Clinical Trial on Rapid Immune Modulating Effects
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Placebo, Nutraceutical blend.
- Who it may be relevant to
- Registry conditions: Immune Surveillance. Basic parameters: 18 years — 75 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Interventions
- Dietary supplement Placebo
Four capsules. - Dietary supplement Nutraceutical blend
Four capsules.
Primary outcome measures
- Immune cell surveillance [Time frame: 3 hours after consuming a test product for this study protocol]
Secondary outcome measures (1)
- Immune cell activation status [Time frame: 3 hours after consuming a test product for this study protocol]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Crossover
- Masking
- Triple blind
- Primary purpose
- Basic science
Study locations
United States · 1 center
- NIS Labs — Klamath Falls
Identifiers
NCT: NCT07206407 · 058-010