UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000035882 |
|---|---|
| Receipt number | R000040824 |
| Scientific Title | Effect of saffron foods for quality of sleep on healthy human |
| Date of disclosure of the study information | 2020/02/14 |
| Last modified on | 2022/07/30 22:54:38 |
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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
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
rtakeda@tamateyama.ac.jp
Sponsor or person
Institute
DRC Co., Ltd.
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040824
| Research Plan | |
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| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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