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Background Information
1.Background  
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
 
Institutional Review Board Information
2. Institutional Review Board/Ethics Committee  
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  
- Address  
- Telephone  
Data Monitoring Committee No  
Contact Details
3.Contact Details  
Contact Person for Principal Investigator / Scientific Queries
- Name Oran Kwon 
- Title Ph.D 
- Telephone +82-2-3277-6860 
- Affiliation Ewha Womans University 
- Address 11-1, Daehyun-dong, Seodaemun-gu, Seoul  
Contact Person for Public Queries
- Name Jiyeon Kim 
- Title Ph.D 
- Telephone  
- Affiliation Ewha Womans 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 Womans University 
- Address A-504, Daesin-dong 85-1, Seodaemun-gu, Seoul  
Status
4. Status Status  
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 Site CHA University 
- Recruitment Status Completed  
- Date of First Enrollment 2011-09-06 , Actual
Source of Monetary / Material Support 정보
5. Source of Monetary/Material Support  
Source of Monetary/Material Support1 
- Organization Name Ministry of Science, ICT & Future Planning 
- Organization Type Government  
- Project ID  
Source of Monetary/Material Support2 
- Organization Name Daesang 
- Organization Type Others  
- Project ID  
Sponsor Organization
6. Sponsor Organization  
Sponsor Organization 1 
- Organization Name Ewha Womans University 
- Organization Type University  
Study Summary
7. Study Summary  
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
 
Study Design 정보
8. Study Design  
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
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  
Subject Eligibility Information
9. Subject  
Condition(s)/Problem(s) * Not Applicable
 
Rare Disease No
Inclusion
Criteria
Gender Both 
Age 20 Year ~ 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
Outcome Measure(s) Information
10. Outcome Measure(s)  
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 
Study Results and Publication Information
11. Study Results and Publication
Result Registerd  
Sharing of Study Data Information
12. Sharing of Study Data(Deidentified Individual-Patient Data, IPD)
Sharing Statement Not provided at time of Registration