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Effects of Intermittent Fasting on Mitochondrial Function and Oxidative Stress: A Crossover Study

Status Approved

  • First Submitted Date

    2017/04/10

  • Registered Date

    2017/04/19

  • Last Updated Date

    2017/04/13

CRIS Required

WHO ICTRP (International Clinical Trial Registry Platform) Required

  • 1. Background

    Background - CRIS Registration Number, Unique Protocol ID, Public/Brief Title, Scientific Title, Acronym, MFDS Regulated Study, IND/IDE Protocol, Registered at Other Registry, Name of Registry/Registration Number
    CRIS
    Registration Number
    KCT0002313
    Unique Protocol ID YWMR-15-9-081
    Public/Brief Title Effects of Intermittent Fasting on Mitochondrial Function and Oxidative Stress: A Crossover Study
    Scientific Title Effects of Intermittent Fasting on Mitochondrial Function and Oxidative Stress: A Crossover Study
    Acronym
    MFDS Regulated Study No
    IND/IDE Protocol No
    Registered at Other Registry No
    Healthcare Benefit Approval Status
  • 2. Institutional Review Board / Ethics Committee

    Institutional Review Board Information
    Board Approval Status Submitted approval
    Board Approval Number YWMR-15-9-081
    Approval Date 2015-11-11
    Institutional Review Board Name The Research Ethics Committee of Yonsei University Wonju College of Medicine
    Institutional Review Board Address
    Institutional Review Board Telephone
    Data Monitoring Committee No
  • 3. Contact Details

    Contact Details Information - Contact Person for Principal Investigator / Scientific Queries, Contact Person for Public Queries, Contact Person for Updating Information의 Name, Title, Email, Telephone, Cellular Phone, Affiliation, Address
    Contact Person for Principal Investigator / Scientific Queries
    Name Song Vogue Ahn
    Title Associate Professor
    Telephone +82-33-741-0348
    Affiliation Yonsei University
    Address Department of Preventive Medicine, Yonsei University Wonju College of Medicine, 20 Ilsan-ro, Wonju, Gangwon-do 26426, South Korea
    Contact Person for Public Queries
    Name Song Vogue Ahn
    Title Associate Professor
    Telephone +82-33-741-0348
    Affiliation Yonsei University
    Address Department of Preventive Medicine, Yonsei University Wonju College of Medicine, 20 Ilsan-ro, Wonju, Gangwon-do 26426, South Korea
    Contact Person for Updating Information
    Name Song Vogue Ahn
    Title Associate Professor
    Telephone +82-33-741-0348
    Affiliation Yonsei University
    Address Department of Preventive Medicine, Yonsei University Wonju College of Medicine, 20 Ilsan-ro, Wonju, Gangwon-do 26426, South Korea
  • 4. Status

    Status Information - Study Site, Overall Recruitment Status, Date of First Enrollment, Status of First Enrollment, Target Number of Participant, Primary Completion Date, Recruitment Status by Participating Study Site, Name of Study Site, Recruitment Status, Date of First Enrollment, Status of First Enrollemnt
    Study Site Single
    Overall Recruitment Status Completed
    Date of First Enrollment 2015-11-13 Actual
    Target Number of Participant 36
    Primary Completion Date 2016-05-13 , Actual
    Study Completion Date 2017-02-24 , Actual
    Recruitment Status by Participating Study Site 1
    Name of Study Yonsei University
    Recruitment Status Completed
    Date of First Enrollment 2015-11-13 ,
  • 5. Source of Monetary / Material Support

    Source of Monetary / Material Support Information - Organization Name, Organization Type, Project ID
    1. Source of Monetary/Material Support
    Organization Name National Research Foundation
    Organization Type Government
    Project ID NRF-2014R1A1A2059462
  • 6. Sponsor Organization

    Sponsor Organization Information - Organization Name, Organization Type
    1. Sponsor Organization
    Organization Name Yonsei University
    Organization Type University
  • 7. Study Summary

    Study Summary Information
    Lay Summary
    This study aims to investigate the effects of intermittent fasting on health indicators in healthy adults. In this study, health indicators include mitochondrial function, oxidative stress, gut microbiome, and cardiovascular risk factors. 
  • 8. Study Design

