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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
QUADRUPLE
Enrollment
12
Non-transdermal patch
Non-transdermal patch
NIS Labs
Klamath Falls, Oregon, United States
RECRUITINGAntioxidant protection
Data will be collected on intracellular levels of reduced glutathione and serum superoxide dismutase activity.
Time frame: Baseline, 1 hour, and 2 hours after applying a patch.
Mitochondrial volume per cell
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.
Time frame: Baseline, 1 hour, and 2 hours after applying a patch.
Mitochondrial membrane potential per cell
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.
Time frame: Baseline, 1 hour, and 2 hours after applying a patch
Alex Cruickshank
CONTACT
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