Rapid immune-modulating effects of a nutraceutical blend

Clinical Trial on Rapid Immune Modulating Effects

This study will test whether a nutraceutical blend changes immune cell activity within hours in healthy adults.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 24 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Natural Immune Systems Inc (Academic / other)
• Locations: 1 site (Klamath Falls, Oregon)
• Trial ID: NCT07206407 on ClinicalTrials.gov

What this trial studies

This randomized, double-blind, placebo-controlled cross-over study will give 24 healthy adults either a nutraceutical blend or placebo and measure acute immune cell responses. The active product combines low molecular weight peptides from cow colostrum ultrafiltrate, mushroom extracts, and vitamin C. Participants have a baseline blood draw after arrival, take the dose, then provide blood at 1, 2, and 3 hours post-dose with a one-week washout before crossover. The focus is on short-term changes in immune surveillance biomarkers in adults aged 18–75.

Who should consider this trial

Good fit: Ideal candidates are healthy adults aged 18–75 with easily visible veins who can follow dietary and activity restrictions and are not taking daily anti-inflammatory medications.

Not a fit: People with prior major gastrointestinal surgery, daily anti-inflammatory medication use, intensive athletic training, or severe ongoing life stressors are excluded and are unlikely to benefit from participating.

Why it matters

Potential benefit: If successful, the study could identify a safe, fast-acting nutritional approach to temporarily modify immune cell activity and guide further clinical development.

How similar studies have performed: Smaller clinical and preclinical studies suggest components like colostrum peptides, mushroom extracts, and vitamin C can alter immune markers, but rapid within-hours effects in healthy adults are sparsely studied.

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 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.

Where this trial is running

Klamath Falls, Oregon

• NIS Labs — Klamath Falls, Oregon, United States (Recruiting)

Study contacts

• Principal investigator: Gitte S. Jensen, PhD — NIS Labs
• Study coordinator: Gitte S. Jensen, PhD

Conditions Immune Surveillance