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Effect of four weeks consumption of chlorella on cholesterol levels in mildly hypercholesterolemic adults : a randomized, double-blind, controlled study

Status Approved

  • First Submitted Date

    2011/10/26

  • Registered Date

    2011/11/03

  • Last Updated Date

    2015/08/18

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
    KCT0000259
    Unique Protocol ID CHL_Daesang_2
    Public/Brief Title Effect of chlorella consumption on cholesterol levels in mildly hypercholesterolemic adults
    Scientific Title Effect of four weeks consumption of chlorella on cholesterol levels in mildly hypercholesterolemic adults : a randomized, double-blind, controlled study
    Acronym
    MFDS Regulated Study Yes
    IND/IDE Protocol No
    Registered at Other Registry No
    Healthcare Benefit Approval Status
  • 2. Institutional Review Board / Ethics Committee

    Institutional Review Board Information
    Board Approval Status Submitted approval
    Board Approval Number IRB 2011-3-4
    Approval Date 2011-05-25
    Institutional Review Board Name Ewha Womans University IRB
    Institutional Review Board Address
    Institutional Review Board Telephone
    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 Ph.D
    Telephone +82-2-3277-6860
    Affiliation Ewha Womens University
    Address 11-1, Daehyun-dong, Seodaemun-gu, Seoul
    Contact Person for Public Queries
    Name Jiyeon Kim
    Title Ph.D
    Telephone +82-2-3277-3094
    Affiliation Ewha Womens University
    Address 11-1, Daehyun-dong, Seodaemun-gu, Seoul
    Contact Person for Updating Information
    Name Joohee Kim
    Title Ph.D
    Telephone +82-2-364-0839
    Affiliation Ewha Womens University
    Address A-504, Daesin-dong 85-1, 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 Completed
    Date of First Enrollment 2011-09-06 Actual
    Target Number of Participant 68
    Primary Completion Date 2012-02-24 , Actual
    Study Completion Date 2012-02-24 , Actual
    Recruitment Status by Participating Study Site 1
    Name of Study CHA University
    Recruitment Status Completed
    Date of First Enrollment 2011-09-06 ,
  • 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 Ministry of Science, ICT & Future Planning
    Organization Type Government
    Project ID
    2. Source of Monetary/Material Support
    Organization Name Daesang
    Organization Type Others
    Project ID
  • 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
    - Purpose: The aim of this study is to evaluate the effect of chlorella consumption on plasma cholesterol levels in midly hypercholesterolemic adults 
    - Subject: Adults with total cholesterol levels ≥ 200mg/dl and < 250mg/dl. 
    - Intervention: After run-in period less than 2 weeks, subjects are randomly assigned to control or chlorella groups. Each group takes placebo or chlorella for 4 weeks. 
    - Biomarker: Plasma total cholesterol, triglyceride, LDL-cholesterol, HDL-cholesterol, VLDL-cholesterol, Total cholesterol/HDL-cholesterol, HDL-cholesterol/LDL-cholesterol,Apo A1, Apo B, Apo E, LCAT, CETP, carotenoids(lutein, zeazanthin, alpha-carotene, beta-carotene, lycopene), fasting blood glucose, glycated albumin  
    
  • 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
    Chlorella group: Consumption of chlorella tablets, 3 times/day, 4 tablets/time(chlorella 5g/day) 
    Control group: Consumption of plcebo, 3 times/day, 4 tablets/time
    Number of Arms 2
    Arm 1

    Arm Label

    Chlorella group

    Target Number of Participant

    34

    Arm Type

    Experimental

    Arm Description

    Four weeks consumption of chlorella tablets, 3 times/day, 4 tablets/time(chlorella 5g/day)  
    Arm 2

    Arm Label

    Control group

    Target Number of Participant

    34

    Arm Type

    Placebo comparator

    Arm Description

    Four weeks consumption of placebo, 3 times/day, 4 tablets/time 
  • 9. Subject Eligibility

    Subject Eligibility Information
    Condition(s)/Problem(s) * (E00-E90)Endocrine, nutritional and metabolic diseases 
       (E78.08)Other and unspecified Pure hypercholesterolaemia 
    Rare Disease No
    Inclusion Criteria

    Gender

    Both

    Age

    20Year~No Limit

    Description

    1) Voluntarily agree to participate and signed in informed consent form 
    2) Adults aged over 20 years 
    3) Plasma total cholesterol levels ≥ 200mg/dl and < 250mgl/dl  
    Exclusion Criteria
    1) Continuous consumption of drug or dietary supplement that affect lipid metabolism within 4 weeks before the first visit (statin, fibrate, beta-blocker, etc)
    2) Following diseases: 
    ① Myocardial infarction, stroke, uncontrolled hypertension (≥ 140/90mmHg) 
    ② Diabetes (fasting plasma glucose ≥ 126mg/dl) 
    ③ Liver failure(AST, ALT rose more than 2.5 times the upper limit of normal) 
    ④ Renal impairment (Creatinine ≥ 1.4mg/dl) 
    ⑤ Hyperthyroidism and hypothyroidism 
    ⑥ Malignant tumors 
    3) Familial hypercholesterolemia 
    4) Participation in another clinical trial within 4 weeks of first visit 
    5) Alcoholic 
    6) Pregnant or lactating women 
    7) Hypersensitivity to chlorella 
    8) Any condition that the principal investigator belives may put the subjects at undue risk  
    
    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
    Plasma total cholesterol levels 
    Timepoint
    0 and 4 weeks
    Secondary Outcome(s) 1
    Outcome
    Triglycerides,LDL-cholesterol,HDL-cholesterol,VLDL-cholesterol,Total cholesterol/HDL-cholesterol, HDL-cholesterol/LDL-cholesterol,ApoA1,ApoB,ApoE,LCAT,CETP,carotenoids,fastingbloodglucose, etc
    Timepoint
    0 and 4 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
  • 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 Not provided at time of Registration
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