UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000036963
Receipt No. R000042112
Scientific Title An evaluation study of change in auto-nervous system by oral consumption of the food which contain the aroma component of black tea.
Date of disclosure of the study information 2020/06/07
Last modified on 2020/10/09

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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

Condition
Condition Not applicable
Classification by specialty
Not applicable
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To verify the influence to auto-nervous system and to mental state 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 *Pupil versus light reflection
*Skin temperature
*Vascular aging
*Brain executive function
*Brain age
Key secondary outcomes *Multiple mood scale (short version, 40 question)
*VAS questionnaire
* Incidence of adverse events and side effects

Base
Study type Interventional

Study design
Basic design Cross-over
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is 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 Repeat intaking one tablet of test food before test twice (intake 2 tablets of test food in total). Taking gargle. Repeat intaking one tablet of control food before test twice (intake 2 tablets of control food in total).
Interventions/Control_2 Repeat intaking one tablet of control food before test twice (intake 2 tablets of control food in total). Taking gargle. Repeat intaking one tablet of test food before test twice (intake 2 tablets of test food in total).
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) Subjects who themselves and/or their family are working for a company that develops, manufactures or sells health / functional foods and cosmetics.
15) Others who have been determined ineligible by principal investigator or sub-investigator.
Target sample size 24

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 054-639-2600
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 06 Month 07 Day

Related information
URL releasing protocol non-disclosure
Publication of results Unpublished

Result
URL related to results and publications non-disclosure
Number of participants that the trial has enrolled 24
Results non-disclosure
Results date posted
2020 Year 06 Month 09 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics non-disclosure
Participant flow non-disclosure
Adverse events non-disclosure
Outcome measures non-disclosure
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2019 Year 05 Month 17 Day
Date of IRB
2019 Year 05 Month 17 Day
Anticipated trial start date
2019 Year 06 Month 08 Day
Last follow-up date
2019 Year 06 Month 08 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 06 Month 04 Day
Last modified on
2020 Year 10 Month 09 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042112

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.