UMIN-CTR Clinical Trial

Basic information
Public title	A study for evaluating the LDL cholesterol reduction effect by ingestion of tea catechins containing beverage
Acronym	A study for evaluating the LDL cholesterol reduction effect by ingestion of tea catechins containing beverage
Scientific Title	A study for evaluating the LDL cholesterol reduction effect by ingestion of tea catechins containing beverage
Scientific Title:Acronym	A study for evaluating the LDL cholesterol reduction effect by ingestion of tea catechins containing beverage
Region	Japan

Condition
Condition	Healthy adult
Classification by specialty	Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	This study aims to evaluate the effects of ingestion of a beverage containing tea catechins on LDL cholesterol level for 12 weeks.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	LDL cholesterol
Key secondary outcomes	Total cholesterol

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	Prevention
Type of intervention	Food
Interventions/Control_1	Ingestion of test beverage containing tea catechins for 12 consecutive weeks
Interventions/Control_2	Ingestion of placebo beverage for 12 consecutive 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	Not applicable
Gender	Male and Female
Key inclusion criteria	(1)Males and females from 20 years of age (2)LDL cholesterol level is border area (120-139 mg/dL) or mild area (140-159 mg/dL) at preliminary examination
Key exclusion criteria	(1)Subjects who ingestion of a large amount tea catechins containing food (2)Subjects who have been ingesting any article (such as health food and medicine) that may affect serum lipid level or lipid metabolism (3)Subjects who has a disease under treatment or are judged to that medical treatment are necessary by the doctor (4)Subjects who has under treatment or a history of serious disease (e.g., diabetes, or liver disease, kidney disease, or heart disease) (5)The female of the menopause front where a menstrual cycle is irregular (besides 28days plus minus 4days) (6)Subjects having possibilities for emerging allergy related to the study (7)Serum triglyceride more than 400 mg/dL on preliminary examination (8)Subjects who are judged as unsuitable for the study based on the results of clinical and physical examination on preliminary examination (9)Subjects who are judged as unsuitable for the study based on the results of dietary habit questionnaire (10)Subjects who have participated in other clinical study within the last one month prior to the current study or are planned to participate in other clinical study after informed consent for the current study (11)Subjects who are judges as unsuitable for the study based on the results of lifestyle questionnaire (12)Subjects who are planned to become pregnant after informed consent for the current study or are pregnant or lactating (13)Subjects who are judged as unsuitable for the study by the investigator (subinvestigator) for other reason
Target sample size	120

Research contact person
Name of lead principal investigator	1st name Middle name Last name Yuuichi Ukawa
Organization	ITO EN,LTD
Division name	Central Research Institute
Zip code
Address	21,Mekami,Makinohara-city,Shizuoka
TEL	0548-54-1247
Email	y-ukawa@itoen.co.jp

Public contact
Name of contact person	1st name Middle name Last name Chiharu Goto
Organization	TTC Co.,Ltd.
Division name	Clinical Research Planning Department
Zip code
Address	1-20-2, Ebisunishi, Shibuya-ku, Tokyo
TEL	03-5459-5329
Homepage URL
Email	c.goto@ttc-tokyo.co.jp

Sponsor
Institute	TTC Co.,Ltd.
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)

IRB Contact (For public release)
Organization
Address
Tel
Email

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	2016 Year 07 Month 15 Day

Related information
URL releasing protocol
Publication of results	Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 07 Month 13 Day
Date of IRB	2016 Year 07 Month 13 Day
Anticipated trial start date	2016 Year 07 Month 16 Day
Last follow-up date	2017 Year 02 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2016 Year 07 Month 15 Day
Last modified on	2019 Year 11 Month 27 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026726