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Clinical trial of black rice to evaluate efficacy on bone health and obesity

Status Approved

  • First Submitted Date

    2021/01/21

  • Registered Date

    2021/01/28

  • Last Updated Date

    2021/01/21

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
    KCT0005836
    Unique Protocol ID EU 14-07
    Public/Brief Title Clinical trial of black rice to evaluate efficacy on bone health and obesity
    Scientific Title Clinical trial of black rice to evaluate efficacy on bone health and obesity
    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 EU 14-07
    Approval Date 2014-09-22
    Institutional Review Board Name Institutional Review Board of Eulji University
    Institutional Review Board Address 77, Gyeryong-ro 771beon-gil, Jung-gu, Daejeon
    Institutional Review Board Telephone 042-259-1691
    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 Hae-Jeung Lee
    Title Professor
    Telephone +82-31-750-4720
    Affiliation Gachon University
    Address 1342, Seongnam-daero, Sujeong-gu, Seongnam-si, Gyeonggi-do, Republic of Korea
    Contact Person for Public Queries
    Name Ah Jin Jung
    Title Researcher
    Telephone +82-31-750-4720
    Affiliation Gachon University
    Address 1342, Seongnam-daero, Sujeong-gu, Seongnam-si, Gyeonggi-do, Republic of Korea
    Contact Person for Updating Information
    Name Ah Jin Jung
    Title Researcher
    Telephone +82-31-750-4720
    Affiliation Gachon University
    Address 1342, Seongnam-daero, Sujeong-gu, Seongnam-si, Gyeonggi-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 2014-11-11 Actual
    Target Number of Participant 84
    Primary Completion Date
    Study Completion Date
    Recruitment Status by Participating Study Site 1
    Name of Study Eulji University Medical Center
    Recruitment Status Completed
    Date of First Enrollment 2014-11-11 ,
  • 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 Rural Development Administration
    Organization Type Government
    Project ID
  • 6. Sponsor Organization

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

    Study Summary Information
    Lay Summary
    The menopause is associated with an increase in women's health risks and abdominal fat distribution. It was reported that postmenopausal women had a 4.88-fold higher risk of developing abdominal obesity than premenopausal subjects. Prevention of weight gain from menopause is important to have a quality of healthy life for older women.
    Black rice is a type of colored rice that contains abundant anthocyanins in its outer layer.  Anthocyanins found in black rice are known to have various health benefits. In animal model showed that supplementation of black rice aleurone layer extract decreased fat mass and body weight and also prevented the reduction in bone strength and density.
    Therefore, The purpose of this study is to evaluate the effects of black rice extract supplement on body fat reduction and bone density in postmenopausal obese women aged 45-69 years old.
  • 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
    - Study Supplement : black rice extract(1g/day),  Placebo : maltodextrin(1g/day)
    During 12 weeks, take one capsule twice daily(2 capsules/d total) after breakfast and dinner
    Number of Arms 2
    Arm 1

    Arm Label

    Black rice extract(BRE) group

    Target Number of Participant

    50

    Arm Type

    Experimental

    Arm Description

    During 12 weeks, black rice extract(1g/day) take one capsule twice daily(2 capsules/d total) after breakfast and dinner
    Arm 2

    Arm Label

    Placebo group

    Target Number of Participant

    50

    Arm Type

    Placebo comparator

    Arm Description

    During 12 weeks, maltodextrin(1g/day) take one capsule twice daily(2 capsules/d total) after breakfast and dinner
  • 9. Subject Eligibility

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

    Obesity
    Rare Disease No
    Inclusion Criteria

    Gender

    Female

    Age

    45Year~69Year

    Description

    1) Postmenopausal women aged 45 to 69 y for 12 months without a menstrual period
    2) BMI (in kg/m2) ≧ 25.0
    3) Subjects who had never taken estrogen or drugs related to bone health or obesity in the last year
    4) Subjects who gave written informed consent
    Exclusion Criteria
    1) History of thyroid disease, diabetes, kidney disease or ovarian cancer that affect bone metabolism
    2) Current use of hormone replacement therapy
    3) Use of weight loss medication (absorption inhibitors, antidepressants, appetite suppressants, contraceptives, steroids, female hormones)
    4) Having participated in an obesity prevention programs or taken weight loss supplements within the last 3 months 
    5) Fasting blood glucose ≧ 126 mg/dl or blood glucose ≧ 200 mg/dl, or diabetic patients taking oral hypoglycemic agents or insulin
    6) History of heart, kidney, thyroid or cerebrovascular disease
    7) History of gallbladder disease, gastrointestinal disease, gout, or porphyria
    8) History of mental disorder such as schizophrenia, alcohol or drug abuse
    9) Hypersensitive reaction to any of the ingredients in the study supplements
    10) Unable to communicate or blind or hearing loss
    11) Unable to exercise from severe musculoskeletal disease
    12) History of cancer diagnosis or treatment within the last 5 years 
    13) History of asthma or other allergic diseases
    14) History of surgery within the last 1 year
    15) Having participation in other clinical trials within the last 3 months
    16) Unable to read letters
    17) Any other reasons unsuitable for the trial assessed by the investigator
    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
    Change of body fat amount and body fat % measured by dual-energy x-ray absorptiometry(DEXA)
    Timepoint
    Visit 2, Visit 5, Visit 8(Participants who agreed to extend research)
    Primary Outcome(s) 2
    Outcome
    Change of body fat amount and body fat % measured by computed tomography(CT)
    Timepoint
    Visit 2, Visit 5
    Primary Outcome(s) 3
    Outcome
    Weight, body mass index(BMI), mid-arm circumference(MAC), waist circumference, hip circumference, thigh circumference, waist hip ratio
    Timepoint
    Visit 1, Visit 3, Visit 4, Visit 5, Visit 6, Visit 7, Visit 8
    Primary Outcome(s) 4
    Outcome
    Change of body fat % measured by bioelectrical impedance analysis (BIA)
    Timepoint
    Visit 1, Visit 3, Visit 4, Visit 5, Visit 6, Visit 7, Visit 8
    Primary Outcome(s) 5
    Outcome
    Total Cholesterol, triglyceride, HDL-Cholesterol, LDL-Cholesterol
    Timepoint
    Visit 1, Visit 5
    Primary Outcome(s) 6
    Outcome
    Change of bone mineral density (BMD) measured by dual-energy x-ray absorptiometry(DEXA)
    Timepoint
    Visit 2, Visit 5, Visit 8(Participants who agreed to extend research)
    Primary Outcome(s) 7
    Outcome
    Urinary type I collagen telopeptide (NTx,CTx)
    Timepoint
    Visit 1, Visit 5
    Primary Outcome(s) 8
    Outcome
    Serum osteocalcin, calcium, ALP, BAP
    Timepoint
    Visit 1, Visit 5
    Secondary Outcome(s) 1
    Outcome
    Kupperman Index
    Timepoint
    Visit 1, Visit 5
    Secondary Outcome(s) 2
    Outcome
    Laboratory measurements
    Timepoint
    Visit 1, Visit 5
    Secondary Outcome(s) 3
    Outcome
    Adverse Event
    Timepoint
    Visit 3, Visit 4, Visit 5, Visit 6, Visit 7, Visit 8
    Secondary Outcome(s) 4
    Outcome
    Vital Signs
    Timepoint
    Visit 1, Visit 3, Visit 4, Visit 5, Visit 6, Visit 7, Visit 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 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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