UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000062022 |
|---|---|
| Receipt number | R000070968 |
| Scientific Title | Effect of the jelly drink with different purposes on behavior and physio-psychological status |
| Date of disclosure of the study information | 2026/07/01 |
| Last modified on | 2026/06/23 12:22:51 |
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Basic information
Public title
Effect of the jelly drink with different purposes on behavior and physio-psychological status
Acronym
Effect of the jelly drink with different purposes on behavior and physio-psychological status
Scientific Title
Effect of the jelly drink with different purposes on behavior and physio-psychological status
Scientific Title:Acronym
Effect of the jelly drink with different purposes on behavior and physio-psychological status
Region
| Japan |
Condition
Condition
Healthy adult
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Effect of the jelly drink with different purposes 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
Psychological index (Visual Analog Scale)
Key secondary outcomes
The result of the tracking task on PC, Facial expression during task (eyes closed), Physiological indicators (Blood Flow, Blood Volume, Heart Rate, LF/HF, TP)
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Placebo
Stratification
YES
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
jelly drink A, 1bag a day
Interventions/Control_2
jelly drink B, 1bag a day
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
| 59 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1) Full-time employee at Meiji Research Headquarters, Inc
2) Men and women aged 20~59 at the time of obtaining consent
3) Subjects who have the capacity to consent, have voluntarily volunteered and agreed to participate in this study after receiving sufficient explanation relating to this study
Key exclusion criteria
1) Subjects who take particular brand of jelly drink greater than or equal to two packs a week
2) Subjects who dislike jelly drink greater in general
3) Subjects who don't like the flavor of energy drinks
4) Subjects whose average sleep time during the week prior to obtaining consent was 4 hours or less
5) Subjects who take sleeping pills than or equal to onece a week
6) Subjects who are aware that their eyes are easily dry and use eye drops than or equal to four time a day to relieve
7) 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 | Mariko |
| Middle name | |
| Last name | Nihei |
Organization
Meiji Co., Ltd.
Division name
R&D Division Physical Properties&Kansei Research Unit
Zip code
192-0919
Address
1-29-1 Nanakuni, Hachioji, Tokyo, JAPAN
TEL
042-632-5866
mariko.nihei@meiji.com
Public contact
Name of contact person
| 1st name | Kahori |
| Middle name | |
| Last name | Hashimoto |
Organization
Meiji Co., Ltd.
Division name
R&D Division Physical Properties&Kansei Research Unit
Zip code
192-0919
Address
1-29-1 Nanakuni, Hachioji, Tokyo, JAPAN
TEL
042-632-5866
Homepage URL
kahori.hashimoto@meiji.com
Sponsor or person
Institute
Meiji Co., Ltd.
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
Meiji Institutional Review Board
Address
1-29-1 Nanakuni, Hachioji, Tokyo 192-0919, JAPAN
Tel
042-632-5900
MEIJI.IRB@meiji.com
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
株式会社 明治 明治イノベーションセンター / Meiji Co., Ltd. Meiji Innovation Center
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 07 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
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
Preinitiation
Date of protocol fixation
| 2026 | Year | 06 | Month | 17 | Day |
Date of IRB
| 2026 | Year | 06 | Month | 11 | Day |
Anticipated trial start date
| 2026 | Year | 07 | Month | 06 | Day |
Last follow-up date
| 2027 | Year | 03 | 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
| 2026 | Year | 06 | Month | 23 | Day |
Last modified on
| 2026 | Year | 06 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000070968
