UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057211 |
|---|---|
| Receipt number | R000065397 |
| Scientific Title | Research on human biological responses in unusual environments |
| Date of disclosure of the study information | 2025/03/07 |
| Last modified on | 2025/03/06 10:22:37 |
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Basic information
Public title
Research on human biological responses in unusual environments
Acronym
Research on human biological responses in unusual environments
Scientific Title
Research on human biological responses in unusual environments
Scientific Title:Acronym
Research on human biological responses in unusual environments
Region
| Japan |
Condition
Condition
Healthy individuals
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to clarify the effects on the living body of physical exercise, which is believed to contribute to the maintenance and promotion of health, at rest in special environments (normal pressure low oxygen to high pressure high oxygen environments). In addition, the effects of various nutritional components and health foods will be investigated. As basic research, we will clarify the human heart rate, blood pressure, pulse rate, vascular endothelial function responses (UNEX EF device), cognitive function (Stroop test), etc., at rest in special environments. We will also clarify the effects on the living body of oral administration of eicosapentaenoic acid (EPA), a health food component, during physical exercise.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Based on a standard normal environment (1 atm, 20.9% O2), the biological responses of humans during rest and exercise will be confirmed in environments (arena laboratory) that vary from normal pressure hypoxia (1 atm, approximately 15% O2) to hyperbaric hyperxia (1.4 atm, approximately 40% O2) (n=60). Half of the subjects will be in the normal oxygen control group. The duration of the stay will be approximately 60 minutes per session. The planned period is 3 days per week for 8 weeks. Physical exercise load will be 60-70% VO2peak, 45 minutes, 2 days per week for 8 weeks using a bicycle ergometer or treadmill (part of the exercise will be field testing). The orally administered ingredient will be EPA70BAPT soft capsules (Bizen Kasei Co., Ltd.). Subjects will be required to take the capsules before, during, and after the experiment. Evaluation items will include morphology, body composition, blood pressure, vascular endothelial function, and cognitive function.
Key secondary outcomes
In order to confirm the absorption of fatty acids and changes in metabolites due to EPA intake, the fatty acid composition in the blood (whole blood and plasma) will be measured. In addition, because of the intake of food ingredients and exercise load, blood biochemistry (neutral fats, cholesterol, etc.) will also be measured.
Number of blood samples required for biochemistry analysis: Three times during the period, before, during and after the test.
Amount per sample: 10 mL of blood (blood collection tube) will be collected.
Plasma preparation and storage method: Blood will be collected in a blood collection tube for plasma, and the plasma obtained by centrifugation will be dispensed into tubes at 1 mL each. Store at -20C.Blood biochemistry and fatty acid measurement method: Plasma will be sent to SRL Co., Ltd. (SRL) to commission the measurement of blood biochemistry parameters. Plasma fatty acid analysis will also be sent to SRL, where the fatty acids in the plasma will be methylated and then analyzed by gas chromatography to measure the amount of fatty acids per mL of plasma.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Food |
Interventions/Control_1
Take 2 mg of EPA70BAPT soft capsules (Bizen Kasei Co., Ltd.) per day
Interventions/Control_2
EPA70BAPT soft capsule (Bizen Kasei Co., Ltd.) 2 mg taken per day
Physical exercise load using a bicycle ergometer for 45 minutes, 2 days a week, for 8 weeks
Interventions/Control_3
Take 2mg of EPA70BAPT soft capsules (Bizen Kasei Co., Ltd.) per day
Perform physical exercise on a bicycle ergometer for 45 minutes, 2 days a week, for 8 weeks
Perform physical exercise at a high oxygen load of 60-70% VO2peak
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
| 18 | years-old | <= |
Age-upper limit
| 40 | years-old | >= |
Gender
Male
Key inclusion criteria
Healthy adult male
Key exclusion criteria
Unhealthy people
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Nakao |
| Middle name | |
| Last name | Takehira |
Organization
Kyushu Sangyo University
Division name
Department of Human Sciences, Sports and Health Sciences
Zip code
813-8503
Address
2-3-1 Matsukadai, Higashi-ku, Fukuoka City, Fukuoka Prefecture
TEL
092-673-5866
takehira@ip.kyusan-u.ac.jp
Public contact
Name of contact person
| 1st name | Yoshikawa |
| Middle name | |
| Last name | Keisuke |
Organization
Saitama Medical University
Division name
Pharmacology, Faculty of Medicine
Zip code
350-0495
Address
38 Morohongo, Moroyama-cho, Iruma-gun, Saitama Prefecture
TEL
049-276-1157
Homepage URL
keisukey@saitama-med.ac.jp
Sponsor or person
Institute
others
Institute
Department
Personal name
Takehira Nakao
Funding Source
Organization
Ministry of Education, Culture, Sports, Science and Technology
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kyushu Sangyo University, Industry-Academia Collaboration Support Office
Address
2-3-1 Matsukadai, Higashi-ku, Fukuoka City, Fukuoka Prefecture
Tel
092-673-5501
sangaku@ip.kyusan-u.ac.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
| 2025 | Year | 03 | Month | 07 | 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
30
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
No longer recruiting
Date of protocol fixation
| 2020 | Year | 02 | Month | 26 | Day |
Date of IRB
| 2023 | Year | 12 | Month | 18 | Day |
Anticipated trial start date
| 2023 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2030 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2025 | Year | 03 | Month | 05 | Day |
Last modified on
| 2025 | Year | 03 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000065397
