UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000035559 |
|---|---|
| Receipt number | R000040509 |
| Scientific Title | Effects of matcha on cognitive function by driving simulator: a randomized, double-blind, parallel-group, comparative study |
| Date of disclosure of the study information | 2019/01/21 |
| Last modified on | 2021/01/18 10:20:32 |
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Basic information
Public title
Effects of matcha on cognitive function by driving simulator: a randomized, double-blind, parallel-group, comparative study
Acronym
Effects of matcha on cognitive function by driving simulator: a randomized, double-blind, parallel-group, comparative study
Scientific Title
Effects of matcha on cognitive function by driving simulator: a randomized, double-blind, parallel-group, comparative study
Scientific Title:Acronym
Effects of matcha on cognitive function by driving simulator: a randomized, double-blind, parallel-group, comparative study
Region
| Japan |
Condition
Condition
healthy adult
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to investigate effects of the intake of matcha on cognitive function by driving simulator.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Cognirtax
Behavior during driving(reaction time, eye movement etc)
Key secondary outcomes
NIRS, Olfactory test
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
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
12-week intake of the test food
Interventions/Control_2
12-week intake of the placebo food
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
| 60 | years-old | <= |
Age-upper limit
| 75 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1)Age: 60 and over, less than 75
2)Sex: Males and females with Japanese nationality
3)Those who are aware of a decline in cognitive function
4)Those who are driving on a daily basis
5)Those who can take 9 capsules a day for 12 weeks on a continuous basis
6)Non-smoker
Key exclusion criteria
1)Currently in treatment with medication or seeing a doctor for treatment
2)Previous history of hepatic disorder or severe disorder related to kidney, endocrine, cardiovascular system, gastro-intestine, lung, blood, or metabolism, or currently presence of complications
3)Previous history of drug allergy or food allergy
4)Regular intake of a food product or supplements with a possible influence on cognitive function
5)Regular intake of drug with a possible influence on cognitive function
6)Extreme faddiness
7)Extremely irregular lifestyle such as a dietary pattern and a sleeping pattern
8)Suspicion of insomnia
9)Presence or previous history of mental disorder (depression, etc.)
10)Presence or previous history of alcoholism
11)Current participation in another clinical trial or participation in another clinical trial within the last three months
12)Irregular work hours such as working on night shift
13)Those who received diagnosis of diseases related to dementia such as Alzheimer's disease, MCI
14)Pregnant
15)Hearing impaired person
16)Other than the above, the principal investigator judged that the subject was ineligible for the study.
Target sample size
16
Research contact person
Name of lead principal investigator
| 1st name | Chika |
| Middle name | |
| Last name | Tagata |
Organization
ITO EN, LTD
Division name
Central Research Institute
Zip code
421-0516
Address
21 Mekami, Makinohara-shi, Shizuoka 421-0516, Japan
TEL
81-548-54-1247
chika-yokoyama@itoen.co.jp
Public contact
Name of contact person
| 1st name | Chika |
| Middle name | |
| Last name | Tagata |
Organization
ITO EN, LTD
Division name
Central Research Institute
Zip code
421-0516
Address
21 Mekami, Makinohara-shi, Shizuoka 421-0516, Japan
TEL
81-548-54-1247
Homepage URL
chika-yokoyama@itoen.co.jp
Sponsor or person
Institute
ITO EN, LTD
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
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethical review committee
Address
3-47-10 Honmachi, shibuya-ku, Tokyo
Tel
03-5371-7195
k-murayama@itoen.co.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
| 2019 | Year | 01 | Month | 21 | Day |
Related information
URL releasing protocol
not releasing
Publication of results
Unpublished
Result
URL related to results and publications
not releasing
Number of participants that the trial has enrolled
14
Results
There were no significant
differences between placebo and matcha groups.
Results date posted
| 2020 | Year | 07 | Month | 22 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Placebo group: age; 61-71 years old, male/female=6/8
Matcha group: age; 60-70 years old, male/female=6/8
Participant flow
Screening, n=24
Met inclusion criteria, n=20
Allocation, placebo/matcha=9/10
Withdrawal(placebo),get travel-sick;1, missing primary outcome data;1
Withdrawal(matcha),get travel-sick;2,personal issue;1
Per protocol analysis, placebo/matcha=6/7
Adverse events
no adverse events
Outcome measures
Cognirtax
Behavior during driving(reaction time, eye movement etc)
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2018 | Year | 12 | Month | 17 | Day |
Date of IRB
| 2018 | Year | 12 | Month | 20 | Day |
Anticipated trial start date
| 2019 | Year | 01 | Month | 25 | Day |
Last follow-up date
| 2019 | Year | 03 | Month | 08 | Day |
Date of closure to data entry
| 2019 | Year | 03 | Month | 13 | Day |
Date trial data considered complete
| 2019 | Year | 03 | Month | 13 | Day |
Date analysis concluded
| 2019 | Year | 04 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2019 | Year | 01 | Month | 16 | Day |
Last modified on
| 2021 | Year | 01 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000040509
| Research Plan | |
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| Registered date | File name |
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