UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000059814 |
|---|---|
| Receipt number | R000068397 |
| Scientific Title | Online Experiment on the Mood-Refreshing Effects of Beverages |
| Date of disclosure of the study information | 2025/11/25 |
| Last modified on | 2025/11/20 16:49:20 |
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Basic information
Public title
Online Experiment on the Mood-Refreshing Effects of Beverages
Acronym
Online Experiment on the Mood-Refreshing Effects of Beverages
Scientific Title
Online Experiment on the Mood-Refreshing Effects of Beverages
Scientific Title:Acronym
Online Experiment on the Mood-Refreshing Effects of Beverages
Region
| Japan |
Condition
Condition
Healthy males
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This experiment aims to obtain fundamental insights that can be applied to the development of new beverages. Healthy adult males will be recruited, and they will be asked to perform a task designed to induce stress. A short break for mood refreshment will be provided during the preparation phase of the task. During this break, participants will consume a designated beverage. Two beverage conditions will be prepared: one containing alcohol and one without alcohol. The assignment of beverage type will be determined randomly. By using this procedure, we aim to clarify whether alcohol acts as a positive means of mood refreshment under stress, or conversely, whether it has adverse effects. The findings will contribute to exploring new added value for future beverage development.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Psychological Scales (Subjective Stress, State Anxiety, Cognitive Emotion Regulation Strategies)
Before experiments, 5 minutes before the task instructions; 5 minutes before the speech preparation; Immediately after the speech preparation; 5 minutes before the mood-change task; Every 5 minutes after the mood-change task (4 measurements); 15 minutes before the debriefing
Key secondary outcomes
Heart Rate Measurement
5 minutes before the task instructions; 5 minutes before the speech preparation; Immediately after the speech preparation; 5 minutes before the mood-change task; Every 5 minutes after the mood-change task (4 measurements); 15 minutes before the debriefing
Upload status of the speech-preparation memo
Completion level of the speech preparation
Subjective intoxication and taste evaluation after beer consumption
Mood-change behaviors
Mindfulness assessment
After the mood-change task
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
| Food |
Interventions/Control_1
Beer Consumption Group:
Participants will consume two bottles of beer in total, drinking one bottle every 15 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_2
Control Group:
Participants will remain seated at rest.
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 of approximately 8 million registered individuals ranging in age from their teens to their seventies. This service regularly conducts web-based surveys and interviews to collect opinions on 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.
For this study, individuals registered with this service will serve as the target population.
Habitually consumes Asahi Super Dry beer at least once per month, without experiencing immediate discomfort or adverse health effects from consumption.
Non-smoker.
Does not exhibit alcohol flushing reactions.
Able to comfortably consume two 350 mL cans of 5% alcohol Asahi Super Dry beer within approximately 30 minutes (one can every ~15 minutes).
Able to store the study beverage (two 350 mL cans of Asahi Super Dry) in a refrigerator until the study session.
Able to participate in the study alone via Zoom from home on the day of the session.
Has a stable internet connection and can operate Zoom.
Able to measure heart rate using a smartphone app or, if not possible, a wearable device such as an Apple Watch, and provide real-time heart rate measurements.
Key exclusion criteria
Individuals who may experience adverse health effects from alcohol consumption.
Individuals who have been advised by a physician to limit alcohol intake, or who need to avoid alcohol due to medical conditions or medication use.
Individuals whose alcohol consumption habits exceed the cutoff score on the pre-screening questionnaire (AUDIT score >= 8, calculated from responses to questions 15-24).
Individuals who exhibit alcohol flushing reactions.
Current smokers.
Individuals for whom study conditions or environment cannot be adequately met (e.g., unstable internet connection, high levels of background noise, difficulty sitting for extended periods, inability to follow study instructions.)
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
takasemi@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
takasemi@nttdata-strategy.com
Sponsor or person
Institute
NTT DATA INSTITUTE OF MANAGEMENT CONSULTING,Inc.
Institute
Department
Personal name
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
takasemi@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
| 2025 | Year | 11 | Month | 25 | 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
| 2025 | Year | 11 | Month | 04 | Day |
Date of IRB
| 2025 | Year | 11 | Month | 13 | Day |
Anticipated trial start date
| 2025 | Year | 11 | Month | 29 | Day |
Last follow-up date
| 2025 | Year | 12 | Month | 19 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2025 | Year | 11 | Month | 18 | Day |
Last modified on
| 2025 | Year | 11 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068397
