Clinical trial NCT05297019: A Dosing Study of Hyperbaric Oxygen Therapy (HBOT) on Epigenetic Aging
Official title: Hyperbaric Dosage Analysis Effect Of Various PO2 Exposures: Hyperoxia-Hypoxia Paradox On Stem Cell Mobilization, Cell Signaling, Inflammation, Epigenetics & Cell Regeneration
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
PHASE3
Conditions: Aging
Lead sponsor: TruDiagnostic
Sponsor class: INDUSTRY
First posted: 2022-03-25
Enrollment: 30
Sex: ALL
Minimum age (years): 40
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: The "control" group will crossover to active treatment after 3 months of observation.
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Eligibility criteria: 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

Primary outcomes:
measure: Epigenetic Aging
timeFrame: Testing will compare baseline with 6 months
Secondary outcomes:
measure: Neurotrax
timeFrame: Testing will compare baseline with 6 months
Other outcomes:
Locations:
city: Florham Park
country: United States
facility: New Jersey HBOT
state: New Jersey
Study officials:
References: