UMIN-CTR Clinical Trial

Basic information
Public title	Comparative study on LDL-cholesterol level using powdered green tea
Acronym	Comparative study on LDL-cholesterol level using powdered green tea
Scientific Title	Comparative study on LDL-cholesterol level using powdered green tea
Scientific Title:Acronym	Comparative study on LDL-cholesterol level using powdered green tea
Region	Japan

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

Objectives
Narrative objectives1	To investigate the effects of the intake of test food on LDL-cholesterol level
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	serum lipid
Key secondary outcomes	waist circumference, body fat percentage, blood glucose level, blood pressure, safety

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 test food for 12 consecutive weeks
Interventions/Control_2	Intake of placebo food 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	69 years-old >=
Gender	Male and Female
Key inclusion criteria	(1) Males and females from 20 to 64 years of age (2) Serum LDL- cholesterol level are ranged from 120 mg/dL to 139 mg/dL (3) Preferentially select women with menopause or stable menstrual cycle
Key exclusion criteria	(1) Subjects who routinely take foods or medicines affecting the test result (2) Subjects with fasting triglyceride value of 400 mg/dL or more (3) Subjects who have a disease requiring regular medication or a history of serious diseases for which medication was required (4) Subjects who have under treatment or a history of serious disease (e.g., diabetes, or liver disease, kidney disease, or heart disease) (5) Subjects who are judged as unsuitable for the study based on the results of lifestyle questionnaire (6) Subjects having possibilities for emerging allergy related to the study (7) Subjects who are judged as unsuitable for the study based on the results of clinical and physical examination on preliminary examination (8) Subjects participating in other clinical study (9) Females who are known or suspected to be pregnant, breastfeeding or desire to become pregnant during the trial period (10) Subjects who are judged unfit to enroll in this trial by the investigator
Target sample size	40

Research contact person
Name of lead principal investigator	1st name Masaharu Middle name Last name Ohkawara
Organization	Satoen Co., LTD.
Division name	none
Zip code	421-1392
Address	1057 Ohhara, Aoi-ku, Shizuoka, Japan
TEL	054-270-1336
Email	masaharu-ohkawara@satoen.co.jp

Public contact
Name of contact person	1st name Shinsuke Middle name Last name Tsuji
Organization	TTC Co., Ltd.
Division name	Clinical Research Planning Department
Zip code	150-0021
Address	Seibu Shinkin Bank Ebisu Bldg.,1-20-2, Ebisunishi, Shibuya-ku, Tokyo
TEL	03-5459-5329
Homepage URL
Email	s.tsuji@ttc-tokyo.co.jp

Sponsor
Institute	TTC Co., Ltd.
Institute
Department

Funding Source
Organization	Satoen Co., 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	Medical Station Clinic Research Ethics Committee
Address	3-12-8, Takaban, Meguroku, Tokyo
Tel	03-6452-2712
Email	t.saito@ttc-smo.jp

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	2020 Year 06 Month 12 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	2020 Year 05 Month 28 Day
Date of IRB	2020 Year 05 Month 28 Day
Anticipated trial start date	2020 Year 06 Month 15 Day
Last follow-up date	2020 Year 10 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2020 Year 06 Month 12 Day
Last modified on	2020 Year 11 Month 25 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046512