UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000049060 |
|---|---|
| Receipt number | R000055764 |
| Scientific Title | A Study of the effects of a test-food on sleep-improving |
| Date of disclosure of the study information | 2023/09/29 |
| Last modified on | 2023/08/21 12:23:04 |
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Basic information
Public title
A Study of the effects of a test-food on sleep-improving
Acronym
A Study of the effects of a test-food on sleep-improving
Scientific Title
A Study of the effects of a test-food on sleep-improving
Scientific Title:Acronym
A Study of the effects of a test-food on sleep-improving
Region
| Japan |
Condition
Condition
Healthy male/female adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
In order to validate some kind of effect by the test-food intakes for four weeks on sleep-improving
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Oguri-Shirakawa-Azumi sleep inventory ver.MA
Key secondary outcomes
1. Sleeping condition measured by electroencephalograph (sleep-scope)
2. Vas questionnaire
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
Consumption of the test food, one a day for 2 weeks.
Interventions/Control_2
Consumption of the placebo food, one a day for 2 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
| 65 | years-old | > |
Gender
Male and Female
Key inclusion criteria
(1) Healthy male/female subjects ranging in age from 20 to 64, at informed consent.
(2) Subjects having the habit of going to bed by 24 o'clock.
(3) Subjects taking in a staple food for dinner every day.
(4) During the test period, subjects who can take the test foods daily after fifteen o'clock, two a day.
(5) Subjects who can receive the test foods once a week.
(6) Subjects who can give informed consent, after being provided with an explanation of the protocol detail.
Key exclusion criteria
Subjects-
(1) taking in sleep-affecting foods, not less than three times a week
(2) who will take medicines which might affect the test (e.g., sleeping pill) during the test period
(3) vaccinated within two weeks before this study, or planning to vaccinate during intaking of test-foods
(4) with not less than 30.0 kg/m2 of BMI
(5) with sleep-apnea syndrome
(6) with previous medical history of sleep disorder
(7) with a continuous medical treatment for sleep disorder
(8) cannot use the sleep-scope during the test period
(9) with an alcohol intake at the measurement of brain waves
(10) with an overnight trip during the test period
(11) with extremely irregular dietary habit/life rhythm
(12) with a serious sleep-affecting rhinitis
(13) with excessive alcohol intake
(14) QIDS-J >=11
(15) with the roomer planning to participate in this study
(16) restricting their mealtimes to no more than once a day (not less than once a week), within the last month
(17) with medical history of serious diseases
(18) with pregnancy, possibly one, or lactating
(19) with drug/food allergy (wheat, egg, milk)
(20) being fitted with a pacemaker
(21) with sensitive skin, irritating by an adhesive tape
(22) being under another clinical test (medicine or health food), or participated in that within the last 4 weeks, or will join that after the consent
(23) who donated their blood components or blood (0.2 L) within the last month
(24) who donated his blood (0.4 L) within the last 3 months
(25) who donated her blood (0.4 L) within the last 4 months
(26) being collected in total of his blood (1.2 L) within the last 12 months and in this study
(27) being collected in total of her blood (0.8 L) within the last 12 months and in this study
(28) being determined as ineligible for participation by the principal/sub investigator
Target sample size
40
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 103-0021, 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 103-0021, 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
Nisshin Seifun Group Inc.
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 | 09 | Month | 29 | 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
40
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 | 07 | Month | 20 | Day |
Date of IRB
| 2022 | Year | 07 | Month | 15 | Day |
Anticipated trial start date
| 2022 | Year | 09 | Month | 30 | Day |
Last follow-up date
| 2022 | Year | 12 | 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
| 2022 | Year | 09 | Month | 29 | Day |
Last modified on
| 2023 | Year | 08 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055764
