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Clinical Trial on Rapid Immune Modulating Effects | Clinical Trials | Clareo Health

RECRUITINGNA

Clinical Trial on Rapid Immune Modulating Effects

NCT07206407•Natural Immune Systems Inc

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.

Eligibility

Age

18 - 75 years

Sex

ALL

Healthy Volunteers

Yes

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.

Locations (1)

NIS Labs

Klamath Falls, Oregon, United States

Key Dates

Start Date

September 28, 2025

Primary Completion Date

February 1, 2026

Completion Date

March 1, 2026

Last Updated

December 17, 2025

Enrollment

ESTIMATED participants

Conditions

Immune Surveillance

Interventions

Placebo

DIETARY_SUPPLEMENT

Nutraceutical blend

DIETARY_SUPPLEMENT

Contacts

Gitte S. Jensen, PhD

CONTACT

15418840112 gitte@nislabs.com

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: December 17, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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