UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000062836 |
|---|---|
| Receipt number | R000071442 |
| Scientific Title | 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 |
| Date of disclosure of the study information | 2026/09/07 |
| Last modified on | 2026/09/07 13:23:02 |
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Basic information
Public title
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
Acronym
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
Scientific Title
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
Scientific Title:Acronym
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
Region
| Japan |
Condition
Condition
Male/female adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
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
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Natural killer cell activity
Key secondary outcomes
d-ROMs (derivatives of reactive oxygen metabolites)
Subjective questionnaire assessments
Hematological parameters
Blood biochemical parameters
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Dose comparison
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Other |
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.
Interventions/Control_3
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
| 55 | years-old | <= |
Age-upper limit
| 70 | 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 sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Yoshimi |
| Middle name | |
| Last name | Suzuki |
Organization
MAKE MEDICAL CO.,LTD.
Division name
Representative Director
Zip code
104-0061
Address
MAKE Building, 5-14-3 Ginza, Chuo-ku, Tokyo, Japan
TEL
03-6824-4345
suzuki@make-medical.com
Public contact
Name of contact person
| 1st name | Masanori |
| Middle name | |
| Last name | Numa |
Organization
CPCC Company Limited
Division name
Clinical Planning Department
Zip code
103-0021
Address
4F Daiwa Building, 3-3-10 Nihonbashi-Hongoku-Cho, Chuo-ku, Tokyo, Japan
TEL
03-6225-9001
Homepage URL
cpcc-contact@cpcc.co.jp
Sponsor or person
Institute
CPCC Company Limited
Institute
Department
Personal name
Funding Source
Organization
MAKE MEDICAL 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
Institutional Review Board of Chiyoda Paramedical Care Clinic
Address
2F Daiwa Building, 3-3-10 Nihonbashi-Hongoku-Cho, Chuo-ku, Tokyo 103-0021, Japan
Tel
03-6225-9005
IRB@cpcc.co.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
| 2026 | Year | 09 | 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
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
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 |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
(Exclusion criteria continued)
16. Individuals deemed unsuitable for participation in the study by the principal investigator or sub-investigator.
Management information
Registered date
| 2026 | Year | 09 | Month | 07 | Day |
Last modified on
| 2026 | Year | 09 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071442
