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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental: Crossover group 1, randomized | Experimental | Participants wear an active biofield patch versus a placebo patch for 12 hours on each of the two clinic days, at least 1 week apart, allowing for 1 week wash-out period between each patch. The order of interventions for this group is A, B. Following the blinded phase there will be an open-label phase where participants wear the active patch each day for 1 week until the final clinic visit. |
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| Experimental: Crossover group 2, randomized | Experimental | Participants wear a placebo patch versus an active biofield patch for 12 hours on each of the two clinic days, at least 1 week apart, allowing for 1 week wash-out period between each product. The order of interventions for this group is B, A. Following the blinded phase there will be an open-label phase where participants wear the patch each day for 1 week until the final clinic visit. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Active dermal patch | Other | Non-transdermal patch |
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| Measure | Description | Time Frame |
|---|---|---|
| Antioxidant protection | Data will be collected on intracellular levels of reduced glutathione and serum superoxide dismutase activity. | Baseline, 1 hour, and 2 hours after applying a patch. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Communication in the body via serum cytokines | Data on serum levels of 27 pro- and anti-inflammatory cytokines and regenerative growth factors will be collected. | Baseline, 1 hour, and 2 hours after applying a patch. |
| Communication in the body via cytokines in extracellular vesicles |
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:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Giite S Jensen, PhD | Contact | 5418820112 | gitte@nislabs.com | |
| Alex Cruickshank | Contact |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| NIS Labs | Recruiting | Klamath Falls | Oregon | 97601 | United States |
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Randomized, double-blinded, placebo-controlled, cross-over study design, followed by a 1-week open-label phase.
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| Placebo dermal patch | Other | Non-transdermal patch |
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| 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. | 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. |
| Baseline, 1 hour, and 2 hours after applying a patch. |