NCT07142720

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: Natural Immune Systems Inc · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Accepted

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

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	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.
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.
DIETARY_SUPPLEMENT	Placebo	Plain rice milk.

Timeline

• Start date: 2022-11-01
• Primary completion: 2024-01-31
• Completion: 2025-07-31
• First posted: 2025-08-27
• Last updated: 2026-01-30

Locations

1 site across 1 country: United States