UMIN-CTR Clinical Trial
| 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 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Verification of the efficacy of test foods intake in VDT work in healthy adults.
Acronym
Verification of the efficacy of test foods intake in VDT work in healthy adults.
Scientific Title
Verification of the efficacy of the foods intake in VDT work in healthy adults. - A randomized, double-blind, placebo-controlled, crossover study-
Scientific Title:Acronym
Verification of the efficacy of the foods intake in VDT work in healthy adults.
Region
| Japan |
Condition
Condition
Healthy subjects
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose is to verify the effectiveness of test food intake in VDT work in healthy adults.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
EEG, scores associated with VDT tasks, subjective evaluation(POMS2)
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved 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
A single administration of the test food is performed. After a washout period, a single administration of placebo is performed.
Interventions/Control_2
A single administration of the placebo is performed. After a washout period, a single administration of test food is performed.
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
| 18 | years-old | <= |
Age-upper limit
| 65 | years-old | > |
Gender
Male and Female
Key inclusion criteria
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
Key exclusion criteria
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.
Target sample size
9
Research contact person
Name of lead principal investigator
| 1st name | Ryousuke |
| Middle name | |
| Last name | Furukado |
Organization
NISHINIPPON INSTITUTE OF TECHNOLOGY
Division name
Faculty of Engineering
Zip code
8000344
Address
1-11 Aratsu Kanda-machi Miyako-gun Fukuoka Japan
TEL
0930-23-1491
furukado@nishitech.ac.jp
Public contact
Name of contact person
| 1st name | Keita |
| Middle name | |
| Last name | Koga |
Organization
Pharma Foods International Co., Ltd.
Division name
Research and Development
Zip code
6158245
Address
1-49, Goryo-ohara, nishikyo-ku, Kyoto city, Kyoto, Japan
TEL
075-748-9829
Homepage URL
k-koga@pharmafoods.co.jp
Sponsor or person
Institute
Pharama Foods International Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
Pharama Foods International Co., 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
Ethics Committees of LittleSoftware
Address
PLACEO Aoyama 3F, 2-7-13, Kita-Aoyama, Minato-ku, Tokyo, Japan
Tel
03-3789-6083
hhara@littlesoftware.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
| 2023 | Year | 02 | Month | 27 | Day |
Related information
URL releasing protocol
https://center6.umin.ac.jp/cgi-open-bin/icdr/ctr_view.cgi?recptno=R000057446
Publication of results
Published
Result
URL related to results and publications
https://www2.aeplan.co.jp/jsnfs2024/document/program.pdf
Number of participants that the trial has enrolled
9
Results
Statistically significant difference was confirmed in the primary outcome.
Results date posted
| 2024 | Year | 09 | Month | 09 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
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
Participant flow
Enrolled(n=9)
Completed(n=9)
Analyzed(n=8)
Adverse events
No adverse events were observed that be related to test food.
Outcome measures
EEG, scores associated with VDT tasks, subjective evaluation　
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2023 | Year | 02 | Month | 17 | Day |
Date of IRB
| 2023 | Year | 02 | Month | 21 | Day |
Anticipated trial start date
| 2023 | Year | 02 | Month | 28 | Day |
Last follow-up date
| 2023 | Year | 05 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2023 | Year | 02 | Month | 27 | Day |
Last modified on
| 2024 | Year | 09 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000057446
