Rapid immune-modulating effects of a nutraceutical blend

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• NIS Labs
  Klamath Falls, Oregon, United States Recruiting

Study contacts

• Principal investigator: Gitte S. Jensen, PhD — NIS Labs
• Study coordinator: Gitte S. Jensen, PhD
• Email: gitte@nislabs.com
• Phone: 15418840112

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.