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

Natural Immune Systems Inc24 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

TRIPLE

Enrollment

Conditions

Immune Surveillance

Interventions

Transfer factor from colostrum ultrafiltrateDIETARY_SUPPLEMENT

Proteins that confer immune protection, isolated from cow colostrum ultrafiltrate and used to promote immune health and surveillance.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

NIS Labs

Klamath Falls, Oregon, United States

RECRUITING

Outcomes

Primary Outcomes

Immune communication

Observation of changes in serum cytokine levels

Time frame: 2 hours

Secondary Outcomes

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.

Time frame: 2 hours

Data from ClinicalTrials.gov

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