UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000040787 |
|---|---|
| Receipt number | R000046572 |
| Scientific Title | Effects of matcha intake on cognitive function |
| Date of disclosure of the study information | 2020/06/19 |
| Last modified on | 2020/06/16 16:38:06 |
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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
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
akihiro.sasaki@riken.jp
Sponsor or person
Institute
RIKEN
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046572
