UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000042983 |
|---|---|
| Receipt number | R000049029 |
| Scientific Title | A study investigating the relationship between physical condition and the brain function in healthy adult males |
| Date of disclosure of the study information | 2022/03/26 |
| Last modified on | 2022/01/13 13:30:56 |
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Basic information
Public title
A study investigating the relationship between physical condition and the brain function in healthy adult males
Acronym
A study investigating the relationship between physical condition and the brain function in healthy adult males
Scientific Title
A study investigating the relationship between physical condition and the brain function in healthy adult males
Scientific Title:Acronym
A study investigating the relationship between physical condition and the brain function in healthy adult males
Region
| Japan |
Condition
Condition
Healthy subjects
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the relationships between changes in body temperature and the brain function in healthy adult males
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
(Evaluation items)
Changes in the result of Uchida Kraepelin test, Stroop test, and Paced Auditory Serial Addition Test (PASAT); changes in body temperature; changes in cerebral blood flow; changes in the result of subjective evaluation questionnaire by Visual Analog Scale (VAS)
Key secondary outcomes
(Exploratory evaluation items)
Heart rate and heart rate variability, blood glucose level, hematocrit level, and serum osmolality
(Safety evaluation)
Frequency of adverse events during the study, general physical findings, and vital signs
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
4
Purpose of intervention
Prevention
Type of intervention
| Food | Other |
Interventions/Control_1
Maintenance of body temperature and intake of the test food
Interventions/Control_2
Maintenance of body temperature and intake of the control food
Interventions/Control_3
Thermal load to increase body temperature and intake of the test food
Interventions/Control_4
Thermal load to increase body temperature and intake of the control food
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
| 40 | years-old | > |
Gender
Male
Key inclusion criteria
1) Subject who gave written consent for participation in the research
2) Healthy male
3) Age at the time of obtaining consent is 20 to 40 years old
4) Body mass index (BMI) is 18.5 or more and less than 25 (normal weight)
5) Subject who habitually eats breakfast for 4 days or more in a week
6) Subject who does not work in shifts or night shift
7) Right-handed subject
8) Subject who does not smoke
9) Subject who can carry out the test according to the schedule and procedure specified by the researcher
Key exclusion criteria
1) Subject who has collected 200 mL or more of whole blood within 4 weeks, or 400 mL or more of whole blood within 12 weeks, prior to the first blood collection
2) Subject whose clinical laboratory test values deviate from the normal range and are judged by the principal investigator to be ineligible for this study
3) Subject with any medical history of brain, nerve, psychiatry, circulatory system, endocrine function, or color vision deficiency who is judged by the principal investigator to be ineligible for this study
4) Subject whose rise in sublingual temperature is 1 degree Celsius or more, or less than 0.1 degree Celsius during the thermal load performed at a screening test
5) Subject whose total number of correct answers in Kraepelin test conducted at the screening test exceeds the average value plus-minus 2SD
6) Subject who cannot drink the specified amount of the test food
7) Subject who has used health foods or drugs and the principal investigator has determined that the usage affect the evaluation of the outcomes
8) Subject who is estimated inappropriate to this study by principal investigators
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Shingo |
| Middle name | |
| Last name | Miyamoto |
Organization
Otsuka Pharmaceutical Co., Ltd.
Division name
Saga Nutraceuticals Research Institute
Zip code
842-0195
Address
5006-5 Aza Higashiyama, Omagari, Yoshinogari-cho, Kanzaki-gun, Saga 842-0195, Japan
TEL
0952-52-1522
Miyamoto.Shingo@otsuka.jp
Public contact
Name of contact person
| 1st name | Daisuke |
| Middle name | |
| Last name | Ochitani |
Organization
HUMA R&D CORP
Division name
Clinical Development Division
Zip code
108-0014
Address
Round Cross Tamachi 10F, 5-31-19 Shiba, Minato-ku, Tokyo 108-0014, Japan
TEL
03-3431-1260
Homepage URL
ochitani@huma-rd.co.jp
Sponsor or person
Institute
HUMA R&D CORP
Institute
Department
Personal name
Funding Source
Organization
Otsuka Pharmaceutical 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
Ethics Committees of Yoga Allergy Clinic
Address
4-32-16 Yoga, Setagaya-ku, Tokyo 158-0097, Japan
Tel
03-5491-4478
info@yg-allergy.com
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 | 03 | Month | 26 | 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 | 01 | Month | 08 | Day |
Date of IRB
| 2021 | Year | 01 | Month | 15 | Day |
Anticipated trial start date
| 2021 | Year | 01 | Month | 16 | Day |
Last follow-up date
| 2021 | Year | 03 | Month | 26 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Ethics Committees of Yoga Allergy Clinic took over the IRB review process owing to the closing of Ethics Committees of Nihonbashi Egawa Clinic. The research was reviewed and approved by the new IRB on Feb 12th, 2021.
Management information
Registered date
| 2021 | Year | 01 | Month | 12 | Day |
Last modified on
| 2022 | Year | 01 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049029
