Rapid Effects of a Biofield Patch on Antioxidant Status and Cellular Energy
ConditionAntioxidant Status
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorNatural Immune Systems Inc
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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);
Disqualifiers
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);
Trial design
Design model
Crossover
Treatments tested in this trial
Active dermal patch
Other interventionNon-transdermal patch
Placebo dermal patch
Other interventionNon-transdermal patch
Treatment groups
12 Participants
are divided into 2 treatment groupsGroup A: Experimental: Crossover group 1, randomizedExperimental treatment 2 interventions
Group B: Experimental: Crossover group 2, randomizedExperimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
Antioxidant 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.Secondary outcomes
1
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.2
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 patchOther outcomes
1
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.
Time frame
Baseline, 1 hour, and 2 hours after applying a patch.2
Communication in the body via cytokines in extracellular vesicles
Data on the levels of 27 pro- and anti-inflammatory cytokines and regenerative growth factors in serum extracellular vesicles will be collected.
Time frame
Baseline, 1 hour, and 2 hours after applying a patch.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov