Records View

Application of human body to confirm body fat improvement effect and safety of plant origin probiotics

Status Approved

  • First Submitted Date

    2020/01/08

  • Registered Date

    2020/01/22

  • Last Updated Date

    2020/01/08

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
    KCT0004641
    Unique Protocol ID 2019-10-007
    Public/Brief Title Application of human body to confirm body fat improvement effect and safety of plant origin probiotics
    Scientific Title Application of human body to confirm body fat improvement effect and safety of plant origin probiotics
    Acronym LPD_DS
    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 DMC-201910007003
    Approval Date 2019-12-23
    Institutional Review Board Name Daejin Medical Foundation Bundang Jaesang Hospital Hospital Bioethics Review Board
    Institutional Review Board Address 20, Seohyeon-ro 180beon-gil, Bundang-gu, Seongnam-si, Gyeonggi-do
    Institutional Review Board Telephone 031-779-5061
    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 Oran Kwon
    Title Professor
    Telephone +82-2-3277-3087
    Affiliation Ewha Womens University
    Address 52, Ewhayeodae-gil, Seodaemun-gu, Seoul
    Contact Person for Public Queries
    Name Kyuyoung Han
    Title Graduate student
    Telephone +82-2-3277-3087
    Affiliation Ewha Womens University
    Address 52, Ewhayeodae-gil, Seodaemun-gu, Seoul
    Contact Person for Updating Information
    Name Kyuyoung Han
    Title Graduate student
    Telephone +82-2-3277-3087
    Affiliation Ewha Womens University
    Address 52, Ewhayeodae-gil, Seodaemun-gu, Seoul
  • 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 Not yet recruiting
    Date of First Enrollment 2020-01-20 Anticipated
    Target Number of Participant 88
    Primary Completion Date 2020-12-22 , Anticipated
    Study Completion Date 2020-12-22 , Anticipated
    Recruitment Status by Participating Study Site 1
    Name of Study Bundang Jesaeng Hospital
    Recruitment Status Not yet recruiting
    Date of First Enrollment 2020-01-20 ,
  • 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 Daesang
    Organization Type Pharmaceutical Company
    Project ID 2-2018-1721-001-1
  • 6. Sponsor Organization

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

    Study Summary Information
    Lay Summary
    The purpose of this study is to evaluating effectiveness and safety of plant origin probiotics on body fat of subjects who are obese aged more than 20 years and less than 65 years old. The study was designed as 12 weeks consumption, randomized, double-blind, parallel, and placebo-control led design.
  • 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
    Phase Not applicable
    Intervention Model Parallel  
    Blinding/Masking Double
    Blinded Subject Subject, Investigator
    Allocation RCT
    Intervention Type Dietary Supplement  
    Intervention Description
    Subject who voluntarily agree to participate and signs informed consent form at visit1(0week) are diagnosed whether they are suitable or not by inclusive and exclusive criteria. Then subjects are randomly assigned to placebo or plant origin probiotics group according to registered order. Control group takes 2 placebo capsules and test group takes 2 plant origin probiotics capsules (500mg/capsule) once for two times a day for 12 weeks and carrying out the efficacy test at each visit.
    Number of Arms 2
    Arm 1

    Arm Label

    Experimental group

    Target Number of Participant

    44

    Arm Type

    Experimental

    Arm Description

    Consumption of 2 capsules of plant origin probiotics twice a day for 12 weeks
    Arm 2

    Arm Label

    Control group (Placebo)

    Target Number of Participant

    44

    Arm Type

    Placebo comparator

    Arm Description

    Consumption of 2 placebo capsules twice a day for 12 weeks
  • 9. Subject Eligibility

    Subject Eligibility Information
    Condition(s)/Problem(s) * (E00-E90)Endocrine, nutritional and metabolic diseases 
       (E66.0)Obesity due to excess calories 

    Obese adults with increased fat mass due to excessive diet
    Rare Disease No
    Inclusion Criteria

    Gender

    Both

    Age

    20Year~63Year

    Description

    1) Subject who voluntarily agree to participate and signs informed consent form
    2) Aged more than 19 years and less less than 65 years, women and men
    3) Those who have a body mass index (BMI) of 25kg/ bb m*2 or more and less than 30kg/m*2
    4) Those who can follow the diet and exercise guidelines during the intervention period
    Exclusion Criteria
    1) Those who have taken or are likely to take medications that affect body weight, blood sugar, lipids, or intestinal health within one month of the first visit
    2) Those who have taken antibiotics within 2 months of the first visit or are likely to take it during the study
    3) If you have,
        1.Uncontrolled hypertension 
       2. Those who have been diagnosed with diabetes or are determined to need treatment, or who have fasting blood sugar 
           level of 180 mg / dL or more
       3. Liver dysfunction or hepatobiliary disease
       4. Renal dysfunction 
       5. Hyperthyroidism and hypofunction, Cushing's syndrome
       6.  If you have a medical history of severe central nervous system disorders that require hospitalization or medication
       7. Those with severe cerebrovascular disease, heart disease. However, dizziness
           If there is no medical history, it may be excluded at the discretion of the researcher.
       8. Malignant tumor, lung disease, musculoskeletal disease, immune system or inflammatory disease
       9. A person who complains of gastrointestinal disorders or severe gastrointestinal symptoms such as heartburn, 
           indigestion or severe constipation
    10) Those who have continuously consumed dietary supplements or herbal medicines affecting their weight, blood sugar, and lipids within one month of their first visit.
    11) Those who have consistently consumed foods,Probiotics
    12) Those who have hypersensitivity to the test / control food or ingredients or have experienced severe food allergic 
          reactions.
    13) Participants in other human application research within 1 month of first visit
    14) Pregnant or lactating women
    15) Those who have difficulty using a smartphone or computer
    16) If the researcher deems inappropriate to participate in this study
    Healthy Volunteers No
  • 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
    Body fat improvement indicator
    Timepoint
    Week 0(visit2), week 12(visit4)
    Secondary Outcome(s) 1
    Outcome
    Body fat related metabolic indicators
    Timepoint
    Week 0(visit2), week 12(visit4)
  • 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
화면 최상단으로 이동

TOP

BOTTOM

화면 최하단으로 이동