UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000037893 |
|---|---|
| Receipt number | R000043197 |
| Scientific Title | A confirmation test of the influence for sleep, stress and feeling of fatigue, caused by test food consumption |
| Date of disclosure of the study information | 2020/09/04 |
| Last modified on | 2020/10/09 11:57:58 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
A confirmation test of the influence for sleep, stress and feeling of fatigue, caused by test food consumption
Acronym
A confirmation test of the influence for sleep, stress and feeling of fatigue, caused by test food consumption
Scientific Title
A confirmation test of the influence for sleep, stress and feeling of fatigue, caused by test food consumption
Scientific Title:Acronym
A confirmation test of the influence for sleep, stress and feeling of fatigue, caused by test food consumption
Region
| Japan |
Condition
Condition
Not applicable
Classification by specialty
| Not applicable |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Confirm the influence for sleep, stress and feeling of fatigue caused by two weeks consumption of test food.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Condition of sleep, stress and fatigue, assessed by electroencephalography, OSA sleep inventory, VAS questionnaire for feeling of fatigue, POMS2 short version or St. Mary's hospital sleep questionnaire
Key secondary outcomes
Incidence rate of adverse events and side effects
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
Prevention
Type of intervention
| Food |
Interventions/Control_1
Intake test food for two weeks. Rest for two weeks. Intake control food for two weeks.
Interventions/Control_2
Intake control food for two weeks. Rest for two weeks. Intake test food for two 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. Japanese males and females aged 20 to 64 years old and who are dissatisfied their sleep.
2. Subjects who have a custom of going bed before 24 o'clock
3. Subjects their score of Athens Insomnia Scale are between 6 and 9.
4. Subjects who receive enough explain of the test, who deeply understanding of the test, and who obtain own consent to participate the test.
Key exclusion criteria
Subjects who
1.are given continuous treatment by taking medicines.
2.constantly use oral medicines having a possibility of affecting test results.
3.constantly use food having a possibility of affecting test results, such as food for specific health use.
4.have current and/or previous medical history of serious disease.
5.have current and/or previous medical history of sleep disorder.
6.self-aware about their sleep apnea.
7.awake during sleep more than two times a week due to night urination.
8.have allergic rhinitis.
9.use pacemaker.
10.have previous medical history of allergy for medicine and/or food.
11.those BMI are over 30 kg/m2.
12.tend to have skin rash with adhesive tape due to skin hypersensitivity.
13.are pregnant or lactating.
14.have extremely irregular dining and life habits.
15.excessive alcohol intake.
16.are not be able to avoid alcohol intake during test period.
17.are not be able to use electroencephalograph during test period.
18.have plan lodging by travel and/or business trip.
19.are participating the other clinical tests, participated within 4-weeks prior to the current study and/or plan to participate the other clinical tests.
20.donated over 200mL blood and/or blood components within the last one month.
And
21.Males who donated over 400mL blood and/or blood components within the last three month.
22.Females who donated over 400mL blood and/or blood components within the last four month.
23.Males who will be collected over 1200mL blood and/or blood components, when the sampling amounts within the last twelve month are adding to the planned sampling amounts of this study.
24.Females who will be collected over 800mL blood and/or blood components when, the sampling amounts within the last twelve month are adding to the planned sampling amounts of this study.
25.Others who have been determined ineligible by principal investigator or sub-investigator.
Target sample size
25
Research contact person
Name of lead principal investigator
| 1st name | Kazuhiko |
| Middle name | |
| Last name | Kawaguchi |
Organization
Nippon Chemiphar Co., Ltd.
Division name
Medical Affairs Department
Zip code
101-0032
Address
2-2-3, Iwamoto-cho, Chiyoda-ku, Tokyo 101-0032, Japan
TEL
03-3863-1211
kazuhiko-kawaguchi@chemiphar.co.jp
Public contact
Name of contact person
| 1st name | Makoto |
| Middle name | |
| Last name | Ichinohe |
Organization
CPCC Company Limited
Division name
Planning & Sales Department
Zip code
101-0047
Address
4F Sanwauchikanda Building, 3-3-5 Uchikanda Chiyoda-ku, Tokyo 101-0047, JAPAN
TEL
03-5297-3112
Homepage URL
cpcc-contact@cpcc.co.jp
Sponsor or person
Institute
CPCC Company Limited
Institute
Department
Personal name
Funding Source
Organization
Nippon Chemiphar 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 Sanwauchikanda Building, 3-3-5 Uchikanda Chiyoda-ku, Tokyo 101-0047, Japan
Tel
03-5297-5548
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
| 2020 | Year | 09 | Month | 04 | 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
| 2019 | Year | 08 | Month | 19 | Day |
Date of IRB
| 2019 | Year | 08 | Month | 16 | Day |
Anticipated trial start date
| 2019 | Year | 09 | Month | 05 | Day |
Last follow-up date
| 2019 | Year | 11 | Month | 09 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2019 | Year | 09 | Month | 02 | Day |
Last modified on
| 2020 | Year | 10 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043197
