UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000041203 |
|---|---|
| Receipt number | R000047047 |
| Scientific Title | Exploratory study: effect of intake of JNS on behavior and physio-psychological status. |
| Date of disclosure of the study information | 2020/07/24 |
| Last modified on | 2021/02/03 11:49:46 |
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Basic information
Public title
Exploratory study: Effect of intake of the Jellied Nutritional Supplement on behavior and physio-psychological status.
Acronym
Exploratory study: effect of intake of JNS on behavior and physio-psychological status.
Scientific Title
Exploratory study: effect of intake of JNS on behavior and physio-psychological status.
Scientific Title:Acronym
Exploratory study: effect of intake of JNS on behavior and physio-psychological status.
Region
| Japan |
Condition
Condition
Healthy adult male
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Effect of intake of JNS on body and mind status during and after performing the stress task.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
The result of the circle tracking task on PC,Physiological indicators(Mean blood pressure,Heart rate,Cardiac output,Stroke volume,Total peripheral resistance,The temperature of the facial skin,alpha-wave),Psychological index (Short version of Profile of Mood States(ver2),Visual Analog Scale,Free description questionnaire)
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
NO
Dynamic allocation
NO
Institution consideration
Blocking
NO
Concealment
Pseudo-randomization
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
JNS,1bag a day
Interventions/Control_2
No intervention
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male
Key inclusion criteria
1) Students or staff from Aoyama Gakuin University Faculty of Science and Engineering or Graduate School of Science and Engineering of Aoyama Gakuin University.
2) Men not younger than 20 years old (at the time of informed consent)
3) Subjects who agree to participate in this study with a written informed consent after receiving sufficient explanation relating to this study.
Key exclusion criteria
1) Subjects who take JNS greater than or equal to one pack a week.
2) Subjects whose sleeping hours is less than 4 on average a week.
3) Subjects use sleeping pills on a daily basis.
4)Subjects who are judged unsuitable for this study by the principal investigator.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Akio |
| Middle name | |
| Last name | Nozawa |
Organization
Aoyama Gakuin University
Division name
College of Science and Engineering Department of Electrical Engineering and Electronics
Zip code
252-5258
Address
5-10-1 Fuchinobe, Chuo-ku, Sagamihara, Kanagawa 252-5258, Japan
TEL
042-759-6262
akio@ee.aoyama.ac.jp
Public contact
Name of contact person
| 1st name | Yoshio |
| Middle name | |
| Last name | Toyama |
Organization
Meiji Co., Ltd
Division name
R&D division
Zip code
192-0919
Address
1-29-1 Nanakuni, Hachioji, Tokyo 192-0919, Japan
TEL
042-632-5824
Homepage URL
yoshio.toyama@meiji.com
Sponsor or person
Institute
Aoyama Gakuin University
College of Science and Engineering
Department of Electrical Engineering and Electronics
Institute
Department
Personal name
Funding Source
Organization
Meiji Co., Ltd
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
The ethics committee of Aoyama Gakuin University
Address
5-10-1 Fuchinobe, Chuo-ku, Sagamihara, Kanagawa 252-5258, Japan
Tel
042-759-6056
hito-rinri@aoyamagakuin.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
青山学院大学（神奈川県）
（Aoyama Gakuin University）
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 07 | Month | 24 | Day |
Related information
URL releasing protocol
https://isarob.org/symposium/
Publication of results
Published
Result
URL related to results and publications
https://isarob.org/symposium/
Number of participants that the trial has enrolled
24
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
Completed
Date of protocol fixation
| 2020 | Year | 03 | Month | 18 | Day |
Date of IRB
| 2020 | Year | 03 | Month | 18 | Day |
Anticipated trial start date
| 2020 | Year | 07 | Month | 17 | Day |
Last follow-up date
| 2020 | Year | 10 | Month | 02 | Day |
Date of closure to data entry
| 2020 | Year | 11 | Month | 10 | Day |
Date trial data considered complete
| 2020 | Year | 11 | Month | 10 | Day |
Date analysis concluded
| 2020 | Year | 12 | Month | 17 | Day |
Other
Other related information
Management information
Registered date
| 2020 | Year | 07 | Month | 24 | Day |
Last modified on
| 2021 | Year | 02 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047047
