UMIN-CTR Clinical Trial

Basic information
Public title	A study for the effect of intervention of aroma components on mood state (No.2103-014)- a placebo controlled, randomized, single-blind, parallel-group trial -
Acronym	A study for the effect of intervention of aroma components on mood state (No.2103-014)
Scientific Title	A study for the effect of intervention of aroma components on mood state (No.2103-014)- a placebo controlled, randomized, single-blind, parallel-group trial -
Scientific Title:Acronym	A study for the effect of intervention of aroma components on mood state (No.2103-014)
Region	Japan

Condition
Condition	Healthy subjects
Classification by specialty	Not applicable Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Evaluate the effects of inhaling aromas on mood state.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Profile of Mood States 1
Key secondary outcomes	Profile of Mood States 2 Sleep Quality Index Autonomic Nerve System Test Uchida-Kraepelin Test Olfactory Function Test

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Single blind -investigator(s) and assessor(s) are blinded
Control	Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Other
Interventions/Control_1	Inhalation of the test aroma twice a day for 15 days
Interventions/Control_2	Inhalation of control aroma twice a day for 15 days
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	65 years-old >
Gender	Male and Female
Key inclusion criteria	1)Healthy males and females equal to or more than 20 years and less than 65 years of age 2)Subjects who use Japanese as his/her primary language 3)Subjects who are working 4)Subjects who are aware of mental fatigue on a daily basis 5)Subjects who can use electronic diary application 6)Subjects who have received their second dose of COVID-19 vaccination and have a certificate of vaccination at the time of registration
Key exclusion criteria	1)Subjects who have, have a history, are suspected of having, and/or have a daily medication for the following items: sinusitis, allergic rhinitis (hay fever, etc.), psychiatric disorders (depression, anxiety disorders, etc.), sleep apnea syndrome, restless legs syndrome, insomnia, etc., sleep-related illness, chronic fatigue syndrome, arrhythmia, heart disease, menopausal disorders, history of serious illness (malignancy, diabetes, liver disease (hepatitis), renal disease, cardiac disease, etc.) 2)Subjects who have a difficulty to perform the tests due to a decline in olfactory function, sight, or hearing 3)Subjects with a cardiac pacemaker 4)Subjects who are receiving hormone therapy 5)Those who are judged to be unsuitable as subjects based on the results of the subject background investigation or preliminary examinations 6)Subjects who may have allergies or skin irritation caused by test fragrances or alcohol 7)Subjects who are, or are planning to be pregnant or breastfeeding during test periods 8)Subjects who have irregular lifestyles due to night work, etc. 9)Subjects who plan to travel abroad or go on overseas business trips 10)Subjects who consistently drink more than the appropriate amount of alcohol 11)Smoker, or has smoked within 12 months prior to preliminary examinations 12)Subjects who continuously consume medicines, health foods, food for specified health uses, food with nutrient function claims, or food with functional claims containing ingredients that may affect mood, fatigue, stress, sleep, or the autonomic nervous system at least once a week 13)Subjects who continuously use fragrances such as perfume, aroma diffuser, aroma spray, aroma bath, incense, etc. at least once a week 14)Subjects who have participated in other clinical trials within one month prior to the preliminary examinations or plan to participate during the study period 15)Subjects who are ineligible due to principal investigator's judgement
Target sample size	40

Research contact person
Name of lead principal investigator	1st name Kuniaki Middle name Last name Obara
Organization	Kirin Holdings Company, Limited
Division name	Kirin Central Research Institute, Research & Development Division
Zip code	251-8555
Address	Shonan Health Innovation Park , 26-1 Muraoka-Higashi 2-chome, Fujisawa, Kanagawa, Japan
TEL	080-1930-9932
Email	k-obara@kirin.co.jp

Public contact
Name of contact person	1st name Shigeru Middle name Last name Imai
Organization	Leverage Brain Inc.
Division name	Clinical Trial Department
Zip code	105-0004
Address	Shinbashi 2-16-1 Minato-ku, Tokyo, Japan
TEL	080-7290-0404
Homepage URL
Email	imai@levbrain.com

Sponsor
Institute	Leverage Brain Inc.
Institute
Department

Funding Source
Organization	Kirin Holdings Company Limited
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Japan Conference of Clinical Research
Address	1-13-23 Minamiikebukuro Toshima-ku, Tokyo, Japan
Tel	03-6868-7022
Email	jccr-info@cts-smo.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	茅場町こころのケアクリニック（東京都） Kayaba-cho Mental Health Care Clinic (Tokyo, Japan)

Other administrative information
Date of disclosure of the study information	2023 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	Completed
Date of protocol fixation	2021 Year 10 Month 27 Day
Date of IRB	2021 Year 11 Month 19 Day
Anticipated trial start date	2022 Year 01 Month 12 Day
Last follow-up date	2022 Year 02 Month 07 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded	2022 Year 10 Month 24 Day

Other
Other related information

Management information
Registered date	2022 Year 01 Month 05 Day
Last modified on	2022 Year 10 Month 25 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053102