Immune SurveillanceNCT07142720
Rapid Effects on Antioxidant Status, Immune Alertness, and Regenerative Activity
A study testing A low dose of seaweed extract and A high dose of seaweed extract in people with Immune Surveillance and Stem Cell Surveillance, run by Natural Immune Systems Inc at 1 site in United States.
Trial summary
This clinical study aims at documenting rapid effects after consuming single doses of test product, when compared to consuming a placebo. 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
- Immune Surveillance, Stem Cell Surveillance
- What is being tested?
- A low dose of seaweed extract and A high dose of seaweed extract
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Nov 2022to 31 Jul 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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);
- Veins easy to see in one or both arms (to allow for the multiple blood draws);
- Willing to comply with a 24-hour wash-out period for vitamins and nutritional supplements;
- 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, during clinic visits.
Who cannot join
- Previous major gastrointestinal surgery (absorption of test product may be altered) (minor surgery not a problem, including previous removal of appendix and gall bladder);
- Taking anti-inflammatory medications on a daily basis;
- Currently experiencing intense stressful events/life changes;
- Currently in intensive athletic training (such as marathon runners);
- Currently taking antipsychotic medications such as clozapine, Risperdal, Abilify, Zyprexa or Seroquel;
- An unusual sleep routine (examples: working graveyard shift, irregular routine with frequent late nights, studying, partying);
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- Unwilling to maintain a constant intake of supplements over the duration of the study;
- Anxiety about having blood drawn;
- Women of childbearing potential: Pregnant, nursing, or trying to become pregnant;
- Known food allergies related to ingredients in active test product or placebo.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical Study on Rapid Effects on Antioxidant Status, Immune Alertness, and Regenerative Activity
This clinical study aims at documenting rapid effects after consuming single doses of test product, when compared to consuming a placebo.
A double-blind, placebo-controlled, cross-over study design will be used.
Read the detailed description
For each participant, the clinic visits are scheduled at the same time of the day during the morning hours of 7-11 am to control for the effect of circadian fluctuations. One clinic visit involves consuming a placebo and serves as a control for the circadian variations in cytokine levels and immune surveillance for each participant. Since there is interference from exercise and stress with the release versus homing of lymphocytes, the study environment is managed so that any physical and mental stress is minimized during each visit. Upon arrival at a clinic visit, participants complete a questionnaire to help monitor exceptional circumstances that may influence the stress level of that person on that day. Predetermined criteria for re-scheduling a visit include sleep deprivation and acute anxiety. After completing the questionnaire, participants are instructed to remain calm and inactive for 3 hours, comfortably seated in a chair. After the first hour, the baseline blood sample is drawn. Immediately after the baseline sample is drawn, a test product is provided and consumed in the presence of clinic staff. Blood samples are drawn at 1 hour and 2 hours after consumption of the test product or placebo.
The blood is tested for antioxidant status, immune cell surveillance, and regenerating properties involving stem cell surveillance. The process of surveillance is the natural process of our immune and stem cells to move through our body and detect problems that need repair. In addition, blood samples are tested for changes to pro- and anti-inflammatory cytokines, antiviral peptides, and restorative growth factors.
- Conditions
- Immune Surveillance, Stem Cell Surveillance
- Being tested
- A low dose of seaweed extract, A high dose of seaweed extract, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
A low dose of seaweed extractDietary supplement
A low dose of the seaweed extract is dissolved in plain rice milk to help camouflage the strong algae-taste.
A high dose of seaweed extractDietary supplement
A high dose of the seaweed extract is dissolved in plain rice milk to help camouflage the strong algae-taste.
