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出境医 / 临床实验 / Modifying Diet to Improve Gut Microbiome

Modifying Diet to Improve Gut Microbiome

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 Not Applicable

Study Design
Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated 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
Estimated Study Start Date : September 2021
Estimated Primary Completion Date : September 2022
Estimated Study Completion Date : September 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
Outcome Measures
Primary Outcome Measures :
  1. Mean Weight Change of Participants [ Time Frame: Baseline to day 28 ]
    Weight change as measured by a scale in kilograms at multiple time points will be calculated and averaged.

  2. Mean Weight Change of Participants [ Time Frame: Day 28 to Day 42 ]
    Weight change as measured by a scale in kilograms at multiple time points will be calculated and averaged.

  3. Mean Weight Change of Participants [ Time Frame: Baseline to day 42 ]
    Weight change as measured by a scale in kilograms at multiple time points will be calculated and averaged.

  4. Diet-specific changes in secondary bile acid [ Time Frame: Baseline to day 28 ]
    The investigators will calculate changes in cholic acid in milligrams.

  5. Diet-specific changes in secondary bile acid [ Time Frame: day 28 to day 42 ]
    The investigators will calculate changes in cholic acid in milligrams.

  6. Diet-specific changes in secondary bile acid [ Time Frame: baseline to day 42 ]
    The investigators will calculate changes in cholic acid in milligrams.

  7. Diet-specific changes in inflammatory marker [ Time Frame: baseline to day 28 ]
    The investigators will calculate changes in c-reactive protein in mg/L.

  8. Diet-specific changes in inflammatory marker [ Time Frame: day 28 to day 42 ]
    The investigators will calculate changes in c-reactive protein in mg/L.

  9. Diet-specific changes in inflammatory marker [ Time Frame: baseline to day 42 ]
    The investigators will calculate changes in c-reactive protein in mg/L.

  10. Diet-specific changes in short chain fatty acids [ Time Frame: baseline to day 28 ]
    The investigators will calculate changes in acetic acid in mmol/L

  11. Diet-specific changes in short chain fatty acids [ Time Frame: day 28 to day 42 ]
    The investigators will calculate changes in acetic acid in mmol/L

  12. Diet-specific changes in short chain fatty acids [ Time Frame: baseline to day 42 ]
    The investigators will calculate changes in acetic acid in mmol/L


Eligibility Criteria
Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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)
Contacts and Locations

Contacts
Layout table for location contacts
Contact: Tiffany L Carson, PhD 813-745-4944 Tiffany.Carson@moffitt.org

Locations
Layout table for location information
United States, Florida
Moffit Cancer Center
Tampa, Florida, United States, 33612
Contact: Tiffany Carson, PhD    813-745-4944    Tiffany.Carson@moffitt.org   
Principal Investigator: Tiffany Carson, PhD         
Sponsors and Collaborators
H. Lee Moffitt Cancer Center and Research Institute
Investigators
Layout table for investigator information
Principal Investigator: Tiffany L Carson, PhD Moffitt Cancer Center
Tracking Information
First Submitted Date  ICMJE March 25, 2019
First Posted Date  ICMJE April 23, 2019
Last Update Posted Date April 19, 2021
Estimated Study Start Date  ICMJE September 2021
Estimated Primary Completion Date September 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 19, 2019)
  • Mean Weight Change of Participants [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: Baseline to day 28 ]
    The investigators will calculate changes in cholic acid in milligrams.
  • Diet-specific changes in secondary bile acid [ Time Frame: day 28 to day 42 ]
    The investigators will calculate changes in cholic acid in milligrams.
  • Diet-specific changes in secondary bile acid [ Time Frame: baseline to day 42 ]
    The investigators will calculate changes in cholic acid in milligrams.
  • Diet-specific changes in inflammatory marker [ Time Frame: baseline to day 28 ]
    The investigators will calculate changes in c-reactive protein in mg/L.
  • Diet-specific changes in inflammatory marker [ Time Frame: day 28 to day 42 ]
    The investigators will calculate changes in c-reactive protein in mg/L.
  • Diet-specific changes in inflammatory marker [ Time Frame: baseline to day 42 ]
    The investigators will calculate changes in c-reactive protein in mg/L.
  • Diet-specific changes in short chain fatty acids [ Time Frame: baseline to day 28 ]
    The investigators will calculate changes in acetic acid in mmol/L
  • Diet-specific changes in short chain fatty acids [ Time Frame: day 28 to day 42 ]
    The investigators will calculate changes in acetic acid in mmol/L
  • Diet-specific changes in short chain fatty acids [ Time Frame: baseline to day 42 ]
    The investigators will calculate changes in acetic acid in mmol/L
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Modifying Diet to Improve Gut Microbiome
Official Title  ICMJE Modifying Diet and the Gut Microbiota to Reduce Obesity and Health Disparities
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Obesity
Intervention  ICMJE
  • Behavioral: DASH diet
    brief description
  • Behavioral: standard American diet
    describe
Study Arms  ICMJE
  • Experimental: DASH diet
    calorie-restricted DASH diet (25% fat; 57% carbohydrate; 18% protein; 34 g fiber
    Intervention: Behavioral: DASH diet
  • Active Comparator: standard American diet
    calorie-restricted standard American diet (35% fat; 51% carbohydrate; %15 protein; 14 g fiber
    Intervention: Behavioral: standard American diet
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: April 19, 2019) 		28
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE September 2023
Estimated Primary Completion Date September 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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)
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Tiffany L Carson, PhD 813-745-4944 Tiffany.Carson@moffitt.org
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03924778
Other Study ID Numbers  ICMJE IRB-300003207
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party H. Lee Moffitt Cancer Center and Research Institute
Study Sponsor  ICMJE H. Lee Moffitt Cancer Center and Research Institute
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Tiffany L Carson, PhD Moffitt Cancer Center
PRS Account H. Lee Moffitt Cancer Center and Research Institute
Verification Date April 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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