UMIN-CTR Clinical Trial

Unique ID issued by UMIN	UMIN000032773
Receipt number	R000037389
Scientific Title	A verification test of psychological and physiological effects of the aroma of the oils extracted from citrus
Date of disclosure of the study information	2018/05/31
Last modified on	2020/10/09 11:27:25

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Basic information

Public title

A verification test of psychological and physiological effects of the aroma of the oils extracted from citrus

Acronym

A verification test of psychological and physiological effects of the aroma of the oils extracted from citrus

Scientific Title

A verification test of psychological and physiological effects of the aroma of the oils extracted from citrus

Scientific Title:Acronym

A verification test of psychological and physiological effects of the aroma of the oils extracted from citrus

Region

Japan

Condition

Healthy adults

Classification by specialty

Adult

Classification by malignancy

Others

Genomic information

Objectives

Narrative objectives1

By measuring psychological and physiological responses to the aroma of the oils extracted from citrus (orange, iyokan and yuzu), to clarify the functions of those aroma against mind and body.

Basic objectives2

Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Assessment

Primary outcomes

1.Evaluation of autonomic nervous system
2.Evaluation of parasympathetic nervous system

Key secondary outcomes

Base

Study type

Interventional

Study design

Basic design

Cross-over

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

No treatment

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

Intervention

No. of arms

Purpose of intervention

Prevention

Type of intervention

Other

Interventions/Control_1

First term: 5 min rest - measurement - 5 min suction of test sample 1 - measurement (repeat this sequence with five other kind of measurements).
Second term:5 min rest - measurement - 5 min suction of test sample 2 - measurement (repeat this sequence with five other kind of measurements).
Third term:5 min rest - measurement - 5 min suction of test sample 3 - measurement (repeat this sequence with five other kind of measurements).

Interventions/Control_2

First term:5 min rest - measurement - 5 min suction of test sample 2 - measurement (repeat this sequence with five other kind of measurements).
Second term:5 min rest - measurement - 5 min suction of test sample 3 - measurement (repeat this sequence with five other kind of measurements).
Third term:5 min rest - measurement - 5 min suction of test sample 1 - measurement ( repeat this sequence on five other kind of measurements).

Interventions/Control_3

First term:5 min rest - measurement - 5 min suction of test sample 3 - measurement (repeat this sequence with five other kind of measurements).
Second term:5 min rest - measurement - 5 min suction of test sample 1 - measurement (repeat this sequence with five other kind of measurements).
Third term:5 min rest - measurement - 5 min suction of test sample 2 - measurement (repeat this sequence with five other kind of measurements).

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

30 years-old >=

Gender

Male and Female

Key inclusion criteria

1.Males and females aged 20 to 30 years when informed consent.
2.Subjects who aren't bad at the aroma of citrus (orange, iyokan and yuzu).
3.Subjects who show understanding of the clinical study procedures and agreement with participating the study by written informed consent prior to the study.

Key exclusion criteria

1.Subjects who have smoking habit.
2.Subjects who are cold-sensitive constitution. (including subjects like that who feel cold on their hands and foots even in summer)
3.Subjects who are currently receiving medication due to treatment of disease.
4.In a past month, subjects who have had custom of taking or applying medicine for the treatment of diseases.
5.Subjects who have previous and/or current medical history of serious disease in liver, kidney, heart, lung and/or blood.
6.Pregnant or expected pregnant, or lactating women.
7.Subjects who have symptom of dermatologic disease such as atopic dermatitis.
8.Subjects who have undergone surgery on investigation objective portion within the past 6 months.
9.Subjects who are participating the other clinical tests of medicines or foods. Subjects who participated other clinical tests of medicines or foods within a month prior to the current study.
10.Subjects who themselves and/or their family are working for a company that develops and/or manufactures beverage.
11.Other who is determined ineligible by investigator.

Target sample size

Research contact person

Name of lead principal investigator

1st name Motoko

Middle name

Last name Ohata

Organization

NIHON UNIVERSITY

Division name

College of Bioresource Science

Zip code

252-0880

Address

1866 Kameino, Fujisawa-shi, Kanagawa 252-0880 Japan

TEL

0466-84-3987

Email

oohata.motoko@nihon-u.ac.jp

Public contact

Name of contact person

1st name Yukihiro

Middle name

Last name Yada

Organization

University of Tsukuba School of Integrative

Division name

Global Majors

Zip code

305-8577

Address

1-1-1 Tennodai, Tsukuba, Ibaraki 305-8577 Japan

TEL

029-853-7344

Homepage URL

Email

yada.yukihiri.gb@u.tsukuba.ac.jp

Sponsor or person

Institute

NIHON UNIVERSITY

Institute

Department

Personal name

Funding Source

Organization

University of Tsukuba
School of Integrative

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

Institutional Review Board of Chiyoda Paramedical Care Clinic

Address

2F Chusin Building, 3-3-5 Uchikanda Chiyoda-ku, Tokyo 101-0047, JAPAN

Tel

03-5297-5548

Email

IRB@cpcc.co.jp

Secondary IDs

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Other administrative information

Date of disclosure of the study information

2018 Year 05 Month 31 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

2018 Year 05 Month 15 Day

Date of IRB

Anticipated trial start date

2018 Year 06 Month 01 Day

Last follow-up date

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other

Other related information

Management information

Registered date

2018 Year 05 Month 30 Day

Last modified on

2020 Year 10 Month 09 Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037389

Research Plan
Registered date	File name

Research case data specifications
Registered date	File name

Research case data
Registered date	File name