search
Back to results

Effects of Hydrogen Gas Inhalation on Adults of Various Ages

Primary Purpose

Alzheimer Disease

Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
H2 gas inhalation
Sponsored by
Wonju Severance Christian Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Alzheimer Disease

Eligibility Criteria

40 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion 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 Exclusion Criteria Participants excluded those who have any disease Pregnant and lactating women

Sites / Locations

  • Wonju College of Medicine
  • Wonju Severance Christian Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Single arm

Arm Description

Single group treatment

Outcomes

Primary Outcome Measures

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
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

Secondary Outcome Measures

Measurement of dementia biomarkers such as brain-derived neurotrophic factor (BDNF ng/mL)
4 weeks treatment of H2 gas treatment
Measurement of dementia biomarkers such as brain-derived neurotrophic factor amyloid beta (Aβ (pg/mL))
4 weeks treatment of H2 gas treatment
Measurement of inflammatory markers such as interleukin 6 (pg/mL)
4 weeks treatment of H2 gas treatment

Full Information

First Posted
May 1, 2023
Last Updated
June 6, 2023
Sponsor
Wonju Severance Christian Hospital
search

1. Study Identification

Unique Protocol Identification Number
NCT05891938
Brief Title
Effects of Hydrogen Gas Inhalation on Adults of Various Ages
Official Title
Effects of Hydrogen Gas Inhalation on Community-Dwelling Adults of Various Ages: A Single-Arm, Open-Label, Prospective Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Completed
Study Start Date
January 1, 2023 (Actual)
Primary Completion Date
March 1, 2023 (Actual)
Study Completion Date
April 5, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Wonju Severance Christian Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alzheimer Disease

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Single Group Assignment
Masking
None (Open Label)
Masking Description
Before and after of treatment in single group
Allocation
N/A
Enrollment
54 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Single arm
Arm Type
Experimental
Arm Description
Single group treatment
Intervention Type
Other
Intervention Name(s)
H2 gas inhalation
Intervention Description
H2 gas inhalation treatment for 4 weeks in on community dwelling adults of various ages
Primary Outcome Measure Information:
Title
Measurement of white blood cell and its differential counts such as neutrophils (%), basophils (%)
Description
4 weeks treatment of H2 gas inhalation in community dwelling adults of various ages
Time Frame
4 weeks
Title
Measurement of oxidative stress markers such as reactive oxygen species (µM), and nitric oxide (µM)
Description
4 weeks treatment of H2 gas inhalation in community dwelling adults of various ages
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
Measurement of dementia biomarkers such as brain-derived neurotrophic factor (BDNF ng/mL)
Description
4 weeks treatment of H2 gas treatment
Time Frame
4 weeks
Title
Measurement of dementia biomarkers such as brain-derived neurotrophic factor amyloid beta (Aβ (pg/mL))
Description
4 weeks treatment of H2 gas treatment
Time Frame
4 weeks
Title
Measurement of inflammatory markers such as interleukin 6 (pg/mL)
Description
4 weeks treatment of H2 gas treatment
Time Frame
4 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion 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 Exclusion Criteria Participants excluded those who have any disease Pregnant and lactating women
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Prof. Kyu Jae Lee, Ph.D.
Organizational Affiliation
Wonju College of Medicine
Official's Role
Study Chair
Facility Information:
Facility Name
Wonju College of Medicine
City
Wonju
State/Province
Ganwon-do
ZIP/Postal Code
26426
Country
Korea, Republic of
Facility Name
Wonju Severance Christian Hospital
City
Wonju
State/Province
Gwando
ZIP/Postal Code
26426
Country
Korea, Republic of

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Effects of Hydrogen Gas Inhalation on Adults of Various Ages

We'll reach out to this number within 24 hrs