NCT05891938

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
54

participants targeted

Target at P25-P50 for not_applicable alzheimer-disease

Timeline
Completed

Started Jan 2023

Shorter than P25 for not_applicable alzheimer-disease

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2023

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2023

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

April 5, 2023

Completed
26 days until next milestone

First Submitted

Initial submission to the registry

May 1, 2023

Completed
1 month until next milestone

First Posted

Study publicly available on registry

June 7, 2023

Completed
Last Updated

June 7, 2023

Status Verified

May 1, 2023

Enrollment Period

2 months

First QC Date

May 1, 2023

Last Update Submit

June 6, 2023

Conditions

Alzheimer Disease

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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 Outcomes (3)

  • Measurement of dementia biomarkers such as brain-derived neurotrophic factor (BDNF ng/mL)

    4 weeks

  • Measurement of dementia biomarkers such as brain-derived neurotrophic factor amyloid beta (Aβ (pg/mL))

    4 weeks

  • Measurement of inflammatory markers such as interleukin 6 (pg/mL)

    4 weeks

Study Arms (1)

Single arm

EXPERIMENTAL

Single group treatment

Other: H2 gas inhalation

Interventions

H2 gas inhalationOTHER

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

Single arm

Eligibility Criteria

Age40 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Participants excluded those who have any disease
  • Pregnant and lactating women

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Wonju College of Medicine

Wŏnju, Ganwon-do, 26426, South Korea

Location

Wonju Severance Christian Hospital

Wŏnju, Gwando, 26426, South Korea

Location

MeSH Terms

Conditions

Alzheimer Disease

Condition Hierarchy (Ancestors)

DementiaBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesTauopathiesNeurodegenerative DiseasesNeurocognitive DisordersMental Disorders

Study Officials

  • Prof. Kyu Jae Lee, Ph.D.

    Wonju College of Medicine

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Masking Details
Before and after of treatment in single group
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Model Details: Single Group Assignment
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

May 1, 2023

First Posted

June 7, 2023

Study Start

January 1, 2023

Primary Completion

March 1, 2023

Study Completion

April 5, 2023

Last Updated

June 7, 2023

Record last verified: 2023-05

Data Sharing

IPD Sharing
Will not share

Locations

KR(2)