Antioxidant StatusNCT07314359
Rapid Effects of a Biofield Patch on Antioxidant Status and Cellular Energy
A study testing Active dermal patch in people with Antioxidant Status, run by Natural Immune Systems Inc at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Antioxidant Status
- What is being tested?
- Active dermal patch
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Dec 2025to Aug 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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,
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- 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.
Who cannot join
- 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);
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- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Alex Cruickshank contact
United States1 site, 1 recruiting
- Recruiting
NIS Labs
Klamath Falls, Oregon, 97601
Gitte S Jensen, PhD, 5418820112, Gitte@nislabs.com
About this study
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.
Read the 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.
- Conditions
- Antioxidant Status
- Being tested
- Active dermal patch, Placebo dermal patch
- Keywords
- Superoxide dismutase activity, Glutathione, Mitochondria, Cytokines
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Active dermal patchOther
Non-transdermal patch
Placebo dermal patchOther
Non-transdermal patch
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Active dermal patch; Other: Placebo dermal patch |
What is being measured
The primary outcome is the main question the study is designed to answer.
Antioxidant protection
Data will be collected on intracellular levels of reduced glutathione and serum superoxide dismutase activity.
Measured: Baseline, 1 hour, and 2 hours after applying a patch.
Secondary outcomes (2)
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.
Measured: 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.
Measured: Baseline, 1 hour, and 2 hours after applying a patch
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jan 2026
- Study start4 Dec 2025
- Primary completionJul 2026 (estimated)
- Study completionAug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Antioxidant StatusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Randomized, double-blinded, placebo-controlled, cross-over study design, followed by a 1-week open-label phase.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Natural Immune Systems Inc
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07314359
- Sponsor's protocol ID
- 206-003
- Status last verified
- Dec 2025
- First submitted
- 30 Nov 2025
- Last updated
- 2 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Rapid Effects of a Biofield Patch on Antioxidant Status and Cellular Energy
- ClinicalTrials.gov ID
- NCT07314359
- Acronym / sponsor ID
- 206-003
- Conditions
- Antioxidant Status
- Keywords
- Superoxide dismutase activity, Glutathione, Mitochondria, Cytokines
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- Natural Immune Systems IncUniversity, hospital or other
- Study start
- 4 Dec 2025 (actual)
- Primary completion
- Jul 2026 (estimated)
- Study completion
- Aug 2026 (estimated)
- First posted
- 2 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized, double-blinded, placebo-controlled, cross-over study design, followed by a 1-week open-label phase.
| Arm | Type | Receives |
|---|---|---|
| Experimental: Crossover group 1, randomized | Experimental | Other: Active dermal patch, Other: Placebo dermal patchParticipants 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: Crossover group 2, randomized | Experimental | Other: Active dermal patch, Other: Placebo dermal patchParticipants 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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:
Key exclusion criteria (13 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Active dermal patchNon-transdermal patch | Other | Experimental: Crossover group 1, randomized, Experimental: Crossover group 2, randomized |
| Placebo dermal patchNon-transdermal patch | Other | Experimental: Crossover group 1, randomized, Experimental: Crossover group 2, randomized |
Primary outcome
Antioxidant protection
Time frame: Baseline, 1 hour, and 2 hours after applying a patch.
Data will be collected on intracellular levels of reduced glutathione and serum superoxide dismutase activity.
2 secondary outcomes
Mitochondrial volume per cell
Time frame: Baseline, 1 hour, and 2 hours after applying a patch.
Mitochondrial membrane potential per cell
Time frame: Baseline, 1 hour, and 2 hours after applying a patch
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jan 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Alex Cruickshank contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Active dermal patch in people with Antioxidant Status, run by Natural Immune Systems Inc at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 2 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Giite S Jensen, PhD (5418820112, gitte@nislabs.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Antioxidant protection (time frame: Baseline, 1 hour, and 2 hours after applying a patch.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jan 2026.