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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000038702
Receipt No. R000044124
Scientific Title Effects of hojicha on the attention during driving: placebo-controlled single-blind crossover study
Date of disclosure of the study information 2019/12/02
Last modified on 2019/11/27

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Basic information
Public title Effects of hojicha on the attention during driving: placebo-controlled single-blind crossover study
Acronym Effects of hojicha on the attention during driving: placebo-controlled single-blind crossover study
Scientific Title Effects of hojicha on the attention during driving: placebo-controlled single-blind crossover study
Scientific Title:Acronym Effects of hojicha on the attention during driving: placebo-controlled single-blind crossover study
Region
Japan

Condition
Condition Not applicable
Classification by specialty
Not applicable Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The aim of this study is to investigate the effects of ingestion of hojicha on driving and attention using a driving simulator and eye tracker.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Behavior during driving after single ingestion
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Cross-over
Randomization Randomized
Randomization unit Individual
Blinding Single blind -participants are blinded
Control Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Prevention
Type of intervention
Food
Interventions/Control_1 single ingestion
Interventions/Control_2 two times
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
45 years-old <=
Age-upper limit
60 years-old >
Gender Male and Female
Key inclusion criteria 1) Age: 45 and over, less than 60
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) Non-smoker
6) Those who have not obtained a Type 2 driver's license
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)Those with eye abnormalities such as eye diseases
17)People with eye diseases such as "cataracts, infections, trauma, strabismus" within the past half year
18)Person wearing glasses when driving
19)People who use astigmatism or hard contacts while driving
20)Those who usually drive left-hand drive cars
21)Other than the above, the principal investigator judged that the subject was ineligible for the study.
Target sample size 20

Research contact person
Name of lead principal investigator
1st name Takanobu
Middle name
Last name Takihara
Organization ITO EN, Ltd
Division name Central Research Institute
Zip code 421-0516
Address 21 Mekami, Makinohara-shi, Shizuoka, Japan
TEL 0548-54-1247
Email t-takihara@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, Japan
TEL 0548-54-1247
Homepage URL
Email chika-yokoyama@itoen.co.jp

Sponsor
Institute Central Research Institute,ITO EN, Ltd
Institute
Department

Funding Source
Organization Central Research Institute, 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 12 Month 02 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
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 Preinitiation
Date of protocol fixation
2019 Year 11 Month 11 Day
Date of IRB
2019 Year 11 Month 14 Day
Anticipated trial start date
2019 Year 12 Month 05 Day
Last follow-up date
2019 Year 12 Month 27 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2019 Year 11 Month 27 Day
Last modified on
2019 Year 11 Month 27 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044124

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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