Research on human biological responses in unusual environments

UMIN ID: UMIN000057211

Registered date:07/03/2025

Basic Information

• Recruitment status: Complete: follow-up continuing
• Health condition(s) or Problem(s) studied: Healthy individuals
• Date of first enrollment: 2023/07/01
• Target sample size: 60
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

Take 2 mg of EPA70BAPT soft capsules (Bizen Kasei Co., Ltd.) per day
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
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

Outcome(s)

• Primary Outcome: 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.
• Secondary Outcome: 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.

Key inclusion & exclusion criteria

• Age minimum: 18years-old
• Age maximum: 40years-old
• Gender: Male
• Exclude criteria: Unhealthy people

Related Information

• Primary Sponsor: others
• Source(s) of Monetary Support: Ministry of Education, Culture, Sports, Science and Technology