Tokyo, Sept. 8 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000062836) titled 'An Exploratory Comparative Study to Evaluate the Effects of Hydrogen and Oxygen Co-Inhalation at Different Flow Rates on Natural Killer Cell Activity, Oxidative Stress Markers, and Blood Test Parameters in Middle-Aged and Older Adults' on Sept. 7.

Study Type: Interventional

Study Design: Basic Design - Parallel Randomization - Randomized Blinding - Open -no one is blinded Control - Dose comparison

Primary Sponsor: Institute - CPCC Company Limited

Condition: Condition - Male/female adults Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - To explore the effects of daily 60-minute co-inhalation of hydrogen and oxygen at different flow rates on various biological parameters, and to elucidate the associations between gas flow rates and biological responses. Basic objectives2 - Safety,Efficacy

Intervention: Interventions/Control_1 - Inhalation hydrogen and oxygen through a nasal cannula once daily for 60 minutes using the specified purified water. Interventions/Control_2 - Inhalation hydrogen and oxygen through a nasal cannula once daily for 60 minutes using the specified purified water.

Eligibility: Age-lower limit - 55 years-old

Gender - Male and Female Key inclusion criteria - 1. Males and females aged 55 years to less than 70 years at the time of informed consent. 2. Individuals who are able to give informed consent to participate in this study after receiving a detailed explanation of the protocol and understanding its contents. Key exclusion criteria - 1. Individuals who regularly consume Foods for Specified Health Uses, Foods with Function Claims, or health foods (including supplements) that may affect the study (immune or antioxidant function) four or more days per week. 2. Individuals who take medications that may affect the study outcomes, such as immunosuppressive or immunostimulatory agents, at least once per week. 3. Individuals who plan to stay overnight away from home, such as for travel, during the inhalation period. 4. Individuals who subjectively perceive themselves as experiencing fatigue on a daily basis. 5. Individuals who regularly use a hydrogen inhalation device at least twice per week, or who use such a device less than twice per week but are unable to discontinue its use during the study period. 6. Individuals who are participating in, have participated in within the four weeks prior to the current trial, or are planning to participate in clinical trials of pharmaceuticals or health foods. 7.Smoker. 8. Individuals with previous and/or current medical history of serious diseases in the heart, liver, kidneys, digestive organs, respiratory organs. 9. Females who are pregnant, breastfeeding, or intending to become pregnant during trial period. 10. Individuals who are aware that they are infected with viral hepatitis B or C, HIV, or syphilis, or who are determined to be positive for an infectious disease during the pre-use screening examination. 11. Individuals who donated 200 mL of their blood or blood components within the last month. 12. Individuals who donated 400 mL of his blood within the last 3 months. 13. Individuals who donated 400 mL of her blood within the last 4 months. 14. Individuals who have had a total of 1200 mL of his blood collected within the last 12 months, including in this study. 15. Individuals who have had a total of 800 mL of her blood collected within the last 12 months, including in this study. Target Size - 20

Recruitment Status: Recruitment status - Preinitiation Date of protocol fixation - 2026 Year 08 Month 26 Day Date of IRB - 2026 Year 08 Month 21 Day Anticipated trial start date - 2026 Year 09 Month 08 Day Last follow-up date - 2026 Year 11 Month 23 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071442

Disclaimer: Curated by HT Syndication.