UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A clinical study to evaluate the effects of beverage containing green tea catechins on reducing LDL cholesterol
Title of the study (Brief title)	A clinical study to evaluate the effects of beverage containing green tea catechins on reducing LDL cholesterol
Region	Japan

Condition
Condition	None
Classification by specialty	Not applicable Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To investigate the effects of the intake of beverage containing green tea catechins for 12 weeks on reducing LDL cholesterol
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	LDL cholesterol
Key secondary outcomes	Total cholesterol, HDL cholesterol, LOX-index

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Double blind -all involved are blinded
Control	Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Food
Interventions/Control_1	Intake of beverage containing green tea catechins for 12 weeks
Interventions/Control_2	Intake of placebo for 12 weeks
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	65 years-old >
Gender	Male and Female
Key inclusion criteria	1) Subjects whose age of 20 years or more and less than 65 years 2) Subjects whose serum LDL cholesterol levels are 120 mg/dL or more and less than 140 mg/dL (borderline) or 140 mg/dL or more and less than 160 mg/dL (mild Hypercholesterolemia) in the screening examination 3) Subjects receiving a sufficient briefing of the objective and content of the present study, fully understanding and agreeing to voluntarily participate in the study and being able to personally sign a written informed consent
Key exclusion criteria	1) Subjects receiving a medical treatment for dyslipidemia 2) Subjects having serious hepatic, cardio-vascular, respiratory, endocrine or metabolic disorders 3) Subjects whose fasting serum triglyceride levels are 400 mg/dL or more 4) Subjects who have the possibility of developing allergic symptoms by the test food 5) Subjects who take Foods for Specified Health Uses or Foods with Function Claims labeled the effects of improving LDL cholesterol or total cholesterol levels 6) Subjects who take foods having the effects of improving LDL cholesterol or total cholesterol levels 7) Female subjects who are pregnant or lactating, or intending to be pregnant during the study 8) Female subjects who have menstrual irregularities 9) Subjects who have extremely irregular dietary habits, work in shifts or work during the night 10) Subjects having blood sample of 200 ml or more taken within 1 month, or 400 ml or more within 3 months prior to the start of the present study (e.g. donated blood) 11) Subjects who took part in another clinical study within 3 months prior to the start of the present study or who is currently taking part in another clinical study 12) Subjects deemed unsuitable by the investigator
Target sample size	140

Research contact person
Name of lead principal investigator	Takanobu Takihara
Organization	ITO EN, Ltd.
Division name	Central Research Institute
Address	21 Mekami, Makinohara, Shizuoka
TEL	0548-54-1247
Email	t-takihara@itoen.co.jp

Public contact
Name of contact person	Tomohiro Sugino
Organization	Soiken Inc.
Division name	Representative Director
Address	Senri Life Science Center 13F, 1-4-2, Shinsenri-higashimachi, Toyonaka, Osaka
TEL	06-6871-8888
Homepage URL
Email	sugino@soiken.com

Sponsor
Institute	Soiken Inc.
Institute
Department

Funding Source
Organization	ITO EN, Ltd.
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

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

Other administrative information
Date of disclosure of the study information	2019 Year 02 Month 09 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2017 Year 11 Month 18 Day
Anticipated trial start date	2018 Year 02 Month 12 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

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

Management information
Registered date	2018 Year 02 Month 09 Day
Last modified on	2019 Year 02 Month 13 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000035660