UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Effects of green tea consumption on cognitive dysfunction and atherosclerosis: A randomized-controlled study
Title of the study (Brief title)	Effects of green tea consumption on cognitive dysfunction and atherosclerosis
Region	Japan

Condition
Condition	Dementia
Classification by specialty	Neurology Geriatrics
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To investigate the effects of green tea consumption on cognitive dysfunction
Basic objectives2	Others
Basic objectives -Others	To investigate the effects of green tea consumption on the arteriosclerosis markers.
Trial characteristics_1	Exploratory
Trial characteristics_2	Others
Developmental phase	Not applicable

Assessment
Primary outcomes	Changes in Mini-Mental State Examination (MMSE) scores
Key secondary outcomes	Changes in sub-scores of MMSE Changes in BMI, blood pressure, serum lipids, plasma glucose, HbA1c

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Double blind -all involved are blinded
Control	Placebo
Stratification	YES
Dynamic allocation	NO
Institution consideration	Institution is not considered as adjustment factor.
Blocking	YES
Concealment	Central registration

Intervention
No. of arms	2
Purpose of intervention	Prevention
Type of intervention	Other
Interventions/Control_1	green tea powder
Interventions/Control_2	placebo powder
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	65 years-old <=
Age-upper limit	100 years-old >=
Gender	Male and Female
Key inclusion criteria	1.Obtained written informed consent from both the participant and care-giver before participation 2.Possible to consume green tea and placebo powder 3.Cognitive dysfunction based on MMSE; score < 28 4.Not taking any supplement possessing anti-oxidizing effects
Key exclusion criteria	1. Allergy to green tea 2. Severe cardiac, respiratory, renal, or hepatic dysfunction 3. Severe anemia 4. Diagnosed as inadequate to participate to the study by a doctor
Target sample size	30

Research contact person
Name of lead principal investigator	Hiroshi Yamada
Organization	University of Shizuoka
Division name	School of Pharmaceutical Sciences
Address	52-1 Yada, Suruga-ku, Shizuoka 422-8526, Japan
TEL	+81-54-264-5762
Email	hyamada@u-shizuoka-ken.ac.jp

Public contact
Name of contact person	Hiroshi Yamada
Organization	University of Shizuoka
Division name	School of Pharmaceutical Sciences
Address	52-1 Yada, Suruga-ku, Shizuoka 422-8526, Japan
TEL	+81-54-264-5762
Homepage URL	http://u-shizuoka-ken.ac.jp
Email	hyamada@u-shizuoka-ken.ac.jp

Sponsor
Institute	University of Shizuoka
Institute
Department

Funding Source
Organization	Central Research Institute, ITO EN, Ltd.
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization	Japan

Other related organizations
Co-sponsor	White Cross Nursing Home
Name of secondary funｄer(s)	Japanese Ministry of Health, Labor, and Welfare

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	静岡県立大学（静岡県）

Other administrative information
Date of disclosure of the study information	2013 Year 09 Month 09 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2013 Year 08 Month 05 Day
Anticipated trial start date	2013 Year 09 Month 10 Day
Last follow-up date	2015 Year 07 Month 31 Day
Date of closure to data entry	2015 Year 09 Month 30 Day
Date trial data considered complete	2015 Year 10 Month 31 Day
Date analysis concluded	2015 Year 12 Month 31 Day

Related information
URL releasing protocol	https://upload.umin.ac.jp/
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2013 Year 09 Month 06 Day
Last modified on	2017 Year 09 Month 10 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000013121