UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000050446 |
|---|---|
| Receipt number | R000057313 |
| Scientific Title | Validation study on sleep-improvement effects by test-food intakes |
| Date of disclosure of the study information | 2023/03/06 |
| Last modified on | 2024/01/21 18:28:14 |
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Basic information
Public title
Validation study on sleep-improvement effects by test-food intakes
Acronym
Validation study on sleep-improvement effects by test-food intakes
Scientific Title
Validation study on sleep-improvement effects by test-food intakes
Scientific Title:Acronym
Validation study on sleep-improvement effects by test-food intakes
Region
| Japan |
Condition
Condition
Healthy male/female subjects
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
In order to verify improvement effects on sleep by test-food intakes
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Sleep qualities (brain-wave measurement, Oguri-Shirakawa-Azumi sleep inventory ver. MA)
Key secondary outcomes
1. Pittsburgh sleep quality index
2. Epworth sleepiness scale
3. Visual Analogue Scale (fatigue feeling)
4. Visual Analogue Scale (sleep)
5. Amylase in saliva
6. Growth hormone in blood
7. Insulin-like Growth Factor-1 in blood
8. The Profile of Mood States second edition (short ver.)
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 (once a day, 4 capsules each).
Interventions/Control_2
Consumption of the placebo food (once a day, 4 capsules each).
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) Male/female subjects ranging in age from 30 to 59 at informed consent.
(2) Subjects with less than 30.0 kg/m2 of BMI.
(3) Subjects who work as usual, except every weekend.
(4) Subjects having the habit of going to bed by 24 o'clock.
(5) Subjects with unsatisfactory sleep.
(6) Subjects who can give informed consent to partake in this study, after being provided with an explanation of the protocol detail.
Key exclusion criteria
Subjects - -
(1) taking in sleep-affecting foods (e.g., GABA), 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) with insomnia, sleep-apnea syndrome, restless legs one, overactive cystitis, reflux esophagitis,
(4) with affecting rhinitis or pollinosis,
(5) with a pacemaker,
(6) with an alcohol intake during the test period,
(7) having a habit of smoking,
(8) with previous medical history of mental disorder,
(9) with abnormal carbohydrate metabolism at pre-test 1,
(10) with medical history of serious diseases (e.g., cardiac),
(11) with extremely irregular life rhythm,
(12) planning affecting life-events during the test period,
(13) planning to go on a business/long/event trip during the brain-wave measuring period,
(14) with night urinations, not less than twice a day,
(15) cannot use a bedding by themselves,
(16) who might be woken up by a roomer during sleep,
(17) who have been diagnosed as dry mouth,
(18) with intraoral bleeding tendency,
(19) with pregnancy, possibly one, or lactating,
(20) with drug/food allergy,
(21) 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,
(22) who donated their blood components or blood (0.2 L) within the last month,
(23) who donated his blood (0.4 L) within the last 3 months,
(24) who donated her blood (0.4 L) within the last 4 months,
(25) being collected in total of his blood (1.2 L) within the last 12 months and in this study,
(26) being collected in total of her blood (0.8 L) within the last 12 months and in this study,
(27) who break out in a rash from putting electrodes on the head and neck,
(28) being determined as ineligible for participation by the principal/sub investigator - - .
Target sample size
140
Research contact person
Name of lead principal investigator
| 1st name | Toshiya |
| Middle name | |
| Last name | Kobayashi |
Organization
MEGMILK SNOW BRAND Co.,Ltd
Division name
Milk Science Research Institute
Zip code
350-1165
Address
1-1-2 Minamidai, Kawagoe, Saitama 350-1165, Japan
TEL
049-242-8111
t-kobayashi@meg-snow.com
Public contact
Name of contact person
| 1st name | Masanori |
| Middle name | |
| Last name | Numa |
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
MEGMILK SNOW BRAND 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 | 03 | Month | 06 | 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 | 02 | Month | 20 | Day |
Date of IRB
| 2023 | Year | 02 | Month | 17 | Day |
Anticipated trial start date
| 2023 | Year | 03 | Month | 06 | Day |
Last follow-up date
| 2023 | Year | 07 | Month | 02 | 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 | 02 | Month | 28 | Day |
Last modified on
| 2024 | Year | 01 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000057313
