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

NCT07314359 | Recruiting

• 1 other identifier: 206-003
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Antioxidant Status

Keywords

Superoxide dismutase activity; Glutathione; Mitochondria; Cytokines

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Mitochondrial volume per cell

  Baseline, 1 hour, and 2 hours after applying a patch.

• Mitochondrial membrane potential per cell

  Baseline, 1 hour, and 2 hours after applying a patch

Other Outcomes (2)

• Communication in the body via serum cytokines

  Baseline, 1 hour, and 2 hours after applying a patch.

• Communication in the body via cytokines in extracellular vesicles

  Baseline, 1 hour, and 2 hours after applying a patch.

Study Arms (2)

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.

Other: Active dermal patch; Other: Placebo dermal patch

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.

Other: Active dermal patch; Other: Placebo dermal patch

Interventions

Active dermal patch OTHER

Non-transdermal patch

Experimental: Crossover group 1, randomized; Experimental: Crossover group 2, randomized

Placebo dermal patch OTHER

Non-transdermal patch

Experimental: Crossover group 1, randomized; Experimental: Crossover group 2, randomized

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Natural Immune Systems Inc: lead

Study Sites (1)

NIS Labs

Klamath Falls, Oregon, 97601, United States

RECRUITING

Central Study Contacts

Giite S Jensen, PhD

CONTACT

5418820112; gitte@nislabs.com

Alex Cruickshank

CONTACT

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized, double-blinded, placebo-controlled, cross-over study design, followed by a 1-week open-label phase.

Study Record Dates

• First Submitted: November 30, 2025
• First Posted: January 2, 2026
• Study Start: December 4, 2025
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): August 1, 2026
• Last Updated: January 2, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)