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
CRIS Registration Number |
KCT0000259 |
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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
Board Approval Status | Submitted approval |
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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 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
Study Site | Single | |
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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
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
1. Sponsor Organization | |
---|---|
Organization Name | Ewha Womens University |
Organization Type | University |
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 |
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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 | 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
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)
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
Result Registered |
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12. Sharing of Study Data(Deidentified Individual-Patient Data, IPD)
Sharing Statement | Not provided at time of Registration |
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