Immune Surveillance
Conditions
Brief 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.
Interventions
DIETARY_SUPPLEMENTPlacebo
Four capsules.
DIETARY_SUPPLEMENTNutraceutical blend
Four capsules.
Sponsors
Natural Immune Systems Inc
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
TRIPLE (Subject, Caregiver, Investigator)
Masking description
Participants will not be informed on which intervention they consume on a given clinic visit.
Intervention model description
Double-blinded, placebo-controlled, cross-over study design.
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Immune cell surveillance | 3 hours after consuming a test product for this study protocol | Observation of changes in immune cell trafficking, i.e., the changes in immune cell numbers in the peripheral blood following administration. Data is collected as 'cell numbers per uL whole blood' for the following immune cell types: * Monocytes * NK cells * NKT cells * T cells * non-NK nonT cells |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Immune cell activation status | 3 hours after consuming a test product for this study protocol | Observation of immune cell status of alertness, i.e., the changes in the expression of CD25 and CD69. Data is collected as 'mean fluorescence intensity' for the following immune cell types: * Monocytes * NK cells * NKT cells * T cells * nonNK nonT cells |
Countries
United States
Contacts
Primary ContactGitte S. Jensen, PhD
Outcome results
None listed