UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000046580 |
|---|---|
| Receipt number | R000053140 |
| Scientific Title | A study to confirm the effect of test food on Human brain fatigue recovery. -Open Study- |
| Date of disclosure of the study information | 2022/01/10 |
| Last modified on | 2022/03/30 15:33:32 |
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Basic information
Public title
A study to confirm the effect of test food on Human brain fatigue recovery.
-Open Study-
Acronym
A study to confirm the effect of test food on Human brain fatigue recovery.
Scientific Title
A study to confirm the effect of test food on Human brain fatigue recovery.
-Open Study-
Scientific Title:Acronym
A study to confirm the effect of test food on Human brain fatigue recovery.
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To verify the central fatigue recovery effect of test food on human intellectual workload (comparison before and after by Uchida-Kraepelin test).
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Fatigue VAS
Key secondary outcomes
POMS2 shortened version
Evaluation of autonomic nervous function
VAS when waking up
Cortisol in saliva
Alpha-amylase in saliva
SIgA in saliva
IgG in blood
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Take test food once a day, 3 capsules, for 4 weeks.
Interventions/Control_2
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
| 35 | years-old | <= |
Age-upper limit
| 60 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1. Males and females from 35 to 59 years of age.
2. Subjects who can make self-judgment and are voluntarily giving written informed consent.
Key exclusion criteria
1. Subjects with a history of severe liver disorder, renal disorder, or heart disease.
2. Subjects who are suffering from a disease and are going to the hospital, taking medication, or under treatment.
3. Subjects who are taking drugs, supplements or health foods related to recovery from fatigue and lack of sleep.
4. Subjects suspected of having depression, menopause, or sleep disorders as a result of screening tests.
5. Subjects who have been diagnosed with chronic fatigue syndrome.
6. Subjects who have test food allergy.
7. Those who are taking medicines or supplements that affect the research results.
8. Subjects who are pregnant or breast-feeding, or have the will of pregnancy during the study period.
9. Subjects with irregular shift work, late night work, etc.
10. Subjects who drink a lot of alcohol.
11. Subjects who participate in other clinical trials, who have participated in other tests within one month of obtaining consent, or who are willing to participate.
12. Subjects who are judged as unsuitable for the study by the investigator for the other reasons.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Yoshitaka |
| Middle name | |
| Last name | Iwama |
Organization
Nihonbashi Cardiology Clinic
Division name
Director
Zip code
103-0001
Address
Kyodo Bldg. #201, 13 - 4 Nihonbashi Kodenmacho, Chuo-ku, Tokyo
TEL
03-5641-4133
yiwama@well-sleep.jp
Public contact
Name of contact person
| 1st name | Eiji |
| Middle name | |
| Last name | Yoshikawa |
Organization
KSO Corporation
Division name
Sales department
Zip code
105-0023
Address
1-9-7 Shibaura, Minato-ku, Tokyo
TEL
03-3452-7733
Homepage URL
eigyou27@kso.co.jp
Sponsor or person
Institute
KSO Corporation
Institute
Department
Personal name
Funding Source
Organization
TEIJIN LIMITED
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
Ethical Committee of Nihonbashi Cardiology Clinic
Address
Kyodo Bldg. #201, 13 - 4 Nihonbashi Kodenmacho, Chuo-ku, Tokyo
Tel
03-5641-4133
niho-jimucho@well-sleep.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
| 2022 | Year | 01 | Month | 10 | 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
| 2021 | Year | 11 | Month | 29 | Day |
Date of IRB
| 2021 | Year | 12 | Month | 01 | Day |
Anticipated trial start date
| 2022 | Year | 01 | Month | 10 | Day |
Last follow-up date
| 2022 | Year | 02 | Month | 26 | 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 | 01 | Month | 07 | Day |
Last modified on
| 2022 | Year | 03 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053140
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
