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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000037893
Receipt No. 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

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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
Email 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
Email cpcc-contact@cpcc.co.jp

Sponsor
Institute CPCC Company Limited
Institute
Department

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
Email 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043197

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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