Tokyo, Oct. 31 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000057949) titled 'Biological Responses to High-Concentration Oxygen Inhalation' on Oct. 30.

Study Type: Interventional

Study Design: Basic Design - Single arm Randomization - Non-randomized Blinding - Open -no one is blinded Control - Historical

Primary Sponsor: Institute - Tohoku University

Condition: Condition - healthy people Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - Although normobaric high-concentration oxygen is used in medical settings, it is also expected to have effects such as fatigue recovery in healthy individuals. As a result, temporary oxygen supplementation services, such as oxygen generators and oxygen capsules, have become readily available to the general public. However, excessive oxygen inhalation carries risks such as oxygen toxicity and the accumulation of oxidative stress. Therefore, in order to safely use oxygen in daily life, it is critically important to appropriately evaluate oxidative stress and oxygen toxicity. This study aims to analyze changes in exhaled components before and after oxygen inhalation, investigate the production dynamics of supersulfide metabolites and oxidative stress biomarkers in exhaled breath, and establish a non-invasive method for evaluating oxygen stress. Ultimately, the goal is to assess the oxygen tolerance capacity of healthy individuals exposed to oxygen inhalation. Basic objectives2 - Safety

Intervention: Interventions/Control_1 - After having breakfast:

Exhaled breath condensate will be collected for 20 minutes starting at 8:40 a.m.

From 9:00 a.m. to 11:00 a.m., subjects will inhale 40% oxygen for 120 minutes. During this period, exhaled breath condensate will be collected concurrently in six intervals: 0-20 minutes, 20-40 minutes, 40-60 minutes, 60-80 minutes, 80-100 minutes, and 100-120 minutes from the start of oxygen inhalation.

Immediately after the completion of oxygen inhalation, exhaled breath condensate will be collected for another 20 minutes.

An additional 20-minute breath condensate sample will be collected starting 60 minutes after the end of oxygen inhalation. The procedure will conclude at 12:20 p.m.

Eligibility: Age-lower limit - 20 years-old = Gender - Male and Female Key inclusion criteria - Healthy men and women aged 20 to 40 years at the time of enrollment Key exclusion criteria - Not currently taking any medications

Not undergoing dental treatment

Willing to refrain from alcohol consumption and strongly flavored foods such as garlic during the study period Target Size - 10

Recruitment Status: Recruitment status - Preinitiation Date of protocol fixation - 2025 Year 06 Month 10 Day Anticipated trial start date - 2025 Year 06 Month 10 Day Last follow-up date - 2025 Year 06 Month 29 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066253

Disclaimer: Curated by HT Syndication.