UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000063135 |
|---|---|
| Receipt number | R000072214 |
| Scientific Title | Online Experiment on the Mood-Refreshing Effects of Beverages Study2 |
| Date of disclosure of the study information | 2026/10/16 |
| Last modified on | 2026/09/30 18:44:26 |
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Basic information
Public title
Online Experiment on the Coping Effects of Non-Alcoholic Beer
Acronym
Online Experiment on the Coping Effects of Non-Alcoholic Beer
Scientific Title
Online Experiment on the Mood-Refreshing Effects of Beverages Study2
Scientific Title:Acronym
Online Experiment on the Mood-Refreshing Effects of Beverages Study2
Region
| Japan |
Condition
Condition
Healthy males
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study is expected to elucidate the psychological mechanisms underlying the consumption of non-alcoholic beer and mood-regulating behaviors under stressful conditions, thereby providing fundamental knowledge that may contribute to the development of novel beverages and the proposal of drinking behaviors that support the maintenance of psychological and physical well-being even under stressful circumstances.In addition, as a secondary objective, this study will explore how the selection of emotion regulation strategies changes in response to changes in stress levels.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Psychological measures (perceived stress and state anxiety)
Measurements will be conducted at the following time points: before the start of the trial; 5 minutes before the start of the task instructions; 5 minutes before speech preparation; 5 minutes before the post-speech mood-regulation task; every 5 minutes for a total of four measurements after the mood-regulation task; and 10 minutes before debriefing.
Key secondary outcomes
Psychological measures (subjective anxiety)
Measurements will be conducted at the following time points: before the start of the trial; 5 minutes before the start of the task instructions; 5 minutes before the start of speech preparation; 5 minutes before the post-speech mood-regulation task; every 5 minutes for a total of four measurements after the mood-regulation task; and 10 minutes before debriefing.
Upload status of the speech preparation notes, degree of completion of speech preparation, palatability rating of the beverage consumed, and mood-regulation behaviors.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Single blind -participants are blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Behavior,custom |
Interventions/Control_1
Non-alcoholic beer group:
Participants will consume one bottle of non-alcoholic beer every 15 minutes, for a total of two bottles over a 30-minute period.
Every 15 minutes, participants will be instructed to press the reaction button on Zoom to confirm that they have not left the screen.
Interventions/Control_2
Control Group:
Participants will remain seated at rest for 30 minutes.
To ensure that they remain present and in front of the screen, they will be instructed to click a Zoom reaction button every 10 minutes.
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
| 60 | years-old | > |
Gender
Male
Key inclusion criteria
Participants who indicate their willingness to participate and provide informed consent after understanding the study explanation will be included in the research.
In this study, participants will be recruited from the NTT Com Research Monitor, a panel managed by NTT Com Online Marketing Solutions. The NTT Com Research Monitor consists ofapproximately 8 million registered individuals ranging in age from their teens to their seventies. This service regularly conducts web-based surveys and interviews to collect opinionson systems, policies, and other topics. All registered members have agreed to the terms and conditions regarding information provision, including the handling of personal data,through NTT Com Research.
Participants must meet all of the following criteria:
1)Individuals who understand the contents of this study and provide consent to participate.
2)Healthy men aged 20 to 59 years.
3)Individuals who do not smoke.
4)Able to comfortably consume two 350-mL cans of non-alcoholic beer over approximately 30 minutes, at a rate of approximately one can every 15 minutes.
5)Able to store the study beverages in a refrigerator from the time of receipt until the day of the study. The study beverages consist of two 350-mL cans of Asahi ZERO non-alcoholic beer (alcohol content: 0.00%; amount of pure alcohol: 0 g).
6)Individuals who can participate in the study alone from their home via Zoom on the study day.
7)Individuals who have a stable internet connection and are able to use Zoom.
Key exclusion criteria
Individuals who meet any of the following criteria will be excluded:
1. Individuals whose alcohol consumption habits, assessed using the screening questionnaire, exceed the predefined threshold, specifically the AUDIT score of 8 or higher.
2. Individuals for whom alcohol consumption may cause adverse health effects.
3. Individuals who have been advised by a physician to restrict or avoid alcohol consumption, or who need to avoid alcohol consumption due to an underlying medical condition or medication use.
4. Individuals who currently smoke.
5. Individuals who may have difficulty meeting the study environment or study conditions, such as an unstable internet connection, excessive background noise, difficulty remainingseated for an extended period, or difficulty following study instructions.
6. Individuals who have previously participated in an online study on psychological tasks in interpersonal situations conducted by the research team, including the beer study conducted in December 2025 (UMIN Trial ID: UMIN000059814) and the music study conducted from June to July 2026 (UMIN Trial ID: UMIN000062040).
Target sample size
90
Research contact person
Name of lead principal investigator
| 1st name | Mina |
| Middle name | |
| Last name | Takase |
Organization
NTT DATA INSTITUTE OF MANAGEMENT CONSULTING,Inc.
Division name
Neuro-Cognitive Innovation Unit
Zip code
1020093
Address
JA Kyosai Bldg, 10th Fl., 7-9, Hirakawacho 2-chome, Chuyoda-ku Tokyo 102-0093, Japan
TEL
08013666354
takasraemi@nttdata-strategy.com
Public contact
Name of contact person
| 1st name | Mina |
| Middle name | |
| Last name | Takase |
Organization
NTT DATA INSTITUTE OF MANAGEMENT CONSULTING,Inc.
Division name
Neuro-Cognitive Innovation Unit
Zip code
1020093
Address
JA Kyosai Bldg, 10th Fl., 7-9, Hirakawacho 2-chome, Chuyoda-ku Tokyo 102-0093, Japan
TEL
08013666354
Homepage URL
takasraemi@nttdata-strategy.com
Sponsor or person
Institute
NTT DATA INSTITUTE OF MANAGEMENT CONSULTING,Inc.
Institute
Department
Personal name
Mina Takase
Funding Source
Organization
Asahi Quality and Innovations .Inc
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
NTT DATA INSTITUTE OF MANAGEMENT CONSULTING,Inc.
Address
JA Kyosai Bldg, 10th Fl., 7-9, Hirakawacho 2-chome, Chuyoda-ku Tokyo 102-0093, Japan
Tel
08013666354
takasraemi@nttdata-strategy.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
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 10 | Month | 16 | 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 | 09 | Month | 28 | Day |
Date of IRB
| 2026 | Year | 09 | Month | 10 | Day |
Anticipated trial start date
| 2026 | Year | 10 | Month | 16 | Day |
Last follow-up date
| 2027 | Year | 12 | 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 | 10 | Month | 01 | Day |
Last modified on
| 2026 | Year | 09 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000072214
