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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: KCT
Last refreshed on: 11 March 2019
Main ID:  KCT0000258
Date of registration: 2011-11-03
Prospective Registration: No
Primary sponsor: Ewha Womans University
Public title: Effect of chlorella consumption with egg loading on cholesterol levels in normocholesterolemic adults
Scientific title: Effect of four weeks consumption of chlorella with egg loading on cholesterol levels in normocholesterolemic adults: a randomized, double-blind, controlled study
Date of first enrolment: 2011-07-27
Target sample size: 34
Recruitment status: Completed
URL:  http://cris.nih.go.kr/cris/en/search/search_result_st01.jsp?seq=5467
Study type:  Interventional Study
Study design:  Primary Purpose : Others, Intervention Model : Parallel, Blinding/Masking : Double, Blinding Target : Subject, Investigator, Allocation : RCT  
Phase:  Not applicable
Countries of recruitment
Korea, Republic of
Contacts
Name: Jiyeon    Kim
Address: 
Telephone:
Email:
Affiliation:  Ewha Womans University
Name: Oran    Kwon
Address:  11-1, Daehyun-dong, Seodaemun-gu, Seoul
Telephone: +82-2-3277-6860
Email: oran151660@gmail.com
Affiliation:  Ewha Womans University
Key inclusion & exclusion criteria
Inclusion criteria: 1) Voluntarily agree to participate and signed in informed consent form
2) Adults aged 20 to 64 years.
3) Plasma total cholesterol levels below 200mg/dl

Exclusion criteria: 1) Continuous consumption of drug or dietary supplement that affect lipid metabolism within 4 weeks before the first visit
2) Following diseases:
? Myocardial infarction, stroke, uncontrolled hypertension (= 160/100mmHg)
? Diabetes (fasting plasma glucose = 126mg/dl)
? Liver failure(AST, ALT rose more than 2.5 times the upper limit of normal)
? Renal impairment (Creatinine rose more than 1.5 times the upper limit of normal)
? Hyperthyroidism and hypothyroidism
? Tumors
3) Familial hypercholesterolemia
4) Participation in another clinical trial within 4 weeks of first visit
5) Alcoholic
6) Pregnant or lactating women
7) Known allergies to eggs
8) Hypersensitivity to chlorella
9) Any condition that the principal investigator belives may put the subjects at undue risk


Age minimum: 20(Year)
Age maximum: 64(Year)
Gender: Both
Health Condition(s) or Problem(s) studied
Not Applicable
Intervention(s)
Dietary Supplement : 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
Primary Outcome(s)
Plasma total cholesterol levels
Secondary Outcome(s)
Plasma triglycerides, LDL-cholesterol, HDL-cholesterol, VLDL-cholesterol, Total cholesterol/HDL-cholesterol, HDL-cholesterol/LDL-cholesterol, lutein, zeaxanthin, alpha-carotene,beta-carotene,lycopene
Secondary ID(s)
Source(s) of Monetary Support
Daesang
Ministry of Science, ICT & Future Planning
Secondary Sponsor(s)
Ethics review
Status: Submitted approval
Approval date:
Contact:
Ewha Womans University Institutional Review Board
Results
Results available:
Date Posted:
Date Completed:
URL:
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