UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Evaluation of sleep-improving effects of a food
Title of the study (Brief title)	Evaluation of sleep-improving effects of a food
Region	Japan

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

Objectives
Narrative objectives1	This study examines sleep-improving effects of a food containing onion extract.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Electroencephalographic(During 5 day intake), St. Mary's Hospital Sleep Questionnaire(During 5 day intake)
Key secondary outcomes	Salivary amylase(Day before the start,1 day,5 day, 6day), Sleep diary(From the first day of ingestion of a test food to the last day of the test)

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	Oral ingestion of the test food containing onion extract (3 pills/day;5 days), wash out period (2 days), Oral ingestion of the test food not containing onion extract (3 pills/day;5 days).
Interventions/Control_2	Oral ingestion of the test food not containing onion extract (3 pills/day;5 days), wash out period (2 days), Oral ingestion of the test food containing onion extract (3 pills/day;5 days).
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	30 years-old <=
Age-upper limit	50 years-old >
Gender	Male and Female
Key inclusion criteria	(1)Male and female who don't feel like a good sleep aged 30 to 49 when consent acquisition. (2)Subjects who have a habit of going to bed before 0 a.m. (3)Subjects whose Pittsburgh Sleep Quality Index score is over 6. (4)Subjects who understand the study procedure and agree to participate in the study by giving informed consent prior to the study.
Key exclusion criteria	(1)Subjects using medical products. (2)Subjects who have a habit of ingestion medicine, health-promoting foods, foods for specified health uses, health foods that may involve this study. (3)Subjects who have a history of heart failure,liver failure, kidney failure,digestive system disease. (4)Subjects whose hay fever is under treatment. (5)Subjects who use pacemaker. (6)Subjects whose skin is sensitive and develop a rash by adhesive bandage. (7)Females who are pregnant or lactating, or who could become pregnant or lactating during test period. (8)Subjects who excessively take alcohol. (9)Subjects whose eating habits and rhythm of daily life are irregular (Shifts workers, late-night workers). (10)Subjects who have a habit of taking onion over 200g/day. (11)Subjects who have allergy for medicine and foods. (12)Subjects whose BMI is over 30. (13)Subjects who are diagnosed with Sleep apnea syndrome, who are aware of being apena during sleep. (14)Subjects who cannot use Sleep Scope during the test period. (15)Subjects who plan to go on a trip with lodging during the test period. (16)Subjects who cannot give up drinking alcohol during the test period. (17)Subjects who have a history of sleep disorder. (18)Subjects using medical products for sleep disorder. (19)Subjects who plan to participate in other clinical tests. (20)Subjects who are not eligible for this study for some medical reasons.
Target sample size	30

Research contact person
Name of lead principal investigator	Fujiwara Suguru
Organization	CPCC Company Limited
Division name	Clinical Research Planning Department
Address	4F Chusin Building, 3-3-5 Uchikanda Chiyoda-ku, Tokyo 101-0047, JAPAN
TEL	03-5297-3112
Email	cpcc-contact@cpcc.co.jp

Public contact
Name of contact person	Makoto Ichinohe
Organization	CPCC Company Limited
Division name	Plan Sales Department
Address	4F Chusin 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	Nisshin Seifun Group Inc.
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

Other administrative information
Date of disclosure of the study information	2018 Year 02 Month 03 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2018 Year 01 Month 17 Day
Anticipated trial start date	2018 Year 02 Month 03 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete	2018 Year 06 Month 29 Day
Date analysis concluded

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

Management information
Registered date	2018 Year 02 Month 02 Day
Last modified on	2018 Year 08 Month 09 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000035544