UMIN-CTR Clinical Trial

Basic information
Public title	Effect of saffron foods for quality of sleep on healthy human
Acronym	Effect of test foods for quality of sleep on healthy human
Scientific Title	Effect of saffron foods for quality of sleep on healthy human
Scientific Title:Acronym	Effect of test foods for quality of sleep on healthy human
Region	Japan

Condition
Condition	healthy adults
Classification by specialty	Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the efficacy of foods containing fermented saffron on reduction in stress and quality of sleep of healthy Japanese
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	sleep electroencephalogram
Key secondary outcomes	OSA questionnaire PSQI questionnaire VAS

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Cluster
Blinding	Double blind -all involved are blinded
Control	Placebo
Stratification	YES
Dynamic allocation	NO
Institution consideration	Institution is not considered as adjustment factor.
Blocking	YES
Concealment	No need to know

Intervention
No. of arms	2
Purpose of intervention	Prevention
Type of intervention	Food
Interventions/Control_1	saffron foods
Interventions/Control_2	Placebo foods
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) Those who are aware of mild sleep disorders, mainly employees of desk work, such as tired, poor sleep, and shallow sleep (2) Those who sleep (turn off) time and wake-up time are regular, sleeping (lights off) time is around 24 o'clock before, and those who have sleeping habits more than 4 hours a day (3) Those working on a 5-day weekly work day during the day and two days off on weekdays (4) Those who sleep alone on bedding (5) Person who obtains consent of voluntary participation in participation by document (6) Person who the doctor responsible for examination (or person responsible for conducting the examination) deems appropriate participation in this examination
Key exclusion criteria	(1) SAS suspected, treated, treated (2) nocturia, benign prostatic hyperplasia, person with overactive bladder, or a person suspected of having it (3) BMIis 25.0 or more (4) Night shift and day shift worker (5) Those who are likely to cause skin irritation due to electrode adhesive pads (such as causing skin inflammation with bandages etc) (6) Those receiving treatment (hormone replacement therapy, medication therapy, exercise therapy, diet therapy, etc.) at a medical institution or the like for treatment or prevention of diseases at the time of acquiring consent, or a condition requiring treatment Those judged (7) Person who has a history of serious diseases or psychiatric diseases of glucose metabolism, lipid metabolism, liver function, renal function, heart, circulatory organ, respiratory organs, endocrine system, immune system, nervous system (8) Persons who have history of alcohol anddrug dependence (9) Persons whose daily alcohol consumption exceeds 60 g / day in terms of average alcohol equivalent per day (10) Persons who have drinking habits more than 4 days a week, or who can not drink alcohol on the day of electroencephalograph insertion (11) Those who are allergic to the test foods, or those who may cause severe allergic symptoms in other foods and medicines (12) Persons who are taking health foods described as "saffron", which is a component involved in this test food (13) Those who participate in other human tests (all tests for humans using cosmetics, foods, medicines, quasi-drugs, medical devices, etc.) within the past 4 weeks, Those who plan to participate in other human examinations during the scheduled period (14) Person who judges that the examination responsible doctor (or person responsible for conducting the examination) is inappropriate for participating in the examination
Target sample size	52

Research contact person
Name of lead principal investigator	1st name Ryuji Middle name Last name Takeda
Organization	Kansai University of welfare Sciences
Division name	Faculty of Health Science for Welfare, Department of Nutritional Sciences for Well-being
Zip code	582-0026
Address	Asahigaoka 3-11-1, Kashiwara
TEL	0729780088
Email	rtakeda@tamateyama.ac.jp

Public contact
Name of contact person	1st name Ryuji Middle name Last name Takeda
Organization	Kansai University of Welfare Sciences
Division name	Faculty of Health Science for Welfare, Department of Nutritional Sciences for Well-being
Zip code	582-0026
Address	Asahigaoka 3-11-1, Kashiwara
TEL	072-978-0088
Homepage URL
Email	rtakeda@tamateyama.ac.jp

Sponsor
Institute	DRC Co., Ltd.
Institute
Department

Funding Source
Organization	Seikatsu Sougou Service 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	Kensyokai institutional review board
Address	Tamagawa 2-12-16, Fkushima-Ku Osaka
Tel	06-6882-1130
Email	ethics_board@drc-web.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 02 Month 14 Day

Related information
URL releasing protocol
Publication of results	Published

Result
URL related to results and publications
Number of participants that the trial has enrolled	52
Results
Results date posted
Results Delayed	Delay expected
Results Delay Reason	in preparation
Date of the first journal publication of results	2020 Year 03 Month 31 Day
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 02 Month 01 Day
Date of IRB	2019 Year 01 Month 31 Day
Anticipated trial start date	2019 Year 02 Month 16 Day
Last follow-up date	2019 Year 03 Month 24 Day
Date of closure to data entry	2019 Year 03 Month 24 Day
Date trial data considered complete	2019 Year 05 Month 01 Day
Date analysis concluded	2019 Year 08 Month 31 Day

Other
Other related information

Management information
Registered date	2019 Year 02 Month 15 Day
Last modified on	2022 Year 07 Month 30 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040824