Rapid Effects on Antioxidant Status, Immune Alertness, and Regenerative Activity

NCT ID: NCT07142720

Last Updated: 2026-01-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-11-01
• Study Completion Date: 2025-07-31

Brief 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.

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: TRIPLE

Study Groups

Crossover group 1, randomized

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.

Group Type: EXPERIMENTAL

A low dose of seaweed extract

Intervention Type: DIETARY_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 extract

Intervention Type: DIETARY_SUPPLEMENT

A high dose of the seaweed extract is dissolved in plain rice milk to help camouflage the strong algae-taste.

Placebo

Intervention Type: DIETARY_SUPPLEMENT

Plain rice milk.

Crossover group 2, randomized

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.

Group Type: EXPERIMENTAL

A low dose of seaweed extract

Intervention Type: DIETARY_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 extract

Intervention Type: DIETARY_SUPPLEMENT

A high dose of the seaweed extract is dissolved in plain rice milk to help camouflage the strong algae-taste.

Placebo

Intervention Type: DIETARY_SUPPLEMENT

Plain rice milk.

Crossover group 3, randomized

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.

Group Type: EXPERIMENTAL

A low dose of seaweed extract

Intervention Type: DIETARY_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 extract

Intervention Type: DIETARY_SUPPLEMENT

A high dose of the seaweed extract is dissolved in plain rice milk to help camouflage the strong algae-taste.

Placebo

Intervention Type: DIETARY_SUPPLEMENT

Plain rice milk.

Interventions

A low dose of seaweed extract

A low dose of the seaweed extract is dissolved in plain rice milk to help camouflage the strong algae-taste.

Intervention Type: DIETARY_SUPPLEMENT

A high dose of seaweed extract

A high dose of the seaweed extract is dissolved in plain rice milk to help camouflage the strong algae-taste.

Intervention Type: DIETARY_SUPPLEMENT

Placebo

Plain rice milk.

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

Inclusion Criteria

• 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,
• 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.

Exclusion Criteria

• 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);
• 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Natural Immune Systems Inc

OTHER

Sponsor Role: lead

Responsible Party

Gitte Jensen, Ph.D.

Principal Investogator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Gitte S. Jensen, PhD

Role: PRINCIPAL_INVESTIGATOR

NIS Labs

Locations

NIS Labs

Klamath Falls, Oregon, United States

Countries

United States

Other Identifiers

176-005

Identifier Type: -

Identifier Source: org_study_id