Aging
Conditions
Brief summary
This study aims to assess the impact of hyperbaric oxygen therapy on a number of outcomes, including epigenetic aging, inflammation, and cellular health.
Detailed 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.
Interventions
PROCEDUREHyperbaric Oxygen Therapy
hyperbaric oxygen therapy
Sponsors
TruDiagnostic
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Masking description
Participants, the principal investigator, and outcomes assessor will be blinded to patient's HBOT dosing. Technicians at the clinic will know which treatment dose each participant is receiving in order to deliver appropriate dosing.
Intervention model description
The control group will crossover to active treatment after 3 months of observation.
Eligibility
Sex/Gender
ALL
Age
40 Years to 70 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Epigenetic Aging | Testing will compare baseline with 6 months | DNA methylation of blood samples for epigenetic age |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Neurotrax | Testing will compare baseline with 6 months | 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 |
Countries
United States
Outcome results
None listed