Immune Surveillance
Conditions
Brief summary
Clinical-proof-of concept study, comparing the acute immune impacts of of 2 doses of a novel blend of supplements to a placebo. This study involves twenty-four participants, composed of healthy adults, who will be taking a placebo and 2 different doses of the blend at different times. Testing for immune status and cytokine levels will be conducted to determine the acute impact of the blend on immune function as compared to the placebo.
Detailed description
Clinical-proof-of-concept study comparing the acute immune effects of 2 doses of a nutraceutical blend, and a placebo. The nutraceutical blend is based on a transfer factor isolated from cow colostrum ultrafiltrate. 24 subjects will participate in a placebo-controlled, randomized, double-blinded, cross-over study design, wherein they will be taking placebo, dose 1, and dose 2, each separated by a 1-week washout period. Blood samples are taken 1 hour after participants arrive; the dose is then administered. Samples are taken 1 hour, 2 hours, and 24 hours following administration. At each blood sample collection, a spit sample will also be taken for salivary IgA testing. A series of immune panels will be used to determine the acute impacts on immune surveillance, immune cell activation status, immune cell priming, and cytokine profiles.
Interventions
DIETARY_SUPPLEMENTTransfer factor from colostrum ultrafiltrate
Proteins that confer immune protection, isolated from cow colostrum ultrafiltrate and used to promote immune health and surveillance.
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 receive on any given day.
Intervention model description
Placebo-controlled, double-blinded, cross-over study design.
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
Yes
Inclusion criteria
* Healthy adults * Veins easy to see in one or both arms * Willing to comply with study procedures, including * Maintaining a consistent diet and lifestyle routine throughout the study; * Consistent habit of bland breakfast on days of clinic visits * Abstaining from exercising on 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 * Taking anti-inflammatory medications on a daily basis * Currently experiencing intense stressful events/life changes * Currently in intensive athletic training (such as marathon runner) * Currently taking antipsychotic medications such as clozapine, Risperdal, Abilify, Zyprexa or Seroquel * An unusual sleep routine * Unwilling to maintain a constant intake of supplements over the duration of the study * Anxiety about having blood drawn * People of childbearing potential: Pregnant, nursing, or trying to become pregnant * Known food sensitivities related to ingredients in active test product placebo Prescription medication evaluated on a cas-by-case basis
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Immune communication | 2 hours | Observation of changes in serum cytokine levels |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Immune Surveillance and Alertness | 2 hours | Observation of changes in immune cell trafficking and status of immune cell alertness, ie. the changes in immune cell populations and activation following administration. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Immune responsiveness | 2 hours | Ex vivo immune challenges, observing the capabilities of anti-bacterial and anti-viral defenses. Additionally, mucosal immune protection as determined by salivary IgA, defensins, and transferrin changes. |
Countries
United States
Outcome results
None listed