PlaceboDietary supplement
Plain rice milk.
| Study group | Role | What they receive |
|---|---|---|
| Crossover group 1, randomized | Experimental | Crossover study: Participants consume a test product on each of the three clinic days, at least 1 week apart, allowing for 1 week wash-out period between each product. Participants will consume each of the 2 doses of the active test product versus placebo over 3 weeks. The order of interventions for this group is placebo, low dose, high dose. Receives: Dietary Supplement: A low dose of seaweed extract; Dietary Supplement: A high dose of seaweed extract; Dietary Supplement: Placebo |
| Crossover group 2, randomized | Experimental | Crossover study: Participants consume a test product on each of the three clinic days, at least 1 week apart, allowing for 1 week wash-out period between each product. Participants will consume each of the 2 doses of the active test product versus placebo over 3 weeks. The order of interventions for this group is low dose, high dose, placebo. Receives: Dietary Supplement: A low dose of seaweed extract; Dietary Supplement: A high dose of seaweed extract; Dietary Supplement: Placebo |
| Crossover group 3, randomized | Experimental | Crossover study: Participants consume a test product on each of the three clinic days, at least 1 week apart, allowing for 1 week wash-out period between each product. Participants will consume each of the 2 doses of the active test product versus placebo over 3 weeks. The order of interventions for this group is high dose, placebo, low dose. Receives: Dietary Supplement: A low dose of seaweed extract; Dietary Supplement: A high dose of seaweed extract; Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Antioxidant uptake and protection
Changes to antioxidant status of blood samples
Measured: 1 and 2 hours
Secondary outcomes (1)
Immune cell numbers in blood
Changes to immune cell trafficking and status of immune cell alertness, ie. the changes in immune cell populations and activation following consumption: Numbers of CD3- CD56+ NK cells in blood Numbers of CD3+ CD56+ NKT cells in blood Numbers of CD3+ CD56- T cells in blood Numbers of cells positive for CD25 Numbers of cells positive for CD69
Measured: 1 and 2 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2025
- Study start1 Nov 2022
- Primary completion31 Jan 2024
- Study completion31 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Immune SurveillanceStudies 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
- Placebo-controlled, double-blinded, cross-over study design.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Natural Immune Systems Inc
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gitte Jensen, Ph.D., Natural Immune Systems Inc
- Investigators
- Gitte S. Jensen, PhD, Principal investigator, NIS Labs
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07142720
- Sponsor's protocol ID
- 176-005
- Status last verified
- Jan 2026
- First submitted
- 13 Aug 2025
- Last updated
- 30 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 30 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study on Rapid Effects on Antioxidant Status, Immune Alertness, and Regenerative Activity
- ClinicalTrials.gov ID
- NCT07142720
- Acronym / sponsor ID
- 176-005
- Conditions
- Immune Surveillance, Stem Cell Surveillance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Natural Immune Systems IncUniversity, hospital or other
- Study start
- 1 Nov 2022 (actual)
- Primary completion
- 31 Jan 2024 (actual)
- Study completion
- 31 Jul 2025 (actual)
- First posted
- 27 Aug 2025 (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.
This clinical study aims at documenting rapid effects after consuming single doses of test product, when compared to consuming a placebo.
A double-blind, placebo-controlled, cross-over study design will be used.
Detailed description
For each participant, the clinic visits are scheduled at the same time of the day during the morning hours of 7-11 am to control for the effect of circadian fluctuations. One clinic visit involves consuming a placebo and serves as a control for the circadian variations in cytokine levels and immune surveillance for each participant. Since there is interference from exercise and stress with the release versus homing of lymphocytes, the study environment is managed so that any physical and mental stress is minimized during each visit. Upon arrival at a clinic visit, participants complete a questionnaire to help monitor exceptional circumstances that may influence the stress level of that person on that day. Predetermined criteria for re-scheduling a visit include sleep deprivation and acute anxiety. After completing the questionnaire, participants are instructed to remain calm and inactive for 3 hours, comfortably seated in a chair. After the first hour, the baseline blood sample is drawn. Immediately after the baseline sample is drawn, a test product is provided and consumed in the presence of clinic staff. Blood samples are drawn at 1 hour and 2 hours after consumption of the test product or placebo.
