Alzheimer DiseaseNCT05891938
Effects of Hydrogen Gas Inhalation on Adults of Various Ages
A study testing H2 gas inhalation in people with Alzheimer Disease, run by Wonju Severance Christian Hospital at 2 sites in South Korea.
Trial summary
Herein, investigated the effects of 4 weeks of H2 gas inhalation on community-dwelling adults of various ages. Read more about this study
- Who is it for?
- Ages 40 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Alzheimer Disease
- What is being tested?
- H2 gas inhalation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 2 sitesSouth Korea
- Study dates
- 1 Jan 2023to 5 Apr 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age ranges 40-70 years
- Healthy participants
- Patients who are willing or able to follow the doctor's instructions
- Fully understand the purpose and procedure of this clinical trial
Who cannot join
- Participants excluded those who have any disease
- Pregnant and lactating women
Trial locations and contacts
2 sites in 1 country.
South Korea2 sites
Wonju College of Medicine
Wŏnju, Ganwon-do, 26426
Wonju Severance Christian Hospital
Wŏnju, Gwando, 26426
About this study
Official title: Effects of Hydrogen Gas Inhalation on Community-Dwelling Adults of Various Ages: A Single-Arm, Open-Label, Prospective Clinical Trial
Herein, investigated the effects of 4 weeks of H2 gas inhalation on community-dwelling adults of various ages.
Read the detailed description
Molecular hydrogen (H2) is a versatile therapeutic agent. H2 gas inhalation is reportedly safe and has a positive impact on a range of illnesses, including Alzheimer's disease (AD). Herein, investigated the effects of 4 weeks of H2 gas inhalation on community-dwelling adults of various ages. Fifty-four participants including those dropped out (5%) were screened and enrolled. The selected participants were treated as a single group without randomization. Evaluated the association between total and differential white blood cell (WBC) counts and AD risk at individual levels after 4 weeks of H2 gas inhalation treatment. Furthermore, evaluation of dementia-related biomarkers such as beta-site APP cleaving enzyme 1 (BACE-1), amyloid beta (Aβ), brain-derived neurotrophic factor (BDNF), vascular endothelial growth factor A (VEGF-A), T-tau, monocyte chemotactic protein-1 (MCP-1), and inflammatory cytokines (interleukin-6).
- Conditions
- Alzheimer Disease
- Being tested
- H2 gas inhalation
- Medical subject headings
- Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
H2 gas inhalationOther
H2 gas inhalation treatment for 4 weeks in on community dwelling adults of various ages
| Study group | Role | What they receive |
|---|---|---|
| Single arm | Experimental | Single group treatment Receives: Other: H2 gas inhalation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measurement of white blood cell and its differential counts such as neutrophils (%), basophils (%)
4 weeks treatment of H2 gas inhalation in community dwelling adults of various ages
Measured: 4 weeks
Measurement of oxidative stress markers such as reactive oxygen species (µM), and nitric oxide (µM)
4 weeks treatment of H2 gas inhalation in community dwelling adults of various ages
Measured: 4 weeks
Secondary outcomes (3)
Measurement of dementia biomarkers such as brain-derived neurotrophic factor (BDNF ng/mL)
4 weeks treatment of H2 gas treatment
Measured: 4 weeks
Measurement of dementia biomarkers such as brain-derived neurotrophic factor amyloid beta (Aβ (pg/mL))
4 weeks treatment of H2 gas treatment
Measured: 4 weeks
Measurement of inflammatory markers such as interleukin 6 (pg/mL)
4 weeks treatment of H2 gas treatment
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2023
- Study start1 Jan 2023
- Primary completion1 Mar 2023
- Study completion5 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alzheimer DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Single Group Assignment
- Masking
- None (open label)
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wonju Severance Christian Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kyu Jae Lee, Wonju Severance Christian Hospital
- Investigators
- Prof. Kyu Jae Lee, Ph.D., Study chair, Wonju College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05891938
- Sponsor's protocol ID
- EMB-2023-01
- Status last verified
- May 2023
- First submitted
- 1 May 2023
- Last updated
- 7 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Hydrogen Gas Inhalation on Community-Dwelling Adults of Various Ages: A Single-Arm, Open-Label, Prospective Clinical Trial
- ClinicalTrials.gov ID
- NCT05891938
- Acronym / sponsor ID
- EMB-2023-01
- Conditions
- Alzheimer Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- Wonju Severance Christian HospitalUniversity, hospital or other
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- 1 Mar 2023 (actual)
- Study completion
- 5 Apr 2023 (actual)
- First posted
- 7 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Herein, investigated the effects of 4 weeks of H2 gas inhalation on community-dwelling adults of various ages.
Detailed description
Molecular hydrogen (H2) is a versatile therapeutic agent. H2 gas inhalation is reportedly safe and has a positive impact on a range of illnesses, including Alzheimer's disease (AD). Herein, investigated the effects of 4 weeks of H2 gas inhalation on community-dwelling adults of various ages. Fifty-four participants including those dropped out (5%) were screened and enrolled. The selected participants were treated as a single group without randomization. Evaluated the association between total and differential white blood cell (WBC) counts and AD risk at individual levels after 4 weeks of H2 gas inhalation treatment. Furthermore, evaluation of dementia-related biomarkers such as beta-site APP cleaving enzyme 1 (BACE-1), amyloid beta (Aβ), brain-derived neurotrophic factor (BDNF), vascular endothelial growth factor A (VEGF-A), T-tau, monocyte chemotactic protein-1 (MCP-1), and inflammatory cytokines (interleukin-6).
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single Group Assignment
| Arm | Type | Receives |
|---|---|---|
| Single arm | Experimental | Other: H2 gas inhalationSingle group treatment |
Who may qualify
- Ages
- 40 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age ranges 40-70 years
- Healthy participants
- Patients who are willing or able to follow the doctor's instructions
- Fully understand the purpose and procedure of this clinical trial
Key exclusion criteria (2 listed)
- Participants excluded those who have any disease
- Pregnant and lactating women
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| H2 gas inhalationH2 gas inhalation treatment for 4 weeks in on community dwelling adults of various ages | Other | Single arm |
Primary outcome
Measurement of white blood cell and its differential counts such as neutrophils (%), basophils (%)
Time frame: 4 weeks
4 weeks treatment of H2 gas inhalation in community dwelling adults of various ages
Measurement of oxidative stress markers such as reactive oxygen species (µM), and nitric oxide (µM)
Time frame: 4 weeks
4 weeks treatment of H2 gas inhalation in community dwelling adults of various ages
3 secondary outcomes
Measurement of dementia biomarkers such as brain-derived neurotrophic factor (BDNF ng/mL)
Time frame: 4 weeks
Measurement of dementia biomarkers such as brain-derived neurotrophic factor amyloid beta (Aβ (pg/mL))
Time frame: 4 weeks
Measurement of inflammatory markers such as interleukin 6 (pg/mL)
Time frame: 4 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jun 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Prof. Kyu Jae Lee, Ph.D. study chair
Wonju College of Medicine
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing H2 gas inhalation in people with Alzheimer Disease, run by Wonju Severance Christian Hospital at 2 sites in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measurement of white blood cell and its differential counts such as neutrophils (%), basophils (%) (time frame: 4 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jun 2023; AzTrials last refreshed its copy on 8 Nov 2026.