Effects of Hydrogen Gas Inhalation on Adults of Various Ages

June 6, 2023 updated by: Kyu Jae Lee, Wonju Severance Christian Hospital

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

54

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
    • Ganwon-do
      • Wonju, Ganwon-do, Korea, Republic of, 26426
        • Wonju College of Medicine
    • Gwando
      • Wonju, Gwando, Korea, Republic of, 26426
        • WonJu Severance Christian Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Single arm
Single group treatment
Other: H2 gas inhalation
H2 gas inhalation treatment for 4 weeks in on community dwelling adults of various ages

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
4 weeks
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
4 weeks

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Wonju Severance Christian Hospital

Investigators

  • Study Chair: Prof. Kyu Jae Lee, Ph.D., Wonju College of Medicine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2023

Primary Completion (Actual)

March 1, 2023

Study Completion (Actual)

April 5, 2023

Study Registration Dates

First Submitted

May 1, 2023

First Submitted That Met QC Criteria

June 6, 2023

First Posted (Actual)

June 7, 2023

Study Record Updates

Last Update Posted (Actual)

June 7, 2023

Last Update Submitted That Met QC Criteria

June 6, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EMB-2023-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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