UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000063097 |
|---|---|
| Receipt number | R000072223 |
| Scientific Title | Investigation of the Effects of Aroma Associated with Citrus Model Beverage Consumption on VDT Work-Induced Stress in Young Women |
| Date of disclosure of the study information | 2026/09/30 |
| Last modified on | 2026/09/29 15:04:55 |
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Basic information
Public title
Effects of Drinking a Citrus-Flavored Model Beverage on Stress Caused by Computer Work in Young Women
Acronym
Citrus-Aroma Model Beverage Study on Computer Work-Related Stress
Scientific Title
Investigation of the Effects of Aroma Associated with Citrus Model Beverage Consumption on VDT Work-Induced Stress in Young Women
Scientific Title:Acronym
Citrus Model Beverage Aroma Study on VDT Work-Induced Stress
Region
| Japan |
Condition
Condition
Transient stress associated with VDT work
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aims to investigate the effects of citrus aroma perceived during the consumption of a citrus model beverage on recovery from transient psychological and physical stress and fatigue induced by VDT work in healthy young women, using physiological and psychological measures. Prior to the main trial, the validity of the VDT stress model and the assessment protocol will also be evaluated.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Change in the high-frequency component of heart rate variability from immediately after the VDT cognitive task to the end of the post-consumption recovery period. The change will be compared among three conditions: a citrus model beverage with added citrus flavor, a control model beverage without added citrus flavor, and mineral water. The primary pairwise comparison will be between the citrus model beverage with added citrus flavor and the control model beverage without added citrus flavor.
Key secondary outcomes
Changes in relaxation and fatigue assessed using visual analog scales from immediately after the VDT cognitive task to the end of the post-consumption recovery period will be treated as key secondary outcomes and compared among three conditions: a citrus model beverage with added citrus flavor, a control model beverage without added citrus flavor, and mineral water. The primary pairwise comparison will be between the citrus model beverage with added citrus flavor and the control model beverage without added citrus flavor. Other secondary outcomes will include heart rate, the low-frequency component and LF/HF ratio of heart rate variability, electroencephalographic measures, salivary amylase activity, critical flicker fusion frequency, mood and concentration assessed using visual analog scales, physical fatigue, and reaction time and accuracy during the VDT cognitive task.
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
Participants will consume a citrus model beverage with added citrus flavor once after completing the VDT cognitive task. Following consumption, participants will rest for a specified period, during which physiological and psychological outcomes will be assessed. This study will use a three-condition crossover design. Each participant will complete all three conditions, consisting of a citrus model beverage with added citrus flavor, a control model beverage without added citrus flavor, and mineral water, on separate study days in a randomized order.
Interventions/Control_2
Participants will consume a citrus model beverage with added citrus flavor once after completing the VDT cognitive task. Following consumption, participants will rest for a specified period, during which physiological and psychological outcomes will be assessed.
Interventions/Control_3
Participants will consume mineral water once after completing the VDT cognitive task. Following consumption, participants will rest for a specified period, during which physiological and psychological outcomes will be assessed.
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
| 18 | years-old | <= |
Age-upper limit
| 29 | years-old | >= |
Gender
Female
Key inclusion criteria
Participants must meet all of the following criteria:
1. Women aged 18 to 29 years
2. Students enrolled at Nakamura Gakuen University
3. Individuals who have received an adequate explanation of the study and provided written informed consent of their own free will
4. Individuals who are able to complete the VDT cognitive task, undergo the study assessments, and consume the study beverages according to the study protocol
5. Individuals judged by the principal investigator to be eligible to participate in the study
Key exclusion criteria
Individuals meeting any of the following criteria will be excluded:
1. Individuals with an allergy to any component of the study beverages or who are unwilling to consume the study beverages
2. Current smokers or individuals with excessive habitual alcohol consumption
3. Individuals who habitually consume functional foods or other products intended for stress reduction that may affect the study outcomes
4. Individuals who are pregnant or planning to become pregnant during the study period
5. Individuals with olfactory dysfunction or markedly impaired olfactory function due to severe rhinitis, pollinosis, or other conditions
6. Individuals with color vision deficiency or severe visual impairment that may interfere with completion of the VDT cognitive task
7. Individuals with cardiac disease, including arrhythmia, or who use medications that may affect autonomic nervous system activity
8. Individuals with a history of psychiatric or neurological disease, individuals currently receiving treatment for such conditions, or individuals using psychotropic drugs or hypnotics
9. Individuals with marked sleep deprivation, extreme fatigue, substantial physical discomfort associated with menstruation accompanied by bleeding, or any other poor physical condition on the day of assessment
10. Individuals participating in another human study at the start of this study, except for observational studies or other studies that are unlikely to affect the outcomes of the present study
11. Individuals otherwise judged by the principal investigator to be unsuitable for participation in the study
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Kenta |
| Middle name | |
| Last name | Yamamoto |
Organization
Nakamura Gakuen University
Division name
Faculty of Nutritional Sciences, Department of Food Management
Zip code
8140198
Address
5-7-1 Befu, Jonan-ku, Fukuoka
TEL
092-851-2531
yamaken@nakamura-u.ac.jp
Public contact
Name of contact person
| 1st name | Kenta |
| Middle name | |
| Last name | Yamamoto |
Organization
Nakamura Gakuen University
Division name
Faculty of Nutritional Sciences, Department of Food Management
Zip code
8140198
Address
5-7-1 Befu, Jonan-ku, Fukuoka
TEL
092-851-2531
Homepage URL
yamaken@nakamura-u.ac.jp
Sponsor or person
Institute
Nakamura Gakuen University
Institute
Department
Personal name
Funding Source
Organization
Nakamura Gakuen University
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
Nakamura Gakuen University
Address
5-7-1, Befu, Jounan-ku,Fukuoka, Japan
Tel
092-851-5579
kks@nakamura-u.ac.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
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 09 | Month | 30 | 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 | 04 | Month | 17 | Day |
Date of IRB
| 2026 | Year | 06 | Month | 18 | Day |
Anticipated trial start date
| 2026 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2029 | 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 | 09 | Month | 29 | Day |
Last modified on
| 2026 | Year | 09 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000072223
