Clinical Trial on Rapid Immune Modulating Effects

Not Applicable

Not yet recruiting

• Conditions: Immune Surveillance

• Registration Number: NCT07206407
• Lead Sponsor: Natural Immune Systems Inc

Brief Summary

The goal for this clinical trial is to document rapid effects of a nutritional blend on immune cells. A double-blind, placebo-controlled, cross-over study design will be used.

Detailed Description

Clinical trial comparing the acute immune effects of a nutraceutical blend, and a placebo. The nutraceutical blend is based on low molecular weight peptides isolated from cow colostrum ultrafiltrate, mushroom extracts, and vitamin C.

24 subjects will participate in a placebo-controlled, randomized, double-blinded, cross-over study design, wherein they will be consuming placebo or the active nutraceutical blend, separated by a 1-week washout period.

Baseline blood samples are taken 1 hour after participants arrive; the dose is then administered. Additional blood samples are taken 1 hour, 2 hours, and 3 hours following consumption of test product.

Study Timeline

• Status Verified: 2025-09
• Study First Submitted: 2025-09-10
• Study First Submitted QC: 2025-09-25
• Last Update Submitted: 2025-09-25
• Study Start: 2025-09-28
• Study First Posted: 2025-10-03
• Last Update Posted: 2025-10-03
• Primary Completion: 2026-02-01
• Study Completion: 2026-03-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 24

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 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;
• Pregnant, nursing, or trying to become pregnant;
• Known allergies related to ingredients in active test product or placebo.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
Immune cell surveillance	3 hours after consuming a test product for this study protocol	Observation of changes in immune cell trafficking, i.e., the changes in immune cell numbers in the peripheral blood following administration. Data is collected as 'cell numbers per uL whole blood' for the following immune cell types: * Monocytes; * NK cells; * NKT cells; * T cells; * non-NK nonT cells

Secondary Outcome Measures

Name	Time	Method
Immune cell activation status	3 hours after consuming a test product for this study protocol	Observation of immune cell status of alertness, i.e., the changes in the expression of CD25 and CD69. Data is collected as 'mean fluorescence intensity' for the following immune cell types: * Monocytes; * NK cells; * NKT cells; * T cells; * nonNK nonT cells

Trial Locations

Locations (1)

NIS Labs; 🇺🇸 Klamath Falls, Oregon, United States