A Dosing Study of Hyperbaric Oxygen Therapy (HBOT) on Epigenetic Aging

Aging Clinical Trial

— HBOT  

Official title:

Hyperbaric Dosage Analysis Effect Of Various PO2 Exposures: Hyperoxia-Hypoxia Paradox On Stem Cell Mobilization, Cell Signaling, Inflammation, Epigenetics & Cell Regeneration

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05297019
• Other study ID #: SM-TD-001
• Status: Active, not recruiting
• Phase: Phase 2/Phase 3
• Start date: March 1, 2022
• Est. completion date: July 1, 2023

Study information

• Verified date: April 2023
• Source: TruDiagnostic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study aims to assess the impact of hyperbaric oxygen therapy on a number of outcomes, including epigenetic aging, inflammation, and cellular health.

Description:

While current research has identified many mechanisms of action, effects and cell signaling benefits resulting from HBOT, we do not have a firm understanding of the timeframe and dosage for many of these expected adaptations. Data from this study will be collected and shared on an ongoing basis throughout the course of care. This research project will help us to confirm these cell-signaling changes and benefits, and also develop a better understanding of the necessary PO2 and time frame required in order to achieve these changes leading to improved patient outcomes in the field of hyperbaric medicine.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 30
• Est. completion date: July 1, 2023
• Est. primary completion date: April 30, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 40 Years to 70 Years

Eligibility

Inclusion Criteria:

1. Any sex, gender orientation, and ethnicity

2. Between ages 40 and 70

3. Must be willing and able to participate in venipuncture, health history and clinical assessments, lab test assessment, hyperbaric oxygen treatment.

4. Participants must also agree to maintain their current lifestyle choices consistent with pre- participation with this study. Participants should not change their exercise programs, diets, sleep patterns supplements or other. Any significant changes in their lifestyle choices must be reported to the staff.

Exclusion Criteria:

1. Significant change in diagnosis and/or treatment of major illness or injury within 2 years prior to screening, e.g., diabetes, cancer, cardiovascular disease, psychiatric condition

2. Any ongoing immune system concerns or immunodeficiency disease

3. Body mass index (BMI) changes of more than 5% over the course of the study

4. Changes in weight of more than 15 lbs. during the course of the study

5. Presence of a severe active infection as determined by the principal investigator.

6. Any other illness, disorder, alcohol or chemical dependence that in the opinion of investigators would render study participation unsuitable

7. Unable or unwilling to provide required biological sample

8. Unable or unwilling to avoid pregnancy during study period

9. Presence of cataracts before the study begins

10. Myopic changes within the first 30 days of treatment

Related Conditions & MeSH terms

• Aging

Intervention

Procedure:
• Hyperbaric Oxygen Therapy
hyperbaric oxygen therapy

Locations

Country	Name	City	State
United States	New Jersey HBOT	Florham Park	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
TruDiagnostic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Epigenetic Aging	DNA methylation of blood samples for epigenetic age	Testing will compare baseline with 6 months
Secondary	Neurotrax	Brain Care brain fitness tests follow the neuropsychological tradition by measuring: Memory, Executive Function, Attention, Visual Spatial, Verbal Function, Problem Solving, Working Memory. These tests are performed on a computer through a secure online assessment procedure. The scores on these tests are aggregated to create on measure of brain fitness	Testing will compare baseline with 6 months