Clinical Proof-of-concept Study on Rapid Immune Modulating Effects

Study Overview
=================
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.

Official Title
-----------------
Clinical Poof-of-concept Study on Rapid Immune Modulating Effects

Conditions
-----------------
Immune Surveillance

Intervention / Treatment
-----------------
* Dietary Supplement: Transfer factor from colostrum ultrafiltrate


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: Placebo-controlled, double-blinded, cross-over study design.
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group A<br>Crossover study: Participants will be consuming placebo on a clinic day at least 1 week prior to a clinic day where he/she will consume the active intervention. | Dietary Supplement: Transfer factor from colostrum ultrafiltrate<br>* Proteins that confer immune protection, isolated from cow colostrum ultrafiltrate and used to promote immune health and surveillance.<br>|
| Experimental: Group B<br>Crossover study: Participants will be consuming the active intervention on a clinic day at least 1 week prior to a clinic day where he/she will consume placebo. | Dietary Supplement: Transfer factor from colostrum ultrafiltrate<br>* Proteins that confer immune protection, isolated from cow colostrum ultrafiltrate and used to promote immune health and surveillance.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Immune communication | Observation of changes in serum cytokine levels | 2 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Immune Surveillance and Alertness | Observation of changes in immune cell trafficking and status of immune cell alertness, ie. the changes in immune cell populations and activation following administration. | 2 hours |