UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000051909 |
|---|---|
| Receipt number | R000059207 |
| Scientific Title | Verification study on the effect of the test foods on improvement quality of sleep |
| Date of disclosure of the study information | 2023/08/15 |
| Last modified on | 2023/10/30 18:38:09 |
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Basic information
Public title
Verification study on the effect of the test foods on improvement quality of sleep
Acronym
Verification study on the effect of the test foods on improvement quality of sleep
Scientific Title
Verification study on the effect of the test foods on improvement quality of sleep
Scientific Title:Acronym
Verification study on the effect of the test foods on improvement quality of sleep
Region
| Japan |
Condition
Condition
Not applicable
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this 8-weeks study is to verify the effect of the test foods on improvement quality of sleep in Japanese healthy male/female adults, who are not satisfied with their quality of sleep.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
OSA sleep inventory MA version (OSA-MA),
Visual analogue scale for sleep
Key secondary outcomes
OSA-MA (initiation and maintenance of sleep, frequent dreaming, refreshing, sleep length), AIS, JESS, Electroencephalogram (initiation of sleep, nocturnal awakening, sleep efficiency, REM/non-REM sleep), Fitbit Versa 3 ( snore, noise level, sleep score), The proportion of division and 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 8 weeks
Interventions/Control_2
Daily intake of placebo (control food) for 8 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 male/female who are 20 years of age or older at the time of consent.
(2)Subjects who are not satisfied with their sleep quality.
(3)Those who are able to keep their bed room at their comfortable temperature.
(4)Those 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)Those who are on treatment for a serious illness.
(2)Those who are at late night work, shift work, or heavy work.
(3)Those whose sleep time or sleep habits are irregular on weekdays.
(4)Those who visit the hospital because of mental disorders (depression etc.) or sleep disorders, or who have been diagnosed with mental disorders.
(5)Those who have been diagnosed as Sleep Apnea Syndrome or have subjective symptoms of apnea.
(6)Those 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.
(7)Those who are habitual smokers.
(8)Those who are in the habit of consuming foods that inhibit sleepiness before bedtime or using devices that inhibit sleepiness.
(9)Those who with metal Allergies or sensitive skin.
(10)Those who may be prevented from sleep by others, including preschoolers, care required, one(s) who share bedroom.
(11)Those with food allergies or those who may be allergic to the test food.
(12)Those who regularly use licensed drugs or quasi-drugs that may affect the study.
(13)Those who regularly use health foods that may affect the study.
(14)Those who are participating in a clinical trial or have participated in another clinical trial within 1 months from the date of obtaining consent.
(15)Those who may be unable to maintain their daily lifestyle.
(16)Those who are pregnant or breastfeeding or planning to become pregnant during the study.
(17)Those who plan to participate in any other clinical trial during the study.
(18)Those who are deemed inappropriate for this study by the investigator.
Target sample size
102
Research contact person
Name of lead principal investigator
| 1st name | Shuichi |
| Middle name | |
| Last name | Segawa |
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 | Yuki |
| Middle name | |
| Last name | Kitahara |
Organization
Apoplis 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 | 08 | Month | 15 | 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
No longer recruiting
Date of protocol fixation
| 2023 | Year | 07 | Month | 31 | Day |
Date of IRB
| 2023 | Year | 08 | Month | 14 | Day |
Anticipated trial start date
| 2023 | Year | 08 | Month | 16 | Day |
Last follow-up date
| 2023 | Year | 12 | Month | 31 | 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 | 08 | Month | 15 | Day |
Last modified on
| 2023 | Year | 10 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000059207
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