UMIN-CTR Clinical Trial

Basic information
Public title	A confirmation test of the influence for sleep, stress and feeling of fatigue, caused by test food consumption
Acronym	A confirmation test of the influence for sleep, stress and feeling of fatigue, caused by test food consumption
Scientific Title	A confirmation test of the influence for sleep, stress and feeling of fatigue, caused by test food consumption
Scientific Title:Acronym	A confirmation test of the influence for sleep, stress and feeling of fatigue, caused by test food consumption
Region	Japan

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

Objectives
Narrative objectives1	Confirm the influence for sleep, stress and feeling of fatigue caused by two weeks consumption of test food.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Condition of sleep, stress and fatigue, assessed by electroencephalography, OSA sleep inventory, VAS questionnaire for feeling of fatigue, POMS2 short version or St. Mary's hospital sleep questionnaire
Key secondary outcomes	Incidence rate of adverse events and side effects

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	Prevention
Type of intervention	Food
Interventions/Control_1	Intake test food for two weeks. Rest for two weeks. Intake control food for two weeks.
Interventions/Control_2	Intake control food for two weeks. Rest for two weeks. Intake test food for two weeks.
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 20 to 64 years old and who are dissatisfied their sleep. 2. Subjects who have a custom of going bed before 24 o'clock 3. Subjects their score of Athens Insomnia Scale are between 6 and 9. 4. Subjects who receive enough explain of the test, who deeply understanding of the test, and who obtain own consent to participate the test.
Key exclusion criteria	Subjects who 1.are given continuous treatment by taking medicines. 2.constantly use oral medicines having a possibility of affecting test results. 3.constantly use food having a possibility of affecting test results, such as food for specific health use. 4.have current and/or previous medical history of serious disease. 5.have current and/or previous medical history of sleep disorder. 6.self-aware about their sleep apnea. 7.awake during sleep more than two times a week due to night urination. 8.have allergic rhinitis. 9.use pacemaker. 10.have previous medical history of allergy for medicine and/or food. 11.those BMI are over 30 kg/m2. 12.tend to have skin rash with adhesive tape due to skin hypersensitivity. 13.are pregnant or lactating. 14.have extremely irregular dining and life habits. 15.excessive alcohol intake. 16.are not be able to avoid alcohol intake during test period. 17.are not be able to use electroencephalograph during test period. 18.have plan lodging by travel and/or business trip. 19.are participating the other clinical tests, participated within 4-weeks prior to the current study and/or plan to participate the other clinical tests. 20.donated over 200mL blood and/or blood components within the last one month. And 21.Males who donated over 400mL blood and/or blood components within the last three month. 22.Females who donated over 400mL blood and/or blood components within the last four month. 23.Males who will be collected over 1200mL blood and/or blood components, when the sampling amounts within the last twelve month are adding to the planned sampling amounts of this study. 24.Females who will be collected over 800mL blood and/or blood components when, the sampling amounts within the last twelve month are adding to the planned sampling amounts of this study. 25.Others who have been determined ineligible by principal investigator or sub-investigator.
Target sample size	25

Research contact person
Name of lead principal investigator	1st name Kazuhiko Middle name Last name Kawaguchi
Organization	Nippon Chemiphar Co., Ltd.
Division name	Medical Affairs Department
Zip code	101-0032
Address	2-2-3, Iwamoto-cho, Chiyoda-ku, Tokyo 101-0032, Japan
TEL	03-3863-1211
Email	kazuhiko-kawaguchi@chemiphar.co.jp

Public contact
Name of contact person	1st name Makoto Middle name Last name Ichinohe
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	Nippon Chemiphar 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 09 Month 04 Day

Related information
URL releasing protocol
Publication of results	Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Completed
Date of protocol fixation	2019 Year 08 Month 19 Day
Date of IRB	2019 Year 08 Month 16 Day
Anticipated trial start date	2019 Year 09 Month 05 Day
Last follow-up date	2019 Year 11 Month 09 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 09 Month 02 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=R000043197