Clinical Trial: Investigation of the Effects of Aroma Associated with Citrus Model Beverage Consumption on VDT Work-Induced Stress in Young Women (Japan)

Tokyo, Sept. 30 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000063097) titled 'Effects of Drinking a Citrus-Flavored Model Beverage on Stress Caused by Computer Work in Young Women' on Sept. 30.

Study Type: Interventional

Study Design: Basic Design - Cross-over Randomization - Randomized Blinding - Open -but assessor(s) are blinded Control - Placebo

Primary Sponsor: Institute - Nakamura Gakuen University

Condition: Condition - Transient stress associated with VDT work Classification by malignancy - Others Genomic information - NO

Objective: 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

Intervention: 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.

Eligibility: Age-lower limit - 18 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 Size - 50

Recruitment Status: 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

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000072223

Disclaimer: Curated by HT Syndication.