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A 12-week, randomized, double-blind, placebo-controlled human trial to evaluate the efficacy and safety of Chitooligosaccharide(GO2KA1) on decrease of body fat

Status Approved

  • First Submitted Date

    2021/03/16

  • Registered Date

    2021/03/19

  • Last Updated Date

    2021/03/16

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
    KCT0006015
    Unique Protocol ID GO2KA1-BF-IL
    Public/Brief Title A 12-week, randomized, double-blind, placebo-controlled human trial of Chitooligosaccharide(GO2KA1) on decrease of body fat
    Scientific Title A 12-week, randomized, double-blind, placebo-controlled human trial to evaluate the efficacy and safety of Chitooligosaccharide(GO2KA1) on decrease of body fat
    Acronym
    MFDS Regulated Study No
    IND/IDE Protocol No
    Registered at Other Registry No
    Healthcare Benefit Approval Status Not applicable
  • 2. Institutional Review Board / Ethics Committee

    Institutional Review Board Information
    Board Approval Status Submitted approval
    Board Approval Number WKUIOMH-IRB-2019-09
    Approval Date 2019-09-20
    Institutional Review Board Name Wonkwang University Iksan Korean Medicine Hospital Institutional Review Board
    Institutional Review Board Address 895, Muwang-ro, Iksan-si, Jeollabuk-do
    Institutional Review Board Telephone 063-859-2849
    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 Jeonghan Lee
    Title professor
    Telephone +82-63-859-2807
    Affiliation Wonkwang University. Iksan Korean Medicine Hospital
    Address 895, Muwang-ro, Iksan-si, Jeollabuk-do, Republic of Korea
    Contact Person for Public Queries
    Name Jeonghan Lee
    Title professor
    Telephone +82-63-859-2807
    Affiliation Wonkwang University. Iksan Korean Medicine Hospital
    Address 895, Muwang-ro, Iksan-si, Jeollabuk-do, Republic of Korea
    Contact Person for Updating Information
    Name Jeonghan Lee
    Title professor
    Telephone +82-63-859-2807
    Affiliation Wonkwang University. Iksan Korean Medicine Hospital
    Address 895, Muwang-ro, Iksan-si, Jeollabuk-do, Republic of 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 2019-09-30 Actual
    Target Number of Participant 80
    Primary Completion Date 2020-02-12 , Actual
    Study Completion Date 2020-02-28 , Actual
    Recruitment Status by Participating Study Site 1
    Name of Study Wonkwang University. Iksan Korean Medicine Hospital
    Recruitment Status Completed
    Date of First Enrollment 2019-09-30 ,
  • 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 Biostream Technology
    Organization Type Others
    Project ID
  • 6. Sponsor Organization

    Sponsor Organization Information - Organization Name, Organization Type
    1. Sponsor Organization
    Organization Name Wonkwang University. Iksan Korean Medicine Hospital
    Organization Type Medical Institute
  • 7. Study Summary

    Study Summary Information
    Lay Summary
    This study is a 12 weeks, randomized, double-blind, placebo-controlled human trial to evaluate the efficacy and safety of Chitooligosaccharide(GO2KA1) on decrease of body fat. For decrease of body fat, prescribed Chitooligosaccharide(GO2KA1) for 12 weeks. The measures of this study are to evaluate the efficacy and safety of Chitooligosaccharide(GO2KA1) on improvement of decrease of body fat.
  • 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
    Prevention
    Phase Not applicable
    Intervention Model Parallel  
    Blinding/Masking Double
    Blinded Subject Subject, Investigator
    Allocation RCT
    Intervention Type Dietary Supplement  
    Intervention Description
    • Chitooligosaccharide(GO2KA1) group: twice a day, 2 capsules once, after breakfast and dinner, for 12 weeks{1,600 mg/day, 1,200 mg/day for Chitooligosaccharide(GO2KA1)}
    • Placebo group: twice a day, 2 capsules once, after breakfast and dinner, for 12 weeks(1,600 mg/day)
    Number of Arms 2
    Arm 1

    Arm Label

    Chitooligosaccharide(GO2KA1) group

    Target Number of Participant

    40

    Arm Type

    Experimental

    Arm Description

    • Chitooligosaccharide(GO2KA1) group: twice a day, 2 capsules once, after breakfast and dinner, for 12 weeks{1,600 mg/day, 1,200 mg/day for Chitooligosaccharide(GO2KA1)}
    Arm 2

    Arm Label

    Placebo group

    Target Number of Participant

    40

    Arm Type

    Placebo comparator

    Arm Description

    • Placebo group: twice a day, 2 capsules once, after breakfast and dinner, for 12 weeks(1,600 mg/day)
  • 9. Subject Eligibility

    Subject Eligibility Information
    Condition(s)/Problem(s) * (E00-E90)Endocrine, nutritional and metabolic diseases 
       (E66.9)Obesity, unspecified 

    overweight or obesity
    Rare Disease No
    Inclusion Criteria

    Gender

    Both

    Age

    19Year~65Year

    Description

    1) 25 ≤ BMI ≤ 34.9 kg/m2 or  25%(male), 30%(female) ≤body fat percentage
    2) Participants who have fully understood information provided about the study, voluntarily decided to participate, and agreed to comply with precautions
    Exclusion Criteria
    1) Participants who have had a weight change of 10% of more within the 3 months prior to the screening examination.
    2) Participants with a clinically significant disease requiring treatment (i.e., acute or chronic cardiovascular system, endocrine system, immune system, respiratory system, kidney and urinary system, neuropsychiatric system, musculoskeletal inflammation, inflammatory disease, blood and tumor disease, gastrointestinal disease, etc.)
    3) Fasteners
    4) Participants with a history of antipsychotic medication use within 3 months prior to the screening examination.
    5) Participants who have participated in other interventional clinical trials within 3 months prior to the screening examination, or plan to participate in other interventional clinical trials.
    6) Participants who are judged ineligible to participate in the trial by the principal investigator for other reasons, including laboratory test outcomes.
    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 /Safety/Efficacy
    Primary Outcome(s) 1
    Outcome
    Fat mass by DEXA(Dual-energy X-ray absorptiometry)
    Timepoint
    0, 12 weeks
    Primary Outcome(s) 2
    Outcome
    Percent Body Fat by DEXA(Dual-energy X-ray absorptiometry)
    Timepoint
    0, 12 weeks
    Secondary Outcome(s) 1
    Outcome
    weight
    Timepoint
    screening, 0, 6, 12 weeks
    Secondary Outcome(s) 2
    Outcome
    Body Mass Index(BMI)
    Timepoint
    screening, 0, 6, 12 weeks
  • 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 No
  • 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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