Unique ID issued by UMIN | UMIN000038702 |
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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 |
Effects of hojicha on the attention during driving: placebo-controlled single-blind crossover study
Effects of hojicha on the attention during driving: placebo-controlled single-blind crossover study
Effects of hojicha on the attention during driving: placebo-controlled single-blind crossover study
Effects of hojicha on the attention during driving: placebo-controlled single-blind crossover study
Japan |
Not applicable
Not applicable | Adult |
Others
NO
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.
Efficacy
Behavior during driving after single ingestion
Interventional
Cross-over
Randomized
Individual
Single blind -participants are blinded
Placebo
2
Prevention
Food |
single ingestion
two times
45 | years-old | <= |
60 | years-old | > |
Male and Female
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
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.
20
1st name | Takanobu |
Middle name | |
Last name | Takihara |
ITO EN, Ltd
Central Research Institute
421-0516
21 Mekami, Makinohara-shi, Shizuoka, Japan
0548-54-1247
t-takihara@itoen.co.jp
1st name | Chika |
Middle name | |
Last name | Tagata |
ITO EN, Ltd
Central Research Institute
421-0516
21 Mekami, Makinohara-shi, Shizuoka, Japan
0548-54-1247
chika-yokoyama@itoen.co.jp
Central Research Institute,ITO EN, Ltd
Central Research Institute, ITO EN, Ltd.
Profit organization
Ethical review committee
3-47-10 Honmachi, shibuya-ku, Tokyo
03-5371-7195
k-murayama@itoen.co.jp
NO
2019 | Year | 12 | Month | 02 | Day |
https://center6.umin.ac.jp/cgi-open-bin/icdr/ctr_view_cb.cgi?recptno=R000044124&flwp_key=1005f2Nt3zc
Unpublished
https://center6.umin.ac.jp/cgi-open-bin/icdr/ctr_view_cb.cgi?recptno=R000044124&flwp_key=1005f2Nt3zc
14
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)
2022 | Year | 05 | Month | 30 | Day |
Delay expected |
In writing
Placebo group: age; 45-58 years old, male/female=6/8
hojicha group: age; 45-58 years old, male/female=6/8
Screening, n=40
Met inclusion criteria, n=16
/Allocation, n=15
Withdrawal,get travel-sick; n=1
Per protocol analysis, n=14
No adverse events
Behavior duriong driving (reaction time, eye movement etc), Cobnitrax
Completed
2019 | Year | 11 | Month | 11 | Day |
2019 | Year | 11 | Month | 14 | Day |
2019 | Year | 12 | Month | 05 | Day |
2019 | Year | 12 | Month | 27 | Day |
2020 | Year | 01 | Month | 16 | Day |
2020 | Year | 04 | Month | 09 | Day |
2020 | Year | 06 | Month | 04 | Day |
2019 | Year | 11 | Month | 27 | Day |
2022 | Year | 12 | Month | 01 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044124
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