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A 12-week, randomized, double-blind, placebo-controlled human trial to evaluate the efficacy and safety of TZ-HVP on decrement of body fat

Status Approved

  • First Submitted Date

    2021/02/03

  • Registered Date

    2021/02/10

  • Last Updated Date

    2021/03/17

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
    KCT0005883
    Unique Protocol ID WSOH IRB H2012-01-01
    Public/Brief Title Human trial study to evaluate the efficacy and safety of TZ-HVP on decrement of body fat
    Scientific Title A 12-week, randomized, double-blind, placebo-controlled human trial to evaluate the efficacy and safety of TZ-HVP on decrement 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 WSOH IRB H2012-01-01
    Approval Date 2020-12-24
    Institutional Review Board Name Woosuk University Korean Medicine Medical Center Institutional Review Board
    Institutional Review Board Address 46, Eoeun-ro, Wansan-gu, Jeonju-si, Jeollabuk-do
    Institutional Review Board Telephone 063-220-8750
    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 lee Eun hee
    Title associate professor
    Telephone +82-63-220-8606
    Affiliation Woosuk University
    Address 443, samrye-ro, wanju-gun, Jeollabuk-do
    Contact Person for Public Queries
    Name Gwak` ji young
    Title Researcher
    Telephone +82-63-277-8930
    Affiliation BioFoods Story
    Address 16, Angol 4-gil, Deokjin-gu, Jeonju-si, Jeollabuk-do
    Contact Person for Updating Information
    Name Gwak` ji young
    Title Researcher
    Telephone +82-63-277-8930
    Affiliation BioFoods Story
    Address 16, Angol 4-gil, Deokjin-gu, Jeonju-si, Jeollabuk-do
  • 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 Recruiting
    Date of First Enrollment 2021-02-22 Actual
    Target Number of Participant 100
    Primary Completion Date
    Study Completion Date 2021-09-30 , Anticipated
    Recruitment Status by Participating Study Site 1
    Name of Study Woosuk University Korean Medicine Medical Center
    Recruitment Status Recruiting
    Date of First Enrollment 2021-02-22 ,
  • 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 Teazen
    Organization Type Others
    Project ID
  • 6. Sponsor Organization

    Sponsor Organization Information - Organization Name, Organization Type
    1. Sponsor Organization
    Organization Name Teazen
    Organization Type Others
  • 7. Study Summary

    Study Summary Information
    Lay Summary
    The purpose of this study was to evaluate the efficacy and safety of TZ-HVP-related body fat indexes by observing changes in body fat indexes in subjects who were overweight or obese.
    The participants in this study voluntarily visit the institution and sign up for their participation. As they go through pre-examination, if the participants meet inclusion criteria, their enrollment will be decided. Then, selected participants will be randomly placed to either test or placebo group; the members in these group will intake test or placebo supplement for 12 weeks
  • 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
    Others
    (funtional food)
    Phase Not applicable
    Intervention Model Parallel  
    Blinding/Masking Double
    Blinded Subject Subject, Investigator
    Allocation RCT
    Intervention Type Dietary Supplement  
    Intervention Description
    - experimental group 50 people / placebo group 50 people 
    - intake 2 tablet / time and 1 times a day 
    - intake for 12 weeks
    Number of Arms 2
    Arm 1

    Arm Label

    Experimental

    Target Number of Participant

    50

    Arm Type

    Experimental

    Arm Description

    - Hordeum vulgare L. Extract 1g/day 
    - intake 2 tablet / time and 1 times a day 
    - intake for 12 weeks
    Arm 2

    Arm Label

    Placebo group

    Target Number of Participant

    50

    Arm Type

    Placebo comparator

    Arm Description

    - Placebo
    - intake 2 tablet / time and 1 times a day 
    - intake for 12 weeks
  • 9. Subject Eligibility

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

    Overweighted or obesity
    Rare Disease No
    Inclusion Criteria

    Gender

    Both

    Age

    19Year~70Year

    Description

    1) Male or female subjects aged from 19 to 70 years old
    2) BMI of 25 to <30 kg/m2 
    3) Satisfied with 1), 2) and subjects who decided to voluntarily participate in this clinical trial and complete to sign on the informed consent
    Exclusion Criteria
    1) Participants with intentional weight loss of at least 10% within 3 months prior to screening 
    2) Subjects who have experience in influencing the interpretation of the results of this study, such as carbohydrates and lipid metabolism, drugs that can affect weight and hormones, or health functional foods within the last two months. 
    3) Subjects with acute severe cardiovascular disease such as heart failure, myocardial infarction, stroke, etc.
    4) Subjects who in which the local or the systemic inflammatory immune disease including the rheumatoid arthritis, the autoimmune disease etc.
    5) Subjects who have clinically significant hypersensitivity history due to drug, experimental product or ingredients
    6) Subjects who have a medical history of gastrointestinal diseases(Crohn's disease, etc.) or operation(except appendectomy or herniotomy)
    7) Participation in other clinical trials within the previous three months 
    8) Subjects with kidney disease, such as acute/chronic renal failure, nephrotic syndrome, etc
    9) Subjects who has received antipsychotic treatment within two months before screening test 
    10) Subjects with reduced liver or kidney function
    ☞ AST, ALT > 3 times the upper limit of normal
    ☞ Creatinine ≥ 2.0mg/dL
    11) Subjects who are suspected drug abuse or have a medical history of dependent on drug 
    12) Subjects who are pregnant and breastfeeding female
    13) Subject who do not perform adequate contraception in the urban eligible women (except woman who undergo sterilization operation) 
    14) Subject with hypersensitivity to the ingredients contained in a clinical product 
    15) Subject who takes diabetes and diabetes drugs
    16) Uncontrolled hypertension (blood pressure ≥ 160/100 mmHg) 
    17) Subject who deemed inappropriate to participate this clinical trial by research director due to other reasons including screening test
    Healthy Volunteers
  • 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, Percent Body Fat, Lean Mass by DEXA(Dual-energy X-ray absorptiometry)      Dual Energy X-ray Absorptiometry
    Timepoint
    week 0,  week 12
    Secondary Outcome(s) 1
    Outcome
    Body weight
    Timepoint
    screening, week 6,  week 12
    Secondary Outcome(s) 2
    Outcome
    Body mass index
    Timepoint
    screening, week 6,  week 12
    Secondary Outcome(s) 3
    Outcome
    waist circumference, hip circumference, waist circumference/hip circumference ratio
    Timepoint
    screening, week 6,  week 12
    Secondary Outcome(s) 4
    Outcome
    Adipokine(leptin, adiponectin)
    Timepoint
    screening, week 6,  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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