UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000050007 |
|---|---|
| Receipt number | R000056957 |
| Scientific Title | Verification study on the effects of intake of test foods on the improvement quality of sleep |
| Date of disclosure of the study information | 2023/01/13 |
| Last modified on | 2023/10/05 14:41:51 |
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Basic information
Public title
Verification study on the effects of intake of test foods on the improvement quality of sleep
Acronym
Verification study on the effects of intake of test foods on the improvement quality of sleep
Scientific Title
Verification study on the effects of intake of test foods on the improvement quality of sleep
Scientific Title:Acronym
Verification study on the effects of intake of test foods on the improvement quality of sleep
Region
| Japan |
Condition
Condition
Not applicable
Classification by specialty
| Not applicable |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to verify the effect of intake of test foods on improvement quality of sleep by Japanese healthy subjects over 20 years of age consume it for 4 weeks.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Check for "Sleepiness on rising" in the OSA sleep inventory MA version (OSA-MA)
Key secondary outcomes
"Initiation and maintenance of sleep" , "frequent dreaming", "refreshing", "sleep length" in the OSA-MA, PSQI, JESS, The sleep scope (Electroencephalogram (Initiation of sleep, Nocturnal awakening, Sleep efficiency), Sleep stage(REM/non-REM sleep)), The proportion of division or family of intestinal bacteria
Base
Study type
Interventional
Study design
Basic design
Parallel
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
Daily intake of test food for 4 weeks
Interventions/Control_2
Daily intake of placebo (control 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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
(1) Healthy Japanese men and women who are 20 years of age or older at the time of consent.
(2) Subjects who are concerned about their sleep quality.
(3) Persons who have signed a consent form prior to the start of the study upon full explanation of the purpose and content of the study.
Key exclusion criteria
(1) Persons who are on treatment for a serious illness.
(2) Persons whose sleep time or sleep habits are irregular because of night shift etc.
(3) Persons who visit the hospital because of mental disorders (depression etc.) or sleep disorders, or were diagnosed with mental disorders at once.
(4) Persons who are diagnosed Sleep Apnea Syndrome or have subjective symptoms of apnea.
(5) Subjects who select "I would like to kill myself." or "I would kill myself if I had the chance." at question 9 of Beck Depression Inventory-II (BDI2) at the screening test.
(6) Habitual Smokers.
(7) Persons who have metal Allergy or sensitive skin.
(8) Persons who may be prevented from sound sleep by the other, for instance, who have preschoolers, who nurse care, who sleep on the bed two or more.
(9) Persons with food allergies or those who may be allergic to the test food.
(10) Persons who regularly use licensed drugs or quasi-drugs that may affect the study.
(11) Persons who regularly use health foods that may affect the study.
(12) Persons who are participating in a clinical trial or have participated in another clinical trial within 3 months from the date of obtaining consent.
(13) Persons unable to maintain daily routines.
(14) Pregnant, lactating, or wishing to become pregnant.
(15) Persons who plan to participate in other examinations during the study.
(16) Other subjects who are deemed inappropriate for this study by the investigator.
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Segawa |
| Middle name | |
| Last name | Shuichi |
Organization
Nissin York Co., Ltd.
Division name
Development Laboratories
Zip code
348-8549
Address
272, Tsutsumine, Kamimurakimi, Hanyu-shi, Saitama, Japan
TEL
048-565-4686
shuichi.segawa@nissin.com
Public contact
Name of contact person
| 1st name | Yoshimura |
| Middle name | |
| Last name | Hiroki |
Organization
Apoplus Station Co.,Ltd.
Division name
CRO Department Clinical Operations Division
Zip code
103-0027
Address
2-14-1,Nihonbashi,Chuo-ku,Tokyo 103-0027, JAPAN
TEL
03-6386-8809
Homepage URL
food-contact@apoplus.co.jp
Sponsor or person
Institute
APO PLUS STATION CO., LTD.
Institute
Department
Personal name
Funding Source
Organization
NISSIN YORK 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
Ethics Review Committee of Watanabe Hospital
Address
1-5-6, Haneda, Ota-ku, Tokyo, JAPAN
Tel
03-3741-0223
food-contact@apoplus.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
医療法人社団 渡辺病院(Watanabe Hospital)
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 01 | Month | 13 | 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
| 2022 | Year | 12 | Month | 08 | Day |
Date of IRB
| 2022 | Year | 12 | Month | 24 | Day |
Anticipated trial start date
| 2023 | Year | 01 | Month | 13 | Day |
Last follow-up date
| 2023 | Year | 04 | Month | 03 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2023 | Year | 01 | Month | 11 | Day |
Last modified on
| 2023 | Year | 10 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000056957
