UMIN-CTR Clinical Trial

Basic information
Public title	Study on sleep-improving effects by test-food intakes
Acronym	Study on sleep-improving effects by test-food intakes
Scientific Title	Study on sleep-improving effects by test-food intakes
Scientific Title:Acronym	Study on sleep-improving effects by test-food intakes
Region	Japan

Condition
Condition	Healthy male/female adults
Classification by specialty	Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To verify sleep-improving effects by test-food intakes for two weeks
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Sleeping condition measured by electroencephalograph (sleep-scope)
Key secondary outcomes	1. Oguri-Shirakawa-Azumi sleep inventory ver. MA 2. MOS 36-Item Short-Form Health Survey version2 (acute version) 3. Cortisol and alpha-amylase in saliva

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	Consumption of the test food to the subjects, two a day for 2 weeks.
Interventions/Control_2	Consumption of the placebo food to the subjects, two a day for 2 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) Healthy male/female subjects with unsatisfactory sleep, ranging in age from 20 to 64 at informed consent. (2) Subjects having the habit of going to bed by 24 o'clock. (3) Subjects taking in a staple food for dinner every day. (4) During the test period, subjects who can take the test foods daily after fifteen o'clock, two a day. (5) Subjects who can receive the test foods twice a week. (6) Subjects who can give informed consent to participate in this study, after being provided with an explanation of the protocol detail.
Key exclusion criteria	Subjects - - (1) taking in sleep-affecting foods, not less than three times a week, (2) who will take medicines which might affect the test (e.g., sleeping pill) during the test period, (3) vaccinated within two weeks before this study, or planning to vaccinate during intaking of test-foods, (4) with not less than 30.0 kg/m2 of BMI, (5) with sleep-apnea syndrome, (6) with previous medical history of sleep disorder, (7) with a continuous medical treatment for sleep disorder, (8) cannot use the sleep-scope during the test period, (9) with an alcohol intake at the measurement of brain waves, (10) with an overnight trip during the test period, (11) with extremely irregular dietary habit/life rhythm, (12) with a serious sleep-affecting rhinitis, (13) with excessive alcohol intake, (14) with the roomer planning to participate in this study, (15) restricting their mealtimes to no more than once a day (not less than once a week), within the last month, (16) with medical history of serious diseases, (17) with pregnancy, possibly one, or lactating, (18) with drug/food allergy (wheat, egg, milk), (19) being fitted with a pacemaker, (20) with sensitive skin, irritating by an adhesive tape, (21) being under another clinical test (medicine or health food), or participated in that within the last 4 weeks, or will join that after the consent, (22) who donated their blood components or blood (0.2 L) within the last month, (23) who donated his blood (0.4 L) within the last 3 months, (24) who donated her blood (0.4 L) within the last 4 months, (25) being collected in total of his blood (1.2 L) within the last 12 months and in this study, (26) being collected in total of her blood (0.8 L) within the last 12 months and in this study, (27) being determined as ineligible for participation by the principal/sub investigator - - .
Target sample size	16

Research contact person
Name of lead principal investigator	1st name Fumiko Middle name Last name Nakamura
Organization	CPCC Company Limited
Division name	Clinical Support Department
Zip code	101-0047
Address	4F Sanwa-Uchi-Kanda Building, 3-3-5 Uchi-Kanda, Chiyoda-ku, Tokyo 101-0047, Japan
TEL	03-5297-3112
Email	cpcc-contact@cpcc.co.jp

Public contact
Name of contact person	1st name Makoto Middle name Last name Ichinohe
Organization	CPCC Company Limited
Division name	Clinical Planning Department
Zip code	101-0047
Address	4F Sanwa-Uchi-Kanda Building, 3-3-5 Uchi-Kanda, 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)

IRB Contact (For public release)
Organization	Institutional Review Board of Chiyoda Paramedical Care Clinic
Address	2F Sanwa-Uchi-Kanda Building, 3-3-5 Uchi-Kanda, 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	2022 Year 10 Month 01 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	2021 Year 09 Month 22 Day
Date of IRB	2021 Year 09 Month 17 Day
Anticipated trial start date	2021 Year 10 Month 01 Day
Last follow-up date	2021 Year 12 Month 11 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2021 Year 09 Month 27 Day
Last modified on	2022 Year 09 Month 26 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051992