Tokyo, Dec. 6 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000059992) titled 'Investigation of the relaxing effects of functional aromatic components' on Dec. 6.
Study Type:
Interventional
Study Design:
Basic Design - Parallel
Randomization - Randomized
Blinding - Single blind -participants are blinded
Control - Placebo
Primary Sponsor:
Institute - Integrated Health Science Co., Ltd.
Condition:
Condition - Healthy person
Classification by malignancy - Others
Genomic information - NO
Objective:
Narrative objectives1 - Verification of the relaxing effects of aroma
Basic objectives2 - Efficacy
Intervention:
Interventions/Control_1 - Ingestion of the test beverage
Interventions/Control_2 - Ingestion of the control beverage
Eligibility:
Age-lower limit - 20
years-old
=
Gender - Female
Key inclusion criteria - 1. Healthy women aged 20 to 59.
2. Individuals who understand the contents of the informed consent explanation and can provide written consent voluntarily.
3. Individuals who do not meet the exclusion criteria.
Key exclusion criteria - 1. Individuals with a history of serious diseases of the brain, nervous system, cardiovascular system, renal failure or other severe disorders.
2. Individuals with a history of seizures (such as loss of consciousness, coma, or convulsions) due to neurological disorders.
3.Individuals who are currently under treatment or those taking prescribed medications.
4. Individuals who have difficulty performing essential evaluation items in this study due to hearing or visual impairments.
5. Individuals who have olfactory or gustatory dysfunction.
6. Individuals who are currently pregnant or breastfeeding.
7. Individuals who have Citrus allergy.
8. Individuals who consumed citrus fruits, their juices, or foods containing citric acid at least three times per week within the month prior to giving consent.
9. Individuals who consumed citrus fruits, their juices, or foods containing citric acid between 8:00 p.m. on the day before the test and the start of the test.
10. Individuals who are currently participating in another clinical trial, or who have participated in another clinical trial within one months prior to obtaining consent.
11. Individuals who cannot follow the instructions for infection prevention.
12. Individuals judged as inappropriate for participation by the principal investigator.
Target Size - 20
Recruitment Status:
Recruitment status - Preinitiation
Date of protocol fixation - 2025 Year 11 Month 25 Day
Date of IRB - 2025 Year 11 Month 25 Day
Anticipated trial start date - 2025 Year 12 Month 10 Day
Last follow-up date - 2025 Year 12 Month 31 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068601
Disclaimer: Curated by HT Syndication.
