UMIN-CTR Clinical Trial

Basic information
Public title	Verification of the effect of aroma on exercise characteristics-Group comparison study-
Acronym	Verification of the effect of aroma on exercise characteristics
Scientific Title	Verification of the effect of aroma on exercise characteristics-Group comparison study-
Scientific Title:Acronym	Verification of the effect of aroma on exercise characteristics
Region	Japan

Condition
Condition	Healthy
Classification by specialty	Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Verification of changes in exercise characteristics by aroma
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Exercise test (Odorless control,Aroma A,Aroma B)
Key secondary outcomes	Psychological examination (Odorless control,Aroma A,Aroma B)

Base
Study type	Interventional

Study design
Basic design	Cross-over
Randomization	Randomized
Randomization unit	Individual
Blinding	Single blind -participants are blinded
Control	No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	3
Purpose of intervention	Prevention
Type of intervention	Other
Interventions/Control_1	Aroma A:Sticker Once
Interventions/Control_2	Aroma B:Sticker Once
Interventions/Control_3	Odorless target:Sticker Once
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	30 years-old <=
Age-upper limit	59 years-old >=
Gender	Male and Female
Key inclusion criteria	1.Male and female aged 30 to 59 years old at the time of the informed consent 2.No smoking (past smoking experience is acceptable) 3.No aroma use 4.Healthy (No problem in the preliminary inspection) 5.No history of hospitalization / visit within 1 year 6.Have received the health checkup for 2019 and have no problem(Minor abnormalities and follow-up observations are within the standard) 7.BMI value between 18.5 and 30 8.No abnormalities in wrist or back condition (injuries, numbness, paralysis, etc.) 9.No problem with physical condition (electrocardiogram, blood pressure, pulse, body temperature) on the day of the test, and the doctor's interview, and who is considered to be inappropriate to attend the present study by the investigator 10.Applicants who receive a sufficient explanation of the purpose and content of this study, have the ability to consent, have a good understanding, volunteer to participate, and agreed to participate in this study 11.Subjects who can come on the designated inspection day and can be inspected
Key exclusion criteria	1.Subjects who check in the range of 25% from very dislike in the VAS type questionnaire with scent taste (very dislike-very like) 2.Subjects under 30 and over 60 3.Subjects who is currently going to the hospital and are under treatment 4.Subjects with mental disorders 5.Subjects under medication 6.Subjects who are pregnant or possibly pregnant, or lactating 7.Abnormality found in ECG check 8.Subjects who has high blood pressure / low blood pressure (except systolic blood pressure 90-135mmHg) 9.Subjects who has tachycardia (pulse rate over 90 beats / min) 10.Subjects with respiratory, circulatory, otolaryngological diseases (including chronic sinusitis), or orthopedic diseases 11.Subjects who cannot smell the aroma 12.Subjects with smoking habits 13.Subjects who drink a large amount of alcohol every day (1500ml / day for beer, 3go / day for sake, 2go / day for shochu) 14.Subjects who may show allergic symptoms by the test product (or person who have allergic symptoms) 15.Subjects who prefer unscented and subjects who do not like aroma (have aversion to menthol (e.g., scents such as VICKS vaporub) 16.Subjects who use aroma in daily life * Aroma is the use of a diffuser, aroma lamp, etc. take an aromatic bath such as essential oils. 17.Subjects with physical pain which causes problems in daily life 18.Those who cannot walk for more than 10 minutes without resting in everyday walking 19.Subjects who have difficulty going up and down the stairs 20.Subjects who cannot ride a bicycle for more than 20 minutes 21.Subjects who are left-handed 22.Subjects who are participating in other clinical studies 23.Subjects who have problem with the physical condition measurement on the day of the testing or a doctor's interview, and are judged by the investigator to be inappropriate for this study 24.Subjects who are considered to be inappropriate to attend the present study by the investigator
Target sample size	20

Research contact person
Name of lead principal investigator	1st name Yoshihisa Middle name Last name Abe
Organization	FANCL Corporation
Division name	Research Institute
Zip code	244-0806
Address	12-13 Kamishinano, Totuska-ku, Yokohama, Kanagawa, Japan
TEL	045-820-3891
Email	Ay0272@fancl.co.jp

Public contact
Name of contact person	1st name Toshiaki Middle name Last name Imasu
Organization	FANCL Corporation
Division name	Research Institute
Zip code	244-0806
Address	12-13 Kamishinano, Totuska-ku, Yokohama, Kanagawa, Japan
TEL	045-820-3868
Homepage URL
Email	toimasu@fancl.co.jp

Sponsor
Institute	FANCL Corporation
Institute
Department

Funding Source
Organization	FANCL Corporation
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization	Japan

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

IRB Contact (For public release)
Organization	Ueno-Asagao Clinic Ethical Review Committee
Address	6F Kairaku Building 2-7-5 Higashiueno Taito-ku Tokyo 110-0015, JAPAN
Tel	03-6240-1162
Email	jimukyoku@tes-h.co.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	うえのあさがおクリニック

Other administrative information
Date of disclosure of the study information	2020 Year 03 Month 04 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	24
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	2020 Year 01 Month 23 Day
Date of IRB	2020 Year 01 Month 23 Day
Anticipated trial start date	2020 Year 03 Month 04 Day
Last follow-up date	2020 Year 03 Month 06 Day
Date of closure to data entry	2020 Year 03 Month 13 Day
Date trial data considered complete	2020 Year 03 Month 19 Day
Date analysis concluded	2020 Year 03 Month 31 Day

Other
Other related information

Management information
Registered date	2020 Year 03 Month 03 Day
Last modified on	2020 Year 09 Month 02 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000045242