifying Diet to Improve Gut Microbiome

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