UMIN-CTR Clinical Trial

Basic information
Public title	A clinical study to evaluate the effects of the test food on improving quality of sleep.
Acronym	A clinical study to evaluate the effects of the test food on improving quality of sleep.
Scientific Title	A clinical study to evaluate the effects of the test food on improving quality of sleep.
Scientific Title:Acronym	A clinical study to evaluate the effects of the test food on improving quality of sleep.
Region	Japan

Condition
Condition	Healthy volunteers
Classification by specialty	Not applicable Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To examine the effects of the food which contains imidazole dipeptide and crocetin on improving quality of sleep
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	electroencephalogram during sleep
Key secondary outcomes	activity tracker, OSA sleep inventory MA version, St. Mary's Hospital Sleep Questionnaire, Japanese version of Karolinska Sleepiness Scale, VAS, autonomic nervous function evaluation, work performance evaluation and urinalysis

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 of test food for 4 weeks -> Washout period ( 4 week) -> Intake of placebo for 4 weeks
Interventions/Control_2	Intake of placebo for 4 weeks -> Washout period ( 4 week) -> Intake of test food for 4 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) Males and females whose age of 20 years or more and less than 65 years 2) Subjects who are aware of impaired sleep quality 3) Subjects receiving a sufficient briefing of the objective and content of the present study, fully understanding and agreeing to voluntarily participate in the study and being able to personally sign a written informed consent
Key exclusion criteria	1) Subjects receiving a medical treatment for sleep disorders 2) Subjects receiving a medical treatment for serious cardio-vascular, hepatic, renal, respiratory, endocrine or metabolic disorders or having a medical history of these disorders 3) Subjects receiving a medical treatment for chronic diseases such as diabetes, hypertension and dyslipidemia 4) Subjects who take regularly pharmaceuticals, quasi-drugs, supplements or health foods which have an influence on study 5) Subjects who have the possibility of developing allergic symptoms by the test food 6) Subjects who live with their infants less than 1 year old 7) Subjects who sleep with others in a bedroom 8) Subjects whose lifestyles are irregular because of night shift or others 9) Subjects who wake up for urination 2 times or more during nocturnal sleep 10) Subjects who drink a lot (Subjects whose pure alcohol intake per day is 60 g or more) 11) Subjects whose body mass index (BMI) is 25 kg/m2 or more 12) Subjects having blood sample of 200 ml or more taken within 1 month, or 400 ml or more within 3 months prior to the start of the present study (e.g. donated blood) 13) Subjects who took part in another clinical study within 3 months prior to the start of the present study or who is currently taking part in another clinical study 14) Female subjects who are pregnant or lactating, or intending to become pregnant during the study 15) Subjects deemed unsuitable by the investigator
Target sample size	36

Research contact person
Name of lead principal investigator	1st name Tadakazu Middle name Last name Takigami
Organization	Japan Preventive Medicine Inc.
Division name	Product Development Department
Zip code	5600082
Address	Senri Life Science Center 14F, 1-4-2, Shinsenri-higashimachi, Toyonaka, Osaka
TEL	06-6831-3383
Email	takigami_tadakazu@soiken.com

Public contact
Name of contact person	1st name Tadakazu Middle name Last name Takigami
Organization	Japan Preventive Medicine Inc.
Division name	Product Development Department
Zip code	5600082
Address	Senri Life Science Center 14F, 1-4-2, Shinsenri-higashimachi, Toyonaka, Osaka
TEL	06-6831-3383
Homepage URL
Email	takigami_tadakazu@soiken.com

Sponsor
Institute	Japan Preventive Medicine Inc.
Institute
Department

Funding Source
Organization	Japan Preventive Medicine 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	IRB of Fukuda Clinic
Address	Shin-Osaka brick building 2F, 1-6- 1 Miyahara, Yodogawa, Osaka, Os aka
Tel	06-6398-0203
Email	fukudaclinicIRB@gmail.com

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	2021 Year 05 Month 23 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 12 Month 21 Day
Date of IRB	2020 Year 02 Month 15 Day
Anticipated trial start date	2020 Year 02 Month 22 Day
Last follow-up date	2020 Year 05 Month 23 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2020 Year 01 Month 24 Day
Last modified on	2022 Year 07 Month 26 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000044750