Unique ID issued by UMIN | UMIN000050439 |
---|---|
Receipt number | R000057446 |
Scientific Title | Verification of the efficacy of the foods intake in VDT work in healthy adults. - A randomized, double-blind, placebo-controlled, crossover study- |
Date of disclosure of the study information | 2023/02/27 |
Last modified on | 2024/09/09 13:47:30 |
Verification of the efficacy of test foods intake in VDT work in healthy adults.
Verification of the efficacy of test foods intake in VDT work in healthy adults.
Verification of the efficacy of the foods intake in VDT work in healthy adults. - A randomized, double-blind, placebo-controlled, crossover study-
Verification of the efficacy of the foods intake in VDT work in healthy adults.
Japan |
Healthy subjects
Adult |
Others
NO
The purpose is to verify the effectiveness of test food intake in VDT work in healthy adults.
Efficacy
EEG, scores associated with VDT tasks, subjective evaluation(POMS2)
Interventional
Cross-over
Randomized
Individual
Double blind -all involved are blinded
Placebo
2
Prevention
Food |
A single administration of the test food is performed. After a washout period, a single administration of placebo is performed.
A single administration of the placebo is performed. After a washout period, a single administration of test food is performed.
18 | years-old | <= |
65 | years-old | > |
Male and Female
1. healthy men and women between the ages of 18 and 65 at the time of obtaining written consent
2. people who perform VDT work on a daily basis
a. taking medication or under medical treatment
b. pregnant, lactating, or intending to become pregnant during the study period
c. Minors (under 18 years of age)
d. under exercise therapy or dietetic therapy
e. allergic to test food
f. current dependence or history of either medicine or alcohol dependence syndrome
g. current or prior diagnosis of mental illness (depression) or sleep disturbance
h. extremely irregular lifestyle
i. on a night-shift or shift worker
j. unbalanced diet
k. current disease or history of brain disease, malignant tumor, immunological disease, diabetes, renal disease, cardiac disease, thyroid disease, adrenal disease, or other metabolic disease.
l. use of health foods, supplements, and medicines
m. participation in other clinical studies within the past 3 months from the day of consent or planning to participate in other clinical studies during the current study; n. considered as an inappropriate candidate by the doctor in charge.
9
1st name | Ryousuke |
Middle name | |
Last name | Furukado |
NISHINIPPON INSTITUTE OF TECHNOLOGY
Faculty of Engineering
8000344
1-11 Aratsu Kanda-machi Miyako-gun Fukuoka Japan
0930-23-1491
furukado@nishitech.ac.jp
1st name | Keita |
Middle name | |
Last name | Koga |
Pharma Foods International Co., Ltd.
Research and Development
6158245
1-49, Goryo-ohara, nishikyo-ku, Kyoto city, Kyoto, Japan
075-748-9829
k-koga@pharmafoods.co.jp
Pharama Foods International Co., Ltd.
Pharama Foods International Co., Ltd.
Profit organization
Ethics Committees of LittleSoftware
PLACEO Aoyama 3F, 2-7-13, Kita-Aoyama, Minato-ku, Tokyo, Japan
03-3789-6083
hhara@littlesoftware.jp
NO
2023 | Year | 02 | Month | 27 | Day |
https://center6.umin.ac.jp/cgi-open-bin/icdr/ctr_view.cgi?recptno=R000057446
Published
https://www2.aeplan.co.jp/jsnfs2024/document/program.pdf
9
Statistically significant difference was confirmed in the primary outcome.
2024 | Year | 09 | Month | 09 | Day |
1. healthy men and women between the ages of 18 and 65 at the time of obtaining written consent
2. people who perform VDT work on a daily basis
Enrolled(n=9)
Completed(n=9)
Analyzed(n=8)
No adverse events were observed that be related to test food.
EEG, scores associated with VDT tasks, subjective evaluation 
Completed
2023 | Year | 02 | Month | 17 | Day |
2023 | Year | 02 | Month | 21 | Day |
2023 | Year | 02 | Month | 28 | Day |
2023 | Year | 05 | Month | 31 | Day |
2023 | Year | 02 | Month | 27 | Day |
2024 | Year | 09 | Month | 09 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000057446