Actively Recruiting
Clinical Trial on Rapid Immune Modulating Effects Using a Nutraceutical Blend Compared to Placebo in Healthy Adults
Led by Natural Immune Systems Inc · Updated on 2025-12-17
24
Participants Needed
1
Research Sites
4 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the immediate effects of a nutritional blend on immune cells in a healthy adult population. This clinical trial uses a double-blind, placebo-controlled, cross-over design to compare the immune responses after consuming a nutraceutical blend versus a placebo. The nutraceutical blend contains low molecular weight peptides from cow colostrum ultrafiltrate, mushroom extracts, and vitamin C. Participants will consume either the active nutraceutical blend or a placebo in two separate clinic visits spaced at least one week apart to allow a washout period. Each dose consists of four capsules taken during each visit. The study design randomizes participants to receive the interventions in different orders to assess the rapid immune effects. During each visit, baseline blood samples are collected one hour after arrival, followed by administration of the test product. Additional blood samples are drawn one, two, and three hours after consumption to monitor immune cell surveillance and activation status. The total duration of participation spans approximately two weeks, including the washout period between visits. The study focuses on measuring immune cell changes three hours after product intake.
CONDITIONS
Brief Title
Clinical Trial on Rapid Immune Modulating Effects
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Healthy adults
- Age 18 to 75 years (inclusive)
- Veins easy to see in one or both arms to allow multiple blood draws
- Willing to maintain consistent diet and lifestyle throughout the study
- Willing to have bland breakfasts on days of clinic visits
- Agree to abstain from exercise and nutritional supplements on study visit mornings
- Agree to abstain from coffee, tea, and soft drinks for at least one hour before visits
- Agree to abstain from music, candy, gum, and computer/cell phone use during clinic visits
You will not qualify if you...
- Previous major gastrointestinal surgery (minor surgeries like appendix or gall bladder removal allowed)
- Daily use of anti-inflammatory medications
- Experiencing intense stressful events or life changes
- Engaged in intensive athletic training (e.g., marathon running)
- Taking antipsychotic medications such as clozapine, Risperdal, Abilify, Zyprexa, or Seroquel
- Having an unusual sleep routine (e.g., night shifts, irregular late nights)
- Unwilling to maintain a constant intake of supplements during the study
- Anxiety about blood draws
- Pregnant, nursing, or trying to become pregnant
- Known allergies to ingredients in the active test product or placebo
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 2 weeks
Participants consume either the nutraceutical blend or placebo on two separate clinic visits. Blood samples are collected before and multiple times after each dose to assess immune effects. Visits are separated by a 1-week washout period.
2 visits (in-person), each including multiple blood draws over 3 hours
Trial Site Locations
Total: 1 location
1
NIS Labs
Klamath Falls, Oregon, United States, 97601
Actively Recruiting
Research Team
G
Gitte S. Jensen, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
BASIC_SCIENCE
Number of Arms
2
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here