UMIN-CTR Clinical Trial

Basic information
Public title	An evaluation study of change in auto-nervous system by consumption of the food which contain the aroma component of black tea.
Acronym	An evaluation study of change in auto-nervous system by consumption of the food which contain the aroma component of black tea.
Scientific Title	An evaluation study of change in auto-nervous system by consumption of the food which contain the aroma component of black tea.
Scientific Title:Acronym	An evaluation study of change in auto-nervous system by consumption of the food which contain the aroma component of black tea.
Region	Japan

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

Objectives
Narrative objectives1	To verify the influence to auto-nervous system and to sedative action by oral consumption of the food which contain the aroma component of black tea.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	*Evaluation of autonomic nervous system (pupil versus light reflection, skin temperature) * Evaluation of central nervous system (stabilometry, brain stress, NIRS)
Key secondary outcomes	*Multiple mood scale (short version, 40 question) *VAS questionnaire about fragrance and mood * Incidence of adverse events and side effects

Base
Study type	Interventional

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

Intervention
No. of arms	2
Purpose of intervention	Prevention
Type of intervention	Food
Interventions/Control_1	Intake one tablet of test food - Measurement of autonomic nervous system - Intake one tablet of test food - Measurement of central nervous system 1 - Intake one tablet of test food - Measurement of central nervous system 2
Interventions/Control_2	Intake one tablet of control food - Measurement of autonomic nervous system - Intake one tablet of control food - Measurement of central nervous system 1 - Intake one tablet of control food - Measurement of central nervous system 2
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	39 years-old >=
Gender	Female
Key inclusion criteria	(1) Females aged 20 to 39 years old when consent obtain. (2) Females 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) Females who dislike the fragrance of black tea 2) Females who have smoking habit. 3) Females who are cold-sensitive constitution. 4) Females who are receiving medication due to treatment of some disease within current one month before the test. 5) Females who are receiving treatment for pollen allergy within current one month before the test. 6) Females with stuffy nose such as allergic rhinitis or females who can't identify the fragrance. 7) Subjects who have previous and/or current medical history of serious disease in liver, kidney, heart, lung and/or blood. 8) Females with high blood pressure symptoms such as systolic blood pressure of 160 mmHg and more or diastolic blood pressure of 100 mmHg and more. 9) Females who are pregnant or are lactating. 10) Females who have symptom of dermatologic disease such as atopic dermatitis. 11) Females who have undergone surgery on investigation objective portion within the past 6 months. 12) Females who feel pain or discomfort when they bend their knee. 13) Females who are participating the other clinical tests of medicines or foods. Females who participated other clinical tests of medicines or foods within a month prior to the current study. 14) Others who have been determined ineligible by principal investigator or sub-investigator.
Target sample size	30

Research contact person
Name of lead principal investigator	1st name Masayuki Middle name Last name Suzuki
Organization	Mitsui Norin Co., Ltd.
Division name	R&D Group
Zip code	426-0133
Address	223-1 Miyabara, Fujieda-city, Shizuoka-prefecture, 426-0133,JAPAN
TEL	054-648-2600
Email	masayuks@mitsui-norin.co.jp

Public contact
Name of contact person	1st name Masanori Middle name Last name Numa
Organization	CPCC Company Limited
Division name	Planning & Sales Department
Zip code	101-0047
Address	4F Sanwauchikanda Building, 3-3-5 Uchikanda Chiyoda-ku, Tokyo 101-0047, JAPAN
TEL	03-5297-3112
Homepage URL
Email	cpcc-contact@cpcc.co.jp

Sponsor
Institute	CPCC Company Limited
Institute
Department

Funding Source
Organization	Mitsui Norin Co., Ltd
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 Sanwauchikanda Building, 3-3-5 Uchikanda Chiyoda-ku, Tokyo 101-0047, Japan
Tel	03-5297-5548
Email	IRB@cpcc.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

Other administrative information
Date of disclosure of the study information	2020 Year 11 Month 23 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	2019 Year 11 Month 12 Day
Date of IRB	2019 Year 09 Month 20 Day
Anticipated trial start date	2019 Year 11 Month 23 Day
Last follow-up date	2019 Year 11 Month 24 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2019 Year 11 Month 20 Day
Last modified on	2020 Year 11 Month 20 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044037