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

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.

Study Overview

• Status: Recruiting
• Conditions: Antioxidant Status
• Intervention / Treatment: Other: Active dermal patch; Other: Placebo dermal patch

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.

• Study Type: Interventional
• Enrollment (Estimated): 12
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Alex Cruickshank
• Study Contact Backup: Name: Giite S Jensen, PhD; Phone Number: 5418820112; Email: gitte@nislabs.com

Study Locations

• United States
  • Oregon
    • Klamath Falls, Oregon, United States, 97601
      • Recruiting
      • NIS Labs
      • Contact: Gitte S Jensen, PhD; Phone Number: 5418820112; Email: Gitte@nislabs.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental: Crossover group 1, randomized; 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.	Other: Active dermal patch; Non-transdermal patch; Other: Placebo dermal patch; Non-transdermal patch
Experimental: Experimental: Crossover group 2, randomized; 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.	Other: Active dermal patch; Non-transdermal patch; Other: Placebo dermal patch; Non-transdermal patch

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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.

Secondary Outcome Measures

Outcome Measure	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.	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

Other Outcome Measures

Outcome Measure	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	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.

Collaborators and Investigators

• Sponsor: Natural Immune Systems Inc

Study record dates

Study Major Dates

• Study Start (Actual): December 4, 2025
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): August 1, 2026

Study Registration Dates

• First Submitted: November 30, 2025
• First Submitted That Met QC Criteria: December 17, 2025
• First Posted (Estimated): January 2, 2026

Study Record Updates

• Last Update Posted (Estimated): January 2, 2026
• Last Update Submitted That Met QC Criteria: December 17, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: Cytokines; Mitochondria; Glutathione; Superoxide dismutase activity
• Other Study ID Numbers: 206-003

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No