UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Effect of ingestion of trial supplement on sleep. A randomized, placebo controlled, double blind, cross-over study
Title of the study (Brief title)	Effect of ingestion of trial supplement on sleep
Region	Japan

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

Objectives
Narrative objectives1	This study is aimed to verify improvement effect of trial supplement on sleep using subjective and objective methods.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2
Developmental phase	Not applicable

Assessment
Primary outcomes	OSA sleep inventory MA version
Key secondary outcomes	Sleep electroencephalogram, POMS 2 brief form, visual analogue scale (VAS) for fatigue, VAS for daytime sleepiness

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	NO
Dynamic allocation	NO
Institution consideration	Institution is not considered as adjustment factor.
Blocking	NO
Concealment	No need to know

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Food
Interventions/Control_1	Trial supplement (4 days) - washout period - placebo (4 days)
Interventions/Control_2	Placebo (4 days) - washout period - trial supplement (4 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	20 years-old <=
Age-upper limit	65 years-old >
Gender	Male and Female
Key inclusion criteria	1) Japanese males and females aged from 20 to less than 65 years old. 2) Subjects who are weekday workers 3) Global score of Pittsburgh Sleep Quality Index-Japanese version is more than 6. 4)Subjects who can understand the detail of this study and decide to attend the study.
Key exclusion criteria	1) Subjects who are routinely use the health food, dietary supplement, and medicine including over-the-counter drug for improving of sleep or fatigue. 2) Subjects with excessive alcohol-drinking behaviors. 3) Subjects who cannot stop drinking alcohol during study period I and II 4) Subjects who are under the medication, counseling, or exercise therapy. 5) Subjects who have under treatment or history of disease such as diabetes, liver disease, kidney disease, heart disease, adrenal cortex disease. 6) Subjects who have under treatment or a history of sleep apnea syndrome or is suspected of sleep apnea syndrome. 7) Night and day shift worker or manual laborer 8) Working days and holidays are irregular 9) Subjects who have mental illness or insomnia. 10) Subjects who will use medicine for Perennial allergic rhinitis in study period. 11) Heavy smoker 12) Subjects having possibilities for emerging allergy related to the study foods. 13) Subjects who are planned to become pregnant after informed consent for the current study or are pregnant or lactating. 14) Subjects who have heavy menstrual cramps and premenstrual syndrome. 15) Subjects who are planned to participate in other clinical study 16) Subjects who are judged as unsuitable for the study by the investigator for other reason
Target sample size	60

Research contact person
Name of lead principal investigator	Yoshitaka Iwama
Organization	Nihonbashi Cardiology Clinic
Division name	Director
Address	13-4 Kodenma-cho, Chuo-ku, Tokyo, Japan
TEL	03-5641-4133
Email	yiwama@well-sleep.jp

Public contact
Name of contact person	Eiji Yoshikawa
Organization	KSO Corporation
Division name	Sales department
Address	1-9-7 Shibaura, Minato-ku, Tokyo, Japan
TEL	03-3452-7733
Homepage URL
Email	yoshikawa@kso.co.jp

Sponsor
Institute	KSO Corporation
Institute
Department

Funding Source
Organization	FANCL Corporation
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization	Japan

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	医療法人財団健康睡眠会　日本橋循環器科クリニック

Other administrative information
Date of disclosure of the study information	2016 Year 04 Month 28 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 04 Month 18 Day
Anticipated trial start date	2016 Year 05 Month 29 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	2016 Year 04 Month 26 Day
Last modified on	2016 Year 10 Month 26 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025425