UMIN-CTR Clinical Trial

Basic information
Public title	Effects of matcha intake on cognitive function
Acronym	Effects of matcha intake on cognitive function
Scientific Title	Effects of matcha intake on cognitive function
Scientific Title:Acronym	Effects of matcha intake on cognitive function
Region	Japan

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

Objectives
Narrative objectives1	To examine the effects of continuous intake of matcha on cognitive function.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Explanatory
Developmental phase	Not applicable

Assessment
Primary outcomes	Comparison of brain structure and task-related brain activity before and 12 weeks after starting test food intake
Key secondary outcomes	Comparison of cognitive function (Cognitrax, CogEvo-Ri), autonomic nervous function, questionnaires (BDI-II, STAI, NEO-FFI) and daily mood survey (KOKORO scale) before and 12 weeks after starting test food intake

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	Central registration

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Food
Interventions/Control_1	Intake test food (2g/day for matcha) for twelve weeks
Interventions/Control_2	Intake placebo for twelve 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	40 years-old <=
Age-upper limit	60 years-old >
Gender	Male and Female
Key inclusion criteria	1) Individual who has received sufficient explanation about purpose and content of research, and consenting ability, and who volunteers with his/her free intent and gives written informed consent. 2) Healthy adults between the ages of 40 and under 60 at the time of informed consent.
Key exclusion criteria	1) Subject who uses life support device inside or outside the body 2) Subject with a metallic foreign body inside 3) Subjects using orthodontic metal bridges 4) Subjects using tattoos, eye lines, fashion contact lenses 5) Subjects who were engaged in the metalworking industry 6) Subjects with mental/neurotic attacks or claustrophobia 7) Subjects with impaired hearing, vocalization, or grip strength 8) Subjects with disorders in body temperature regulation and sweating 9) Subjects who have been previously pointed out to have arrhythmia by physical examination. 10) Subjects with an MMSE score of 24 or less. 11) Subjects who cannot perform a computer-based cognitive function test satisfactorily. 12) Subjects who are inadequate for enrollment judged by the responsible physician
Target sample size	60

Research contact person
Name of lead principal investigator	1st name Yasuyoshi Middle name Last name Watanabe
Organization	RIKEN
Division name	Laboratory for Pathophysiological and Health Science
Zip code	650-0047
Address	6-7-1, Minatojimaminami-machi, Chuo-ku, Kobe, Hyogo 650-0047, Japan
TEL	81-78-569-8868
Email	yywata@riken.jp

Public contact
Name of contact person	1st name Akihiro Middle name Last name Sasaki
Organization	RIKEN Center for Biosystems Dynamics Research
Division name	Laboratory for Pathophysiological and Health Science
Zip code	650-0047
Address	6-7-1, Minatojimaminami-machi, Chuo-ku, Kobe, Hyogo 650-0047, Japan
TEL	81-78-569-8868
Homepage URL
Email	akihiro.sasaki@riken.jp

Sponsor
Institute	RIKEN
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	ITO EN, Ltd.
Name of secondary funder(s)

IRB Contact (For public release)
Organization	RIKEN Kobe Institute Safety Center
Address	-2-3 Minatojima-minamimachi, Chuo-ku, Kobe, Hyogo 650-0047, Japan
Tel	078-306-3036
Email	kobe-ankan@cdb.riken.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 19 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	60
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	2019 Year 07 Month 10 Day
Date of IRB	2019 Year 08 Month 02 Day
Anticipated trial start date	2019 Year 08 Month 22 Day
Last follow-up date	2020 Year 12 Month 31 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 16 Day
Last modified on	2020 Year 06 Month 16 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046572