Rapid Effects of a Biofield Patch on Antioxidant Status and Cellular Energy

Natural Immune Systems

Status: Enrolling

Conditions: Antioxidant Status

Treatments: Other: Placebo dermal patch; Other: Active dermal patch

Study type: Interventional

Funder types: Other

Identifiers

NCT07314359

206-003

Details and patient eligibility

About

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.

Full 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.

Enrollment: 12 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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12 participants in 2 patient groups

Experimental: Crossover group 1, randomized

Experimental group

Description:

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.

Treatment:

Other: Active dermal patch

Other: Placebo dermal patch

Experimental: Crossover group 2, randomized

Experimental group

Description:

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.

Treatment:

Other: Active dermal patch

Other: Placebo dermal patch