UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The verification study of improvements in psychological stress with intake of black tea extract supplements: a randomized double-blind placebo-controlled crossover trial
Title of the study (Brief title)	The verification study of improvements in psychological stress with intake of black tea extract supplements
Region	Japan

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

Objectives
Narrative objectives1	To verify study of improvements in psychological stress with intake of extracted Japanese Uva tea supplements
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	autonomic function test 1. low frequency (LF) 2. high frequency (HF) 3. LF/HF 4.autonomic function age subjective symptoms 1. profile of Mood States 2nd edition (POMS2) Japanese version
Key secondary outcomes	1. salivary alpha-amylase activity 2. cortisol activity

Base
Study type	Interventional

Study design
Basic design	Cross-over
Randomization	Randomized
Randomization unit	Individual
Blinding	Double blind -all involved are blinded
Control	Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Food
Interventions/Control_1	Duration: 3 weeks Test material: The powder of extracted Uva tea Dose: Take 4 capsules, three times a day (1 capsule for 200 mg) Administrative: Take 4 capsules before each meal *If you forget to take capsules, take them as soon as you remember
Interventions/Control_2	Duration: 3 weeks Test material: crystalline cellulose and dextrin Dose: Take 4 capsules, three times a day (1 capsule for 200 mg) Administrative: Take 4 capsules before each meal *If you forget to take capsules, take them as soon as you remember
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	Not applicable
Gender	Male and Female
Key inclusion criteria	1. Those who feel stress in daily 2. Healthy Japanese adults 3. Those who are considered to appropriate for the study by the physician 4. Those who have relatively high difference between age of autonomic nervous function and their actual age
Key exclusion criteria	1. Medical history of a malignant tumor, heart failure or myocardial infarction 2. Those who are receiving treatment or having medical history for any of the following chronic diseases: cardiac arrhythmia, hepatic disorder, renal disorder, cerebrovascular disorder, rheumatism, diabetes mellitus, dyslipidemia, hypertension or any other chronic diseases 3. Daily use of Food for Specified Health Uses and/or Foods with Functional Claims 4. Those who currently take medicines (include herbal medicines) and/or supplements 5. Those who are allergic to medicines and/or the test food related products 6. Those who have taken caffeine and have become sick 7. Those who are pregnant, breast-feeding, or are expected to become pregnant during the trial period 8. Another clinical test participant within three months before the informed consent form submission 9. Others assessed as inappropriate for this test by the doctor responsible for the test
Target sample size	20

Research contact person
Name of lead principal investigator	Kazuo YAMAMOTO
Organization	ORTHOMEDICO Inc.
Division name	CEO
Address	2F Sumitomo Fudosan Korakuen Bldg., 1-4-1 Koishikawa, Bunkyo-ku, Tokyo.
TEL	03-3818-0610
Email	kazu@orthomedico.jp

Public contact
Name of contact person	Naoko SUZUKI
Organization	ORTHOMEDICO Inc.
Division name	R&D Department
Address	2F Sumitomo Fudosan Korakuen Bldg., 1-4-1 Koishikawa, Bunkyo-ku, Tokyo.
TEL	03-3818-0610
Homepage URL
Email	nao@orthomedico.jp

Sponsor
Institute	ORTHOMEDICO Inc.
Institute
Department

Funding Source
Organization	ORTHOMEDICO Inc.
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor	Seishin-kai Medical Association Inc, Takara Medical Clinic
Name of secondary funｄer(s)	1. WASEDA University Research Organization for Nano & Life Innovation 2. Mitsui Sugar Co., Ltd.

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	医療法人社団 盛心会 タカラクリニック Seishin-kai Medical Association Inc, Takara Medical Clinic

Other administrative information
Date of disclosure of the study information	2017 Year 09 Month 01 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 11 Month 15 Day
Anticipated trial start date	2017 Year 03 Month 21 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2017 Year 05 Month 30 Day
Last modified on	2017 Year 09 Month 25 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028730