    Study Design Information - Study Type, Study Purpose, Phase, Intervention Model, Blinding/Masking, Blinded Subject, Allocation, Intervention Type, Intervention Description, Number of Arms, Arm Label, Target Number of Participant, Arm Type, Arm Description
    Study Type Interventional Study
    Study Purpose
    Basic Science
    Phase Not applicable
    Intervention Model Cross-over  
    Blinding/Masking Open
    Allocation RCT
    Intervention Type Behavioral  
    Intervention Description
    1. Intervention period: Intermittent fasting for 8 weeks (fasting for 24 hours once a week)
    - Subjects do not eat any food except water during fasting.
    - During non-fasting, subjects are allowed to freely eat meals and snacks as usual, but do not intentionally reduce or increase the frequency or amount of meals.
    
    2. Control period: Non-fasting diet for 8 weeks
    - Subjects are allowed to freely eat meals and snacks as usual, but do not intentionally reduce or increase the frequency or amount of meals.
    
    3. 8-week washout period is included between the intervention period and the control period.
    Number of Arms 2
    Arm 1

    Arm Label

    Intervention-Control group

    Target Number of Participant

    18

    Arm Type

    Others

    Arm Description

    1. First, an intervention period of 8 weeks (fasting for 24 hours once a week)
    2. Second, a washout period of 8 weeks
    3. Third, a control period of 8 weeks (Non-fasting diet for 8 weeks)
    Arm 2

    Arm Label

    Control-Intervention group

    Target Number of Participant

    18

    Arm Type

    Others

    Arm Description

    1. First, a control period of 8 weeks (Non-fasting diet for 8 weeks)
    2. Second, a washout period of 8 weeks
    3. Third, an intervention period of 8 weeks (fasting for 24 hours once a week)
  • 9. Subject Eligibility

    Subject Eligibility Information
    Condition(s)/Problem(s) * (E00-E90)Endocrine, nutritional and metabolic diseases 
       (E66.9)Obesity, unspecified 
    Rare Disease No
    Inclusion Criteria

    Gender

    Female

    Age

    25Year~45Year

    Description

    1. Healthy women
    2. Volunteers
    3. Body mass index ≥ 23
    4. Usual eating pattern of 2 or 3 meals/day during the past 1 year
    Exclusion Criteria
    1. Smokers
    2. History of diabetes
    3. History of CVD
    4. Regular use of medications
    5. History of major psychiatric disorders
    6. History of eating disorders
    7. Individuals who have attempted intentional weight control or dietary restriction during the past 1 year
    8. Individuals with alcoholism or other substance abuse
    9. Pregnancy or lactation
    10. High-risk occupations requiring full alertness and motor skills (airplane pilots, etc)
    Healthy Volunteers Yes
  • 10. Outcome Measure(s)

    Outcome Measure(s) Information - Type of Primary Outcome, Primary Outcome, Outcome, Timepoint, Secondary Outcome, Outcome, Timepoint
    Type of Primary Outcome Efficacy
    Primary Outcome(s) 1
    Outcome
    Changes in mitochondrial DNA copy number
    Timepoint
    Baseline, Week 8
    Secondary Outcome(s) 1
    Outcome
    Changes in oxidized LDL
    Timepoint
    Baseline, Week 8
    Secondary Outcome(s) 2
    Outcome
    Changes in gut microbiome
    Timepoint
    Baseline, Week 8
    Secondary Outcome(s) 3
    Outcome
    Changes in FGF-21
    Timepoint
    Baseline, Week 8
    Secondary Outcome(s) 4
    Outcome
    Changes in cytokines
    Timepoint
    Baseline, Week 8
    Secondary Outcome(s) 5
    Outcome
    Changes in adipokines
    Timepoint
    Baseline, Week 8
  • 11. Study Results and Publication

    Study Results and Publication Information - Result Registered, Final Enrollment Number, Number of Publication, Publications, Results Upload, Date of Posting Results, Protocol URL or File Upload, Brief Summary
    Result Registered
  • 12. Sharing of Study Data(Deidentified Individual-Patient Data, IPD)

    Sharing of Study Data Information - Sharing Statement, Time of Sharing, Way of Sharing
    Sharing Statement No
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