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Effect of four weeks consumption of chlorella with egg loading on cholesterol levels in normocholesterolemic adults: a randomized, double-blind, controlled study

Status Approved

First Submitted Date

2011/10/24
Registered Date

2011/11/03
Last Updated Date

2015/08/18

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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	KCT0000258
Unique Protocol ID	CHL_Daesang_1
Public/Brief 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
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 2011-3-5
Approval Date	2011-05-25
Institutional Review Board Name	Ewha Womans University Institutional Review Board
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
Recruitment Status by Participating Study Site 1
Study Site	Single
Overall Recruitment Status	Completed
Date of First Enrollment	2011-07-27 Actual
Target Number of Participant	34
Primary Completion Date	2011-11-17 , Actual
Study Completion Date	2011-11-17 , Actual
Name of Study	Ewha Womens University
Recruitment Status	Completed
Date of First Enrollment	2011-07-27 ,

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	Government

7. Study Summary

Study Summary Information
Lay Summary	- Purpose: The aim of this study is to evaluate the effect of chlorella consumption with high-cholesterol diet (egg-loading) on plasma cholesterol levels in adults - Subject: Adults with total cholesterol levels below 200mg/dl. - Intervention: After 4-weeks run-in period with low-cholesterol diet, subjects are randomly assigned to control or chlorella groups. Each group takes placebo or chlorella with high-cholesterol diet(egg-loading) for 4 weeks. - Biomarker: Plasma total cholesterol, triglyceride, LDL-cholesterol, HDL-cholesterol, VLDL-cholesterol, Total cholesterol/HDL-cholesterol, HDL-cholesterol/LDL-cholesterol, carotenoids(lutein, zeazanthin, alpha-carotene, beta-carotene, lycopene)

Study Summary Information

Lay Summary

- Purpose: The aim of this study is to evaluate the effect of chlorella consumption with high-cholesterol diet (egg-loading) on plasma cholesterol levels in adults 
- Subject: Adults with total cholesterol levels below 200mg/dl.
- Intervention: After 4-weeks run-in period with low-cholesterol diet, subjects are randomly assigned to control or chlorella groups. Each group takes placebo or chlorella with high-cholesterol diet(egg-loading) for 4 weeks. 
- Biomarker: Plasma total cholesterol, triglyceride, LDL-cholesterol, HDL-cholesterol, VLDL-cholesterol, Total cholesterol/HDL-cholesterol, HDL-cholesterol/LDL-cholesterol, carotenoids(lutein, zeazanthin, alpha-carotene, beta-carotene, lycopene)

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 17
	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 17
	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~64Year
	Description 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: ① Myocardial infarction, stroke, uncontrolled hypertension (≥ 160/100mmHg) 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 rose more than 1.5 times the upper limit of normal) ⑤ Hyperthyroidism and hypothyroidism ⑥ 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
Healthy Volunteers	Yes

10. Outcome Measure(s)

Outcome Measure(s) Information - Type of Primary Outcome, Primary Outcome, Outcome, Timepoint, Secondary Outcome, Outcome, Timepoint
Primary Outcome(s) 1
Type of Primary Outcome	Efficacy
Outcome	Plasma total cholesterol levels
Timepoint	0 and 4 weeks
Secondary Outcome(s) 1
Outcome	Plasma triglycerides, LDL-cholesterol, HDL-cholesterol, VLDL-cholesterol, Total cholesterol/HDL-cholesterol, HDL-cholesterol/LDL-cholesterol, lutein, zeaxanthin, alpha-carotene,beta-carotene,lycopene
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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