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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000046580
Receipt No. 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 2022/01/07

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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
Email 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
Email eigyou27@kso.co.jp

Sponsor
Institute KSO Corporation
Institute
Department

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
Email 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 Preinitiation
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 01 Month 07 Day


Link to view the page
URL(English) https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053140

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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