UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000053099 |
|---|---|
| Receipt number | R000060229 |
| Scientific Title | The Effect of a Study Food Product on Sleep |
| Date of disclosure of the study information | 2023/12/14 |
| Last modified on | 2024/08/02 20:31:50 |
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Basic information
Public title
The Effect of a Study Food Product on Sleep
Acronym
The Effect of a Study Food Product on Sleep
Scientific Title
The Effect of a Study Food Product on Sleep
Scientific Title:Acronym
The Effect of a Study Food Product on Sleep
Region
| Japan |
Condition
Condition
Male/female adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To verify the effects on sleep of continuous consumption of the test food product over a period of 4 weeks, compared to the consumption of a placebo food product.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Oguri-Shirakawa-Azumi Sleep Inventory, Middle-age and Aged version
Key secondary outcomes
Pittsburgh Sleep Quality Index (PSQI)
Four-item subjective sensation Likert scale
Objective activity levels (sleep)
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
Consumption of the test food (1 capsule a day) for 4 weeks
Interventions/Control_2
Consumption of the placebo food (1 capsule a day) 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
| 30 | years-old | <= |
Age-upper limit
| 60 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1. Japanese males and females aged 30 to below 60 years at the time of consent acquisition.
2. Subjects experiencing one or more of the following sleep issues: difficulty falling asleep, waking up during the night, or feeling unrefreshed upon waking in the morning.
3. Members of the health advice application.
4. Subjects who can use an activity tracker during the study period.
5. Subjects who can give informed consent to partake in this study, after being provided with an explanation of the protocol detail.
Key exclusion criteria
1. Subjects who regularly consume products advertised for improving sleep, stress, and fatigue more than three times a week and cannot discontinue them from the time of consent acquisition.
2. Subjects taking medications or quasi-drugs (such as sleep aids or nutritional drinks) that may affect the study more than once a week and cannot restrict their use during the study period.
3. Subjects engaging in activities aimed at improving sleep, stress, and fatigue (such as regular medical visits, treatments, or counseling).
4. Subjects who have significant lifestyle changes planned during the study period, such as job changes, moving, or travel lasting more than one week.
5. Perimenopausal women experiencing significant changes in physical condition.
6. Subjects who find it difficult to wear an activity tracker while sleeping.
7. Subjects receiving treatment, medication, or lifestyle guidance for mental disorders, sleep disorders, or chronic fatigue syndrome.
8. Subjects who smoke heavily (not less than 21 cigarettes a day)
9. Subjects who consistently consume alcohol in amounts exceeding moderate drinking (approximately 20 g of pure alcohol per day).
10. Subjects with extremely irregular lifestyle habits.
11. Subjects who are participating the other clinical tests. Subjects who participated within 4-weeks prior to the current study and/or who plan to participate the other clinical tests.
12. Subjects with previous and/or current medical history of serious diseases in heart, liver, kidney and/or digestive organs.
13. Females who are pregnant or lactating, and females who could become pregnant or lactating during test period.
14. Subjects with allergies to medications and/or food.
15. Subjects deemed unsuitable for participation in the trial by the principal investigator.
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | Fumiko |
| Middle name | |
| Last name | Nakamura |
Organization
CPCC Company Limited
Division name
Clinical Support Department
Zip code
103-0021
Address
4F Daiwa Building, 3-3-10 Nihonbashi-Hongoku-Cho, Chuo-ku, Tokyo, Japan
TEL
03-6225-9001
cpcc-contact@cpcc.co.jp
Public contact
Name of contact person
| 1st name | Makoto |
| Middle name | |
| Last name | Ichinohe |
Organization
CPCC Company Limited
Division name
Clinical Planning Department
Zip code
103-0021
Address
4F Daiwa Building, 3-3-10 Nihonbashi-Hongoku-Cho, Chuo-ku, Tokyo, Japan
TEL
03-6225-9001
Homepage URL
cpcc-contact@cpcc.co.jp
Sponsor or person
Institute
CPCC Company Limited
Institute
Department
Personal name
Funding Source
Organization
Meiji 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
Institutional Review Board of Chiyoda Paramedical Care Clinic
Address
2F Daiwa Building, 3-3-10 Nihonbashi-Hongoku-Cho, Chuo-ku, Tokyo 103-0021, Japan
Tel
03-6225-9005
IRB@cpcc.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
| 2023 | Year | 12 | Month | 14 | 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
| 2023 | Year | 11 | Month | 20 | Day |
Date of IRB
| 2023 | Year | 11 | Month | 17 | Day |
Anticipated trial start date
| 2023 | Year | 12 | Month | 15 | Day |
Last follow-up date
| 2024 | Year | 04 | Month | 05 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Name of lead principal investigator: Toshinari Watanabe
Organization: Link and Communication Inc.,
Division name: CEO
Zip code: 103-0021
Address: 5F Shin-Kioicho Building, 4-1 Kioi-Cho, Chiyoda-ku, Tokyo, Japan
TEL: 03-5210-2721
E-mail: research_s@linkncom.co.jp
Management information
Registered date
| 2023 | Year | 12 | Month | 14 | Day |
Last modified on
| 2024 | Year | 08 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000060229
