Antioxidant Status
Conditions
Keywords
Superoxide dismutase activity, Glutathione, Mitochondria, Cytokines
Brief summary
The goal for this clinical proof-of-concept study is to compare an active biofield skin patch to a placebo patch on antioxidant function and mitochondrial function. A double-blind, placebo-controlled cross-over study design will be used.
Detailed description
The goal for this clinical proof-of-concept study is to document acute effects of a photobiomodulating non-transdermal patch compared to a placebo patch, in an acute randomized double-blind placebo-controlled cross-over design. An add-on open-label module involves wearing the active patch daily for a week before the final clinic visit. Data on endogenous antioxidant protection will be collected. The testing will show whether wearing the patch leads to a change in antioxidant activity of superoxide dismutase and glutathione. Data on cellular energy production and mitochondrial resilience in white blood cells under oxidative and inflammatory stress ex vivo will be collected. This testing will show whether using the active patch leads to changes in mitochondrial biogenesis and mitochondrial energy production under normal versus ex vivo-stressed conditions. Data on serum cytokine levels in both serum and serum-derived extracellular vesicles will be collected. The testing will show whether wearing the patch contributes to rapid change in pro- and anti-inflammatory markers and restorative growth factors.
Interventions
OTHERActive dermal patch
Non-transdermal patch
OTHERPlacebo dermal patch
Non-transdermal patch
Sponsors
Natural Immune Systems Inc
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Intervention model description
Randomized, double-blinded, placebo-controlled, cross-over study design, followed by a 1-week open-label phase.
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
Yes
Inclusion criteria
* Healthy adults; * Age 18 - 75 years (inclusive); * BMI between 18.0 and 34.9 (inclusive); * Veins easy to see in one or both arms (to allow for the multiple blood draws); * Willing to comply with study procedures, including: * Maintaining a consistent diet and lifestyle routine throughout the study, * Consistent habit of bland breakfasts on days of clinic visits, * Abstaining from exercising and nutritional supplements on the morning of a study visit, * Abstaining from use of coffee, tea, and soft drinks for at least one hour prior to a clinic visit; * Abstaining from music, candy, gum, computer/cell phone use (airplane mode is allowed), during clinic visits.
Exclusion criteria
* Cancer during past 12 months; * Chemotherapy during past 12 months; * Currently taking prescription weight loss drugs (such as semaglutide); * Currently taking cholesterol-lowering medication (for example: statins); * Currently experiencing intense stressful events/life changes; * Currently in intensive athletic training (such as marathon runners); * Currently taking anxiolytic, hypnotic, or anti-depressant prescription medication; * Immunization during past 6 months; * An unusual sleep routine (examples: working graveyard shift, irregular routine with frequent late nights, studying, partying); * Unwilling to maintain a constant intake of supplements over the duration of the study; * Anxiety about having blood drawn; * Pregnant, nursing, or trying to become pregnant; * Known allergies related to adhesive materials.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Antioxidant protection | Baseline, 1 hour, and 2 hours after applying a patch. | Data will be collected on intracellular levels of reduced glutathione and serum superoxide dismutase activity. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mitochondrial volume per cell | Baseline, 1 hour, and 2 hours after applying a patch. | Mitochondrial volume per cell, measured by flow cytometry where the mean fluorescence intensity (MFI) is quantified on lymphocytes, monocytes, and polymorphonuclear cells. White blood cells are purified and cultured ex vivo in unstressed versus inflamed culture conditions. The mitochondrial reporter dye MitoTracker is used to obtain relative measures of mitochondrial volume per cell. |
| Mitochondrial membrane potential per cell | Baseline, 1 hour, and 2 hours after applying a patch | Cellular energy production as a function of the mitochondrial membrane potential where the mean fluorescence intensity (MFI) is quantified on lymphocytes, monocytes, and polymorphonuclear cells. White blood cells are purified and cultured ex vivo in unstressed versus inflamed culture conditions. The mitochondrial reporter dye JC-1 is a fluorescent cationic dye used to obtain relative measures of mitochondrial membrane potential per cell. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Communication in the body via serum cytokines | Baseline, 1 hour, and 2 hours after applying a patch. | Data on serum levels of 27 pro- and anti-inflammatory cytokines and regenerative growth factors will be collected. |
| Communication in the body via cytokines in extracellular vesicles | Baseline, 1 hour, and 2 hours after applying a patch. | Data on the levels of 27 pro- and anti-inflammatory cytokines and regenerative growth factors in serum extracellular vesicles will be collected. |
Countries
United States
Contacts
Primary ContactGiite S Jensen, PhD
Backup ContactAlex Cruickshank
Outcome results
None listed