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

NCT07142720 | Completed

• 1 other identifier: 176-005
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Stem Cell Surveillance; Immune Surveillance

Outcome Measures

Primary Outcomes (1)

• Antioxidant uptake and protection

  Changes to antioxidant status of blood samples

  1 and 2 hours

Secondary Outcomes (1)

• Immune cell numbers in blood

  1 and 2 hours

Other Outcomes (2)

• Stem Cell Numbers in Blood

  1 and 2 hours

• Communication through cytokines.

  1 and 2 hours

Study Arms (3)

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.

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.

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.

Dietary Supplement: A low dose of seaweed extract; Dietary Supplement: A high dose of seaweed extract; Dietary Supplement: Placebo

Interventions

A low dose of seaweed extract DIETARY_SUPPLEMENT

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

Crossover group 1, randomized; Crossover group 2, randomized; Crossover group 3, randomized

A high dose of seaweed extract DIETARY_SUPPLEMENT

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

Crossover group 1, randomized; Crossover group 2, randomized; Crossover group 3, randomized

Placebo DIETARY_SUPPLEMENT

Plain rice milk.

Crossover group 1, randomized; Crossover group 2, randomized; Crossover group 3, 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);
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Natural Immune Systems Inc: lead

Study Sites (1)

NIS Labs

Klamath Falls, Oregon, 97601, United States

Location

Study Officials

• Gitte S. Jensen, PhD

  NIS Labs

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: Participants will not be informed on which intervention they receive on any given day.
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investogator

Model Details: Placebo-controlled, double-blinded, cross-over study design.

Study Record Dates

• First Submitted: August 13, 2025
• First Posted: August 27, 2025
• Study Start: November 1, 2022
• Primary Completion: January 31, 2024
• Study Completion: July 31, 2025
• Last Updated: January 30, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)