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A 12 week, Multi-center, Randomized, Double-Blind, Placebo-Controlled Clinical Trial for the Evaluation of the Efficacy and Safety of MED-02 Probiotics on Reducing Body Fat

Status Approved

  • First Submitted Date

    2020/12/04

  • Registered Date

    2021/02/03

  • Last Updated Date

    2020/12/04

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
    KCT0005861
    Unique Protocol ID PAIK 2020-09-010-002
    Public/Brief Title A Clinical Trial for the Evaluation of the Efficacy and Safety of MED-02 Probiotics on Reducing Body Fat
    Scientific Title A 12 week, Multi-center, Randomized, Double-Blind, Placebo-Controlled Clinical Trial for the Evaluation of the Efficacy and Safety of MED-02 Probiotics on Reducing Body Fat
    Acronym MEDIOGEN_MED-02
    MFDS Regulated Study Yes
    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 PAIK 2020-09-010-002
    Approval Date 2020-11-09
    Institutional Review Board Name INJE UNIVERSITY SEOUL PAIK HOSPITAL IRB
    Institutional Review Board Address 9, Mareunnae-ro, Jung-gu, Seoul
    Institutional Review Board Telephone 02-2270-0945
    Data Monitoring Committee
  • 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 YOUNGGYU CHO
    Title Dr.
    Telephone +82-2-2270-0097
    Affiliation Inje University Seoul Paik Hospital
    Address 9, Mareunnae-ro, Jung-gu, Seoul 04552, Korea
    Contact Person for Public Queries
    Name YOUNGGYU CHO
    Title Dr.
    Telephone +82-2-2270-0097
    Affiliation Inje University Seoul Paik Hospital
    Address 9, Mareunnae-ro, Jung-gu, Seoul 04552, Korea
    Contact Person for Updating Information
    Name YOUNGGYU CHO
    Title Dr.
    Telephone +82-2-2270-0097
    Affiliation Inje University Seoul Paik Hospital
    Address 9, Mareunnae-ro, Jung-gu, Seoul 04552, 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 Multi-center Number of center : 2
    Overall Recruitment Status Recruiting
    Date of First Enrollment 2020-12-01 Actual
    Target Number of Participant 100
    Primary Completion Date 2021-11-03 , Anticipated
    Study Completion Date 2021-11-03 , Anticipated
    Recruitment Status by Participating Study Site 1
    Name of Study Inje University Seoul Paik Hospital
    Recruitment Status Recruiting
    Date of First Enrollment 2020-12-01 ,
    Recruitment Status by Participating Study Site 2
    Name of Study Inje University Ilsan Paik Hospital
    Recruitment Status Not yet recruiting
    Date of First Enrollment 2020-12-31 ,
  • 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 Mediogen
    Organization Type Others
    Project ID MEDIOGEN_MED-02
  • 6. Sponsor Organization

    Sponsor Organization Information - Organization Name, Organization Type
    1. Sponsor Organization
    Organization Name Inje University Seoul Paik Hospital
    Organization Type Medical Institute
  • 7. Study Summary

    Study Summary Information
    Lay Summary
    Lactobacillus fermentum MG4231 and Lactobacillus fermentum MG4244 constituting MED-02 were confirmed to inhibit the differentiation of adipocytes and accumulation of triglycerides through cell experiments. , Lactobacillus fermentum MG4244 complex reduced body weight and body fat, reduced liver triglyceride and fat cell size, reduced factors related to fat differentiation and fat synthesis such as PPARγ, FAS, aP2, LPL, and improved expression of genes related to fat oxidation such as AMPK and ACC It was confirmed to be.
    This clinical trial was designed to evaluate the efficacy and safety of MED-02 probiotics in overweight or obese subjects on body fat reduction compared to placebo.
  • 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
    Treatment
    Phase Phase2/Phase3
    Intervention Model Parallel  
    Blinding/Masking Double
    Blinded Subject Subject, Investigator
    Allocation RCT
    Intervention Type Dietary Supplement  
    Intervention Description
    Intervention group: MED-02 probiotics 500mg capsule once a day
    Placebo group: placebo 500mg capsule once a day
    Number of Arms 2
    Arm 1

    Arm Label

    Intervention group

    Target Number of Participant

    50

    Arm Type

    Experimental

    Arm Description

    Intervention group: MED-02 probiotics 500mg capsule once a day
    Arm 2

    Arm Label

    Placebo group

    Target Number of Participant

    50

    Arm Type

    Placebo comparator

    Arm Description

    Placebo group: placebo 500mg capsule once a 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

    Age: 19-65
    Body mass index: 25~32
    A person who agrees to participate in this human application test and writes a written consent
    Exclusion Criteria
    Those who are currently being treated for severe cardiovascular, immune system, respiratory system, hepatobiliary system, kidney and urinary system, nervous system, musculoskeletal system, psychotic, infectious disease and malignant tumor
    Those who use drugs that affect weight, health functional foods for weight control purposes, herbal medicines, or weight control formulas
    Those who administered antibiotics within 2 weeks
    Those who have consumed probiotics or lactobacillus products continuously within 2 weeks
    Patients with uncontrolled hypertension
    Diabetic patients with fasting blood sugar of 126 mg/dl or more or taking antidiabetic drugs
    Those whose TSH is less than 0.1 uIU/ml or more than 10 uIU/ml
    Those whose Creatinine is more than twice the normal upper limit
    Those whose AST/ALT is more than 3 times the normal upper limit
    Those who have problems in eating food for human application due to severe gastrointestinal disorders
    People with alcohol use disorder and/or CNS disorder
    Those who are judged to be unable to exercise due to musculoskeletal disorders
    Those who have had a weight change of 10% or more within 3 months
    Those who participated in a commercial obesity program within 3 months
    Those who have participated in other interventional clinical trials within one month or plan to participate in other interventional clinical trials
    Pregnant, nursing or planning to become pregnant
    A person who judges that the tester is inappropriate for other reasons
    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
    Body fat mass
    Timepoint
    week 0, week 12
    Primary Outcome(s) 2
    Outcome
    body fat percentage
    Timepoint
    week 0, week 12
    Secondary Outcome(s) 1
    Outcome
    Body weight, Waist circumference, Hip circumference, WHR, BMI, Lean body mass, Visceral fat area, Subcutaneous fat area, total abdominal fat area, VSR
    Timepoint
    week 0, week 12
    Secondary Outcome(s) 2
    Outcome
    Total cholesterol/HDL cholesterol/LDL cholesterol/Triglyceride/hs-CRP/Adiponectin/Leptin
    Timepoint
    week 0, week 12
  • 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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