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A Randomized, Double-blind, Placebo-controlled Intervention Study to evaluate the Efficacy and Safety of “Barley Sprout” Extraction BS-1 in Healthy Volunteer with high cholesterol

Status Approved

First Submitted Date

2018/11/29
Registered Date

2019/01/17
Last Updated Date

2021/11/01

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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	KCT0003434
Unique Protocol ID	2018-08-097-004
Public/Brief Title	A Randomized, Double-blind, Placebo-controlled Intervention Study to evaluate the Efficacy and Safety of “Barley Sprout” Extraction BS-1 in Healthy Volunteer with high cholesterol
Scientific Title	A Randomized, Double-blind, Placebo-controlled Intervention Study to evaluate the Efficacy and Safety of “Barley Sprout” Extraction BS-1 in Healthy Volunteer with high cholesterol
Acronym	BS-1
MFDS Regulated Study	No
IND/IDE Protocol	No
Registered at Other Registry	No
Healthcare Benefit Approval Status	Not applicable

2. Institutional Review Board / Ethics Committee

Institutional Review Board Information
Board Approval Status	Submitted approval
Board Approval Number	KHUH 2018-08-097-004
Approval Date	2018-11-28
Institutional Review Board Name	Kyung Hee University Hospital IRB Membership
Institutional Review Board Address	23, Kyungheedae-ro, Dongdaemun-gu, Seoul
Institutional Review Board Telephone	02-958-9579
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	BO-HYUNG KIM
Title	Professor
Telephone	+82-2-958-2913
Affiliation	Kyung Hee University Hospital
Address	23, Kyungheedae-ro, Dongdaemun-gu, Seoul
Contact Person for Public Queries
Name	KEUM-RAN JEONG
Title	Researcher
Telephone	+82-2-958-2913
Affiliation	Kyung Hee University Hospital
Address	23, Kyungheedae-ro, Dongdaemun-gu, Seoul
Contact Person for Updating Information
Name	KEUM-RAN JEONG
Title	Researcher
Telephone	+82-2-958-2913
Affiliation	Kyung Hee University Hospital
Address	23, Kyungheedae-ro, Dongdaemun-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	2019-01-21 Actual
Target Number of Participant	78
Primary Completion Date	2020-12-16 , Actual
Study Completion Date	2020-12-16 , Actual
Name of Study	Kyung Hee University Hospital
Recruitment Status	Completed
Date of First Enrollment	2019-01-21 ,

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	MyongJi University Industry and Academia Cooperation Foundation
Organization Type	Others
Project ID	BS-1

6. Sponsor Organization

Sponsor Organization Information - Organization Name, Organization Type
1. Sponsor Organization
Organization Name	Kyung Hee University Hospital
Organization Type	Medical Institute

7. Study Summary

Study Summary Information
Lay Summary	To evaluate the Efficacy and Safety of “Barley Sprout” Extraction BS-1 in Healthy Volunteer with high cholesterol

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	Supportive Care
Phase	Not applicable
Intervention Model	Parallel
Blinding/Masking	Double
Blinded Subject	Subject, Investigator
Allocation	RCT
Intervention Type	Dietary Supplement
Intervention Description	After breakfast 30 minutes later take a capsule containing Barley Sprout extraction or Placebo for 12 weeks. - once a day, 2capsuls(1cap:500mg)/time (total 1,000mg)
Number of Arms	2
Arm 1	Arm Label Barley Sprout Group
	Target Number of Participant 39
	Arm Type Experimental
	Arm Description After breakfast 30 minutes later take a capsule containing Barley Sprout extraction for 12 weeks. - once a day, 2capsuls(1cap:500mg)/time
Arm 2	Arm Label Placebo comparator
	Target Number of Participant 39
	Arm Type Placebo comparator
	Arm Description Take a placebo for 12 weeks.(After breakfast 30 minutes later) - once a day, 2capsuls(1cap:500mg)/time

9. Subject Eligibility

Subject Eligibility Information
Condition(s)/Problem(s)	* (E00-E90)Endocrine, nutritional and metabolic diseases (E78.0)Pure hypercholesterolaemia Healthy Volunteer with high cholesterol
Rare Disease	No
Inclusion Criteria	Gender Both
	Age 20Year~79Year
	Description 1) Men and women aged 20 to under 79 2) 200 mg/dl ≤ Total cholesterol≤ 239 mg/dl 3) 130 mg/dl ≤ LDL cholesterol ≤ 159 mg/dl 4) Subjects who agree to participate in this study and have given their written informed consent
Exclusion Criteria	1) Currently taking drugs for the control of hyperlipidemia or the improvement of blood circulation 2) HDL cholesterol ≤ 40mg/dl 3) 200 mg/dl ≤ TG(Triglyceride) 4) Subjects who experienced adverse reactions such as allergies when taking sprouts barley products 5) Subjects who have a history of renal failure, liver disease (hepatitis, liver cirrhosis, liver cancer), psychiatric disorders such as dementia, major depression, generalized anxiety disorder 6) History or presence of clinically significant medical condition such as stroke, heart disease (heart failure, angina, myocardial infarction), malignant disease, narrow angle glaucoma, resistant hypertension, lung disease, systolic blood pressure greater than 180 mmHg in hypertension 7) Subjects who have clinical manifestation associated renal or hepatic disorders (serum creatinine > 2.0 mg/dL, liver function test: ALT, AST > 2.5 times of the upper limit of normal range) 8)Subjects who show the following results; - Fasting blood glucose 160 mg/dL, despite of taking oral antidiabetic agents - Platelet 150,000/mm3, WBC 3,000/mm3, Hemoglobin 9.5 g/dL for men or 9.0 g/dL for women 9) History or presence of any clinically significant medical condition such as hypertension, diabetes or smokers, (When two or more are applicable) 10) Use of the medications or products such as oral steroid, hormones within 12 weeks prior to the scheduled study drug administration. Subjects who have been taking medication or functional food, known to interfere with the absorption, metabolism and elimination of study drug (test food) or Subjects who participated in any other clinical trial within 3 months prior to the scheduled study drug administration 11) Subjects who have undergone surgical procedures within 6 months prior to the scheduled study drug administration or who have are taking medications (treatment for acupuncture or blood circulation improvement or health food,drug that may cause abuse) within 1 months prior to the scheduled study drug administration 12) Pregnant and lactating women 13) Subjects who do not follow informed-consent rules, or who are judged by the investigator to be inappropriate for inclusion in the study
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	/Safety/Efficacy
Outcome	LDL cholesterol reduction rate, total cholesterol reduction rate, HDL cholesterol change rate
Timepoint	0, 12 week(Visit 2, 4)
Secondary Outcome(s) 1
Outcome	Total cholesterol reduction amount, LDL cholesterol reduction amount, HDL cholesterol change amount, TG reduction ratio and reduction amount
Timepoint	0, 12 week(Visit 2, 4)
Secondary Outcome(s) 2
Outcome	Laboratory tests (hematology, blood biochemistry, urinalysis), Adverse event
Timepoint	0, 6, 12 week(Visit 2, 3, 4)

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	No

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	No

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