UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000059812 |
|---|---|
| Receipt number | R000067517 |
| Scientific Title | Evaluation of Beverage Consumption Effects in the Context of Me-Time Activities |
| Date of disclosure of the study information | 2025/11/20 |
| Last modified on | 2025/11/18 15:55:16 |
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Basic information
Public title
Evaluation of Beverage Consumption Effects in the Context of Me-Time Activities
Acronym
Evaluation of Beverage Consumption Effects in the Context of Me-Time Activities
Scientific Title
Evaluation of Beverage Consumption Effects in the Context of Me-Time Activities
Scientific Title:Acronym
Evaluation of Beverage Consumption Effects in the Context of Me-Time Activities
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aims to exploratorily examine the psychological and behavioral effects of beverage characteristics during Me-Time, which is defined as habitual activities performed before bedtime on evenings preceding work or academic obligations. Findings from preliminary research suggest that the consumption of stimulating beverages, rather than those with relaxing properties, may enhance the perceived value of Me-Time for instance, by improving sleep quality.Through a three-week intervention, this study seeks to evaluate the efficacy of a newly developed beverage. The insights obtained will contribute to a deeper understanding of the role of beverages in everyday life and will inform future product development.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Productivity
Work-related stress
Mindfulness
Well-being
Affective states (pleasantness/unpleasantness)
Level of activity (or activation)
Satisfaction with Me-Time activities and time spent engaging in them
Psychological effects derived from Me-Time activities
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Non-randomized
Randomization unit
Blinding
Single blind -participants are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Food |
Interventions/Control_1
The control beverage (Drink P) used in this study is a non-sweetened drink without added flavoring agents, while the test beverage (Drink Q) is a non-sweetened drink containing the herbal flavoring agent nerol (Flavor X).
Nerol is approved as a food additive in Japan and is also recognized internationally as a food flavoring by the European Food Safety Authority (EFSA) and the Flavor and Extract Manufacturers Association (FEMA) in the United States. The acute oral toxicity (LD50) of nerol in rats is reported to be 4,500 mg/kg. In this study, Drink Q contains 6 mg of nerol per bottle, and participants will consume one bottle per day.
Interventions/Control_2
A beverage labeled with only functional claims in textual form (Drink R) versus a beverage labeled with marketing-oriented messaging (Drink S).
Interventions/Control_3
The control beverage (Drink T) used in this study is a sweetened drink without added flavoring agents, while the test beverage (Drink U) is a sweetened drink containing the herbal flavoring agent nerol (Flavor X).
Nerol is approved as a food additive in Japan and is also recognized internationally as a food flavoring by the European Food Safety Authority (EFSA) and the Flavor and Extract Manufacturers Association (FEMA) in the United States. The acute oral toxicity (LD50) of nerol in rats is reported to be 4,500 mg/kg. In this study, Drink U contains 6 mg of nerol per bottle, and participants will consume one bottle per day.
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 and Female
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.
Key exclusion criteria
Individuals who experience discomfort when consuming beverages containing herbal flavoring, which is a characteristic of the target drink in this study; those who find carbonated beverages unpleasant; and those who may have difficulty engaging in activities in accordance with the experimental conditions will be excluded from participation.
Target sample size
100
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 | 20 | 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
90
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
No longer recruiting
Date of protocol fixation
| 2025 | Year | 08 | Month | 27 | Day |
Date of IRB
| 2025 | Year | 10 | Month | 03 | Day |
Anticipated trial start date
| 2025 | Year | 10 | Month | 03 | 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
| 2025 | Year | 12 | Month | 19 | Day |
Other
Other related information
Management information
Registered date
| 2025 | Year | 11 | Month | 18 | Day |
Last modified on
| 2025 | Year | 11 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000067517
