UMIN-CTR Clinical Trial

Recruitment status Completed
Unique ID issued by UMIN UMIN000035559
Receipt No. 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 (Ver. 5)

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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
Email 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
Email chika-yokoyama@itoen.co.jp

Sponsor
Institute ITO EN, LTD
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
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
Email 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000040509