UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A study on the effectiveness of SRRA001(development code)
Title of the study (Brief title)	A study on the effectiveness of SRRA001(development code)
Region	Japan

Condition
Condition	Healthy individuals with relatively-deteriorated sleep health
Classification by specialty	Psychiatry Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To confirm the effectiveness of SRRA001(development code) for improvement of sleep quality
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Subjective and objective indicators on sleep quality before and after the intake of test foods for 8 days
Key secondary outcomes	Autonomic nervous activity, physical activity and biochemical components in blood and saliva before and after the intake of test foods for 8 days

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	SRRA001(development code) ingestion (Once a day for 8 days, before sleep onset) (Wash out for 3 weeks) Placebo ingestion (Once a day for 8 days, before sleep onset)
Interventions/Control_2	Placebo ingestion (Once a day for 8 days, before sleep onset) (Wash out for 3 weeks) SRRA001(development code) ingestion (Once a day for 8 days, before sleep onset)
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	59 years-old >=
Gender	Male
Key inclusion criteria	1.Healthy male, age >=20 and <=59 years 2.Individuals whose PSQI score is higher than average score.
Key exclusion criteria	1.Individuals attending a hospital or using medical products 2.Individuals using medical products for pollinosis 3.Individuals who have chronic illness 4.Individuals who have a history of serious disease (heart disease, kidney damage, diabetes, cancer, and so on) 5.Individuals who are sensitive to medical tapes or electrodes 6.Individuals who participate in the other examinations which have an influence on this examination 7.Individuals judged inappropriate for the study by the principal
Target sample size	32

Research contact person
Name of lead principal investigator	Takatoshi Murase
Organization	Kao Corporation
Division name	R&D -Core Technology- Biological Science Research
Address	2606, Akabane, Ichikai-machi, haga-gun, Tochigi, 321-3497, JAPAN
TEL	0285-68-7871
Email	murase.takatoshi@kao.co.jp

Public contact
Name of contact person	Yasunori Yamamoto
Organization	Kao Corporation
Division name	R&D -Core Technology- Biological Science Research
Address	2606, Akabane, Ichikai-machi, haga-gun, Tochigi, 321-3497, JAPAN
TEL	0285-68-7468
Homepage URL
Email	yamamoto.yasunori@kao.co.jp

Sponsor
Institute	Kao Corporation
Institute
Department

Funding Source
Organization	Kao Corporation
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization

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

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	花王株式会社（栃木県）

Other administrative information
Date of disclosure of the study information	2017 Year 02 Month 06 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2017 Year 01 Month 25 Day
Anticipated trial start date	2017 Year 02 Month 10 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 02 Month 03 Day
Last modified on	2018 Year 01 Month 29 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029886