UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000038702
Receipt number 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 2022/12/01 10:41:17

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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 or person

Institute

Central Research Institute,ITO EN, Ltd

Institute

Department

Personal name



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

https://center6.umin.ac.jp/cgi-open-bin/icdr/ctr_view_cb.cgi?recptno=R000044124&flwp_key=1005f2Nt3zc

Publication of results

Unpublished


Result

URL related to results and publications

https://center6.umin.ac.jp/cgi-open-bin/icdr/ctr_view_cb.cgi?recptno=R000044124&flwp_key=1005f2Nt3zc

Number of participants that the trial has enrolled

14

Results

In the "learning scene score" that evaluates the presence or absence of failure in the learning scene set in the driving course, in the hojicha intake group, the score improved significantly, compared to before the drink. (P <0.05)

Results date posted

2022 Year 05 Month 30 Day

Results Delayed

Delay expected

Results Delay Reason

In writing

Date of the first journal publication of results


Baseline Characteristics

Placebo group: age; 45-58 years old, male/female=6/8
hojicha group: age; 45-58 years old, male/female=6/8

Participant flow

Screening, n=40
Met inclusion criteria, n=16
/Allocation, n=15
Withdrawal,get travel-sick; n=1
Per protocol analysis, n=14

Adverse events

No adverse events

Outcome measures

Behavior duriong driving (reaction time, eye movement etc), Cobnitrax

Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

Completed

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

2020 Year 01 Month 16 Day

Date trial data considered complete

2020 Year 04 Month 09 Day

Date analysis concluded

2020 Year 06 Month 04 Day


Other

Other related information



Management information

Registered date

2019 Year 11 Month 27 Day

Last modified on

2022 Year 12 Month 01 Day



Link to view the page

Value
https://center6.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