The blood is tested for antioxidant status, immune cell surveillance, and regenerating properties involving stem cell surveillance. The process of surveillance is the natural process of our immune and stem cells to move through our body and detect problems that need repair. In addition, blood samples are tested for changes to pro- and anti-inflammatory cytokines, antiviral peptides, and restorative growth factors.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 3
- Model description
- Placebo-controlled, double-blinded, cross-over study design.
| Arm | Type | Receives |
|---|---|---|
| Crossover group 1, randomized | Experimental | Dietary Supplement: A low dose of seaweed extract, Dietary Supplement: A high dose of seaweed extract, Dietary Supplement: PlaceboCrossover study: Participants consume a test product on each of the three clinic days, at least 1 week apart, allowing for 1 week wash-out period between each product. Participants will consume each of the 2 doses of the active test product versus placebo over 3 weeks. The order of interventions for this group is placebo, low dose, high dose. |
| Crossover group 2, randomized | Experimental | Dietary Supplement: A low dose of seaweed extract, Dietary Supplement: A high dose of seaweed extract, Dietary Supplement: PlaceboCrossover study: Participants consume a test product on each of the three clinic days, at least 1 week apart, allowing for 1 week wash-out period between each product. Participants will consume each of the 2 doses of the active test product versus placebo over 3 weeks. The order of interventions for this group is low dose, high dose, placebo. |
| Crossover group 3, randomized | Experimental | Dietary Supplement: A low dose of seaweed extract, Dietary Supplement: A high dose of seaweed extract, Dietary Supplement: PlaceboCrossover study: Participants consume a test product on each of the three clinic days, at least 1 week apart, allowing for 1 week wash-out period between each product. Participants will consume each of the 2 doses of the active test product versus placebo over 3 weeks. The order of interventions for this group is high dose, placebo, low dose. |
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);
- Veins easy to see in one or both arms (to allow for the multiple blood draws);
- Willing to comply with a 24-hour wash-out period for vitamins and nutritional supplements;
- Willing to comply with study procedures, including:
Key exclusion criteria (10 listed)
- Previous major gastrointestinal surgery (absorption of test product may be altered) (minor surgery not a problem, including previous removal of appendix and gall bladder);
- Taking anti-inflammatory medications on a daily basis;
- Currently experiencing intense stressful events/life changes;
- Currently in intensive athletic training (such as marathon runners);
- Currently taking antipsychotic medications such as clozapine, Risperdal, Abilify, Zyprexa or Seroquel;
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 |
|---|---|---|
| A low dose of seaweed extractA low dose of the seaweed extract is dissolved in plain rice milk to help camouflage the strong algae-taste. | Dietary supplement | Crossover group 1, randomized, Crossover group 2, randomized, Crossover group 3, randomized |
| A high dose of seaweed extractA high dose of the seaweed extract is dissolved in plain rice milk to help camouflage the strong algae-taste. | Dietary supplement | Crossover group 1, randomized, Crossover group 2, randomized, Crossover group 3, randomized |
| PlaceboPlain rice milk. | Dietary supplement | Crossover group 1, randomized, Crossover group 2, randomized, Crossover group 3, randomized |
Primary outcome
Antioxidant uptake and protection
Time frame: 1 and 2 hours
Changes to antioxidant status of blood samples
1 secondary outcome
Immune cell numbers in blood
Time frame: 1 and 2 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 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. This study is not recruiting at the moment.
Gitte S. Jensen, PhD principal investigator
NIS Labs
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing A low dose of seaweed extract and A high dose of seaweed extract in people with Immune Surveillance and Stem Cell Surveillance, 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 10 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: finished, as of the sponsor's last update on 30 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Antioxidant uptake and protection (time frame: 1 and 2 hours). 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 30 Jan 2026; AzTrials last refreshed its copy on 6 Nov 2026.