UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000059263 |
|---|---|
| Receipt number | R000067690 |
| Scientific Title | Evaluation of the Effects of Continued Consumption of the Study Food on Sleep: A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Trial |
| Date of disclosure of the study information | 2025/10/02 |
| Last modified on | 2025/10/01 21:03:39 |
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Basic information
Public title
Evaluation of the Effects of Continued Consumption of the Study Food on Sleep: A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Trial
Acronym
Evaluation of the Effects of Continued Consumption of the Study Food on Sleep
Scientific Title
Evaluation of the Effects of Continued Consumption of the Study Food on Sleep: A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Trial
Scientific Title:Acronym
Evaluation of the Effects of Continued Consumption of the Study Food on Sleep
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To assess the impact of four weeks of test supplement intake on sleep in individuals dissatisfied with their sleep quality.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Change in total score of the Japanese version of the Athens Insomnia Scale (AIS-J) after 4 weeks.
Key secondary outcomes
- Change in AIS-J subscale scores after 4 weeks
- Change in OSA Sleep Inventory MA version scores (sleepiness on waking, sleep initiation and maintenance, dreaming, recovery from fatigue, sleep duration) after 4 weeks
- Change in total score of the Japanese version of the Epworth Sleepiness Scale (J-ESS) after 4 weeks
- Change in POMS2 (Adult Short Version) TMD scores (AH, CB, DD, FI, TA, VA, F) after 4 weeks
- Change in fatigue VAS questionnaire scores after 4 weeks
- Change in Cognitrax Basic work performance scores after 4 weeks
- Change in sleep EEG (SleepScope) evaluation items after 4 weeks
- Change in SPQ (Single-Item Presenteeism Question) scores after 4 weeks
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
Test supplement: 4 tablets per day, taken with water or lukewarm water
Interventions/Control_2
Placebo supplement: 4 tablets per day, taken with water or lukewarm water
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. Age 20 to under 65
2. Japanese men and women
3. Dissatisfied with sleep quality
4. BMI under 30 kg/m^2
5. Able to enter electronic diaries via smartphone or PC
6. Fully informed of the study purpose and content, voluntarily consented in writing
Key exclusion criteria
1. Currently receiving treatment for any disease (including medication or Kampo; as-needed use permitted except for sleep medications), or history of sleep disorders/treatment (including OTC drugs)
2. Under physician-supervised dietary or exercise therapy
3. Current or past serious illness
4. Regular use of OTC drugs, quasi-drugs, specified health foods, supplements, or functional foods (participation allowed if discontinued after consent)
5. Household with infants under 1 year
6. Sleeping with young children (aged 1 to school entry)
7. Living with individuals requiring nursing care
8. Sharing bedding with others
9. Nocturia (urinating 3 or more times per night)
10. Diagnosed with or aware of sleep apnea
11. Unable to wear the EEG device during the study
12. Unable to abstain from alcohol on EEG measurement days
13. Sensitive skin prone to irritation from adhesive tape
14. Overnight travel or business trips during the EEG device period
15. Current or past drug or food allergies
16. Excessive alcohol consumption (more than 40g pure alcohol/day)
17. Heavy smoking (more than 21 cigarettes/day)
18. Shift workers with night shifts
19. Planning major lifestyle changes (diet, sleep, exercise) during study
20. Pregnant, breastfeeding, or planning pregnancy during study
21. Participation in other clinical studies within 1 month before consent, currently, or planned during study
22. Deemed unsuitable for participation by the principal investigator
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | Katsuyuki |
| Middle name | |
| Last name | Shiono |
Organization
Algal Bio Co., Ltd.
Division name
Wellness Group
Zip code
277-0882
Address
Tokatsu Techno Plaza 301, 5-4-6 Kashiwanoha, Kashiwa,Chiba 277-0882, Japan
TEL
04-7138-6207
shiono@algalbio.co.jp
Public contact
Name of contact person
| 1st name | Hirokuni |
| Middle name | |
| Last name | Kayama |
Organization
IMEQRD Co., Ltd.
Division name
Planning and Sales Department
Zip code
104-0061
Address
Daiwa Ginza Bld. 3F, 6-2-1, Ginza, Chuo-ku, Tokyo, Japan
TEL
0367045968
Homepage URL
clinical-trial@imeqrd.co.jp
Sponsor or person
Institute
IMEQRD Co. Ltd.
Institute
Department
Personal name
Funding Source
Organization
Algal Bio 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
Suda Clinic institutional review board
Address
2-8-14,Takadanobaba,Shinjyuku,Tokyo
Tel
0367045968
jimukyoku@imeqrd.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
| 2025 | Year | 10 | Month | 02 | 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
Preinitiation
Date of protocol fixation
| 2025 | Year | 08 | Month | 18 | Day |
Date of IRB
| 2025 | Year | 09 | Month | 16 | Day |
Anticipated trial start date
| 2025 | Year | 10 | Month | 03 | Day |
Last follow-up date
| 2025 | Year | 12 | Month | 20 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2025 | Year | 10 | Month | 01 | Day |
Last modified on
| 2025 | Year | 10 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067690
