Effects of Hydrogen Gas Inhalation on Adults of Various Ages

Alzheimer Disease Clinical Trial

Official title:

Effects of Hydrogen Gas Inhalation on Community-Dwelling Adults of Various Ages: A Single-Arm, Open-Label, Prospective Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05891938
• Other study ID #: EMB-2023-01
• Status: Completed
• Phase: N/A
• Start date: January 1, 2023
• Est. completion date: April 5, 2023

Study information

• Verified date: May 2023
• Source: Wonju Severance Christian Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Herein, investigated the effects of 4 weeks of H2 gas inhalation on community-dwelling adults of various ages.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 54
• Est. completion date: April 5, 2023
• Est. primary completion date: March 1, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 40 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Alzheimer Disease

Intervention

Other:
• H2 gas inhalation
H2 gas inhalation treatment for 4 weeks in on community dwelling adults of various ages

Locations

Country	Name	City	State
Korea, Republic of	Wonju College of Medicine	Wonju	Ganwon-do
Korea, Republic of	Wonju Severance Christian Hospital	Wonju	Gwando

Sponsors (1)

Lead Sponsor	Collaborator
Wonju Severance Christian Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	4 weeks
Primary	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	4 weeks
Secondary	Measurement of dementia biomarkers such as brain-derived neurotrophic factor (BDNF ng/mL)	4 weeks treatment of H2 gas treatment	4 weeks
Secondary	Measurement of dementia biomarkers such as brain-derived neurotrophic factor amyloid beta (Aß (pg/mL))	4 weeks treatment of H2 gas treatment	4 weeks
Secondary	Measurement of inflammatory markers such as interleukin 6 (pg/mL)	4 weeks treatment of H2 gas treatment	4 weeks