UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Effects of green tea catechins on cholesterol synthesis/absorption markers in Japanese adults: a single-arm, open-label trial.
Title of the study (Brief title)	Effects of green tea catechins on cholesterol synthesis/absorption markers in Japanese adults: a single-arm, open-label trial.
Region	Japan

Condition
Condition	Borderline hyper LDL cholesterolemia
Classification by specialty	Cardiology Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The aim of this study is to investigate effects of the intake of green tea catechins on cholesterol synthesis/absorption markers.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Explanatory
Developmental phase	Not applicable

Assessment
Primary outcomes	Cholesterol synthesis and absorption markers(0, 4, and 8 wk)
Key secondary outcomes	1) Synthesis/absorption(0, 4, and 8 wk) 2) LDL-cholesterol(0, 4, and 8 wk) 3) HDL-cholesterol(0, 4, and 8 wk) 4) Total cholesterol(0, 4, and 8 wk) 5) LDL/HDL(0, 4, and 8 wk) 6) Correlation between changing rate of LDL-cholesterol and changing rate of each of cholesterol absorption and synthesis markers from baseline to 8 weeks

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification	NO
Dynamic allocation	NO
Institution consideration	Institution is not considered as adjustment factor.
Blocking	NO
Concealment	No need to know

Intervention
No. of arms	1
Purpose of intervention	Prevention
Type of intervention	Food
Interventions/Control_1	A green tea beverage was given twice a day at mealtimes for 8 weeks.
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	1) Subjects judged to be appropriate by the responsible physician 2) Subjects have a higher LDL- cholesterol in screening test (the responsible physician may exclude subjects with extremely low cholesterol absorption markers )
Key exclusion criteria	1) A history of malignant tumor, heart failure, or myocardial infarct 2) Currently under the treatment for either cardiac arrhythmia, hepatic disorder, renal disorder, cerebrovascular disorder, rheumatism, diabetes mellitus, dyslipidemia or hypertension 3) Subjects use or take "Foods for Specified Health Uses" and "Foods with Functional Claims" in daily 4) Currently taking medicines and/or herbal medicine 5) Those who are allergic to medicines and/or the test food related products 6) Pregnant, subjects with lactation period, or subjects having the mind to become pregnant in the test period 7) Subjects who participated in other clinical tests in 3 months before writing informed consent of this study was obtained 8) Subjects who are inadequate for enrollment judged by the responsible physician
Target sample size	20

Research contact person
Name of lead principal investigator	Yuko Sagesaka, PhD
Organization	ITO EN, Ltd.
Division name	Central Research Institute
Address	21 Mekami, Makinohara-shi, Shizuoka 421-0516, Japan
TEL	0548-54-1247
Email	y-sagesaka@itoen.co.jp

Public contact
Name of contact person	Makoto Kobayashi, PhD
Organization	ITO EN, Ltd.
Division name	Central Research Institute
Address	21 Mekami, Makinohara-shi, Shizuoka 421-0516, Japan
TEL	0548-54-1247
Homepage URL
Email	m-kobayasi@itoen.co.jp

Sponsor
Institute	Central Research Institute, ITO EN, Ltd.
Institute
Department

Funding Source
Organization	None
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor	Orthomedico Inc.
Name of secondary funｄer(s)	None

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions	医療法人社団盛心会 タカラクリニック

Other administrative information
Date of disclosure of the study information	2017 Year 10 Month 23 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2017 Year 09 Month 12 Day
Anticipated trial start date	2017 Year 09 Month 13 Day
Last follow-up date	2017 Year 12 Month 23 Day
Date of closure to data entry	2018 Year 01 Month 15 Day
Date trial data considered complete	2018 Year 02 Month 01 Day
Date analysis concluded	2018 Year 02 Month 28 Day

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2017 Year 09 Month 13 Day
Last modified on	2018 Year 03 Month 15 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000033310