UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000046247 |
|---|---|
| Receipt number | R000052777 |
| Scientific Title | Evaluation of the effects on sleep quality and fatigue the next day after eating the test meal |
| Date of disclosure of the study information | 2022/12/30 |
| Last modified on | 2023/04/10 11:21:47 |
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Basic information
Public title
Evaluation of the effects on sleep quality and fatigue the next day after eating the test meal
Acronym
Evaluation of the effects on sleep quality and fatigue the next day after eating the test meal
Scientific Title
Evaluation of the effects on sleep quality and fatigue the next day after eating the test meal
Scientific Title:Acronym
Evaluation of the effects on sleep quality and fatigue the next day after eating the test meal
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the effects of sleep quality and fatigue the next day from continued intake of test foods.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
To Evaluate of subjective sleep(OSA sleep inventory MA version, Pittsburgh Sleep Quality Index (PSQI), VAS), autonomic function test(LF,HF,LF/HF,TP), IL-6 in serum, VAS on fatigue
Key secondary outcomes
Profile of Mood States 2nd Edition, Cognitive function evaluation(Stroop Test, Shifting Attention, Continuous Performance, Four Part Continuous Performance)
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
Treatment
Type of intervention
| Food |
Interventions/Control_1
Intake of test foods for 4 weeks before going to bed.
Interventions/Control_2
Intake of placebo foods for 4 weeks before going to bed.
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
| 60 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
(1)Japanese men and women whose age at the time of obtaining consent is 20 to 59 years old
(2)Subjects who are dissatisfied with sleep (trouble with sleep, waking up in the middle of the night , poor sleep, daytime sleepiness)
(3)Subjects whose Pittsburgh Sleep Quality Index(PSQI) score is over 6 points
Key exclusion criteria
(1) Subjects who are currently receiving drug treatment due to some kind of illness
(2) Subjects with a history of serious illnesses with digestive organs, liver, kidneys, heart, lungs, blood, etc.
(3)Subjects who may have allergic reactions due to the ingredients of the test product
(4) Subjects who are pregnant or may be pregnant, and those who are breastfeeding
(5) Subjects whose lifestyle may change during the examination period (night shift, long trip, work transfer, etc.)
(6) Subjects with sleep apnea
(7)Subjects with severe allergies
(8) Subjects with arrhythmia
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Yasuaki |
| Middle name | |
| Last name | Nakanishi |
Organization
EZAKI GLICO Co., Ltd
Division name
R&D LABORATORY
Zip code
555-8502
Address
4-6-5, Utajima, NIshiyodogawa-ku, Osaka
TEL
06-6477-8793
yasuaki.nakanishi@glico.com
Public contact
Name of contact person
| 1st name | Masaki |
| Middle name | |
| Last name | Furuya |
Organization
EZAKI GLICO Co., Ltd
Division name
R&D LABORATORY
Zip code
555-8502
Address
4-6-5, Utajima, NIshiyodogawa-ku, Osaka
TEL
06-6477-8793
Homepage URL
yasuaki.nakanishi@glico.com
Sponsor or person
Institute
EZAKI GLICO Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
EZAKI GLICO 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
The Institutional Review Board of Glico Group
Address
4-6-5 Utajima, Nishiyodogawa-ku, Osaka 555-8502, Japan
Tel
05017454027
toshihiko.koike@glico.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
| 2022 | Year | 12 | Month | 30 | 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
| 2021 | Year | 11 | Month | 09 | Day |
Date of IRB
| 2021 | Year | 11 | Month | 09 | Day |
Anticipated trial start date
| 2022 | Year | 01 | Month | 11 | Day |
Last follow-up date
| 2022 | Year | 04 | Month | 10 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2021 | Year | 12 | Month | 01 | Day |
Last modified on
| 2023 | Year | 04 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052777
