Recruiting

Biofield Patch

Sponsor:

Natural Immune Systems Inc

Code:

NCT07314359

Conditions

Antioxidant Status

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

Interventions

Active dermal patch

Placebo dermal patch

Study Details

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

Study ID

NCT07314359

Start date

Dec 4, 2025

Status verified date

Dec, 2025

Completion date

Aug, 2026

Anticipated

Primary completion date

Jul, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

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 Design

Enrollment

12 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Basic Science

Interventions and Outcome Measures

Arms

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.

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.

Interventions

Active dermal patch

Non-transdermal patch

Placebo dermal patch

Non-transdermal patch

Primary outcome measure

  • Antioxidant protection [ Time Frame: Baseline, 1 hour, and 2 hours after applying a patch. ]

Central Contacts and Locations

Central contacts

Giite S Jensen, PhD

5418820112gitte@nislabs.com

Locations

NIS Labs

Recruiting

Klamath Falls, Oregon, United States, 97601

Contacts

Gitte S Jensen, PhD

5418820112Gitte@nislabs.com

More Information

Sponsor

Natural Immune Systems Inc

Last update posted

Jan 2, 2026

Last verified

Dec, 2025

Keywords

  • Superoxide dismutase activity
  • Glutathione
  • Mitochondria
  • Cytokines

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Natural Immune Systems Inc on 2026-01-02.