New Human Trials Confirm Strong Immune-Modulating Actions
By VRP Staff
EpiCor® has emerged as a powerful immune-modulating natural agent. Past articles in this newsletter have explored EpiCor’s novel ability to help regulate the human body’s natural immune defenses, illustrated by its ability to increase CD4 (helper) and decrease CD8 (suppressor) cells. This leads to an up regulation of natural defenses as the direct consequence of the CD4 cells increasing immunological responsiveness. EpiCor also enhances activity of natural killer (NK) cells, which are crucial in defending the body against viruses and invading organisms.

Recently, scientists have conducted a number of human studies on EpiCor. Although these studies are currently being written for publication and have not yet appeared in a medical journal, we wanted to give our readers a first-hand glimpse of the study results. Once the studies are published, upcoming issues of this newsletter will provide a more in-depth look at these trials.

Human Clinical Trials

The gold standard for research in the dietary supplement industry is the human clinical trial. Three human studies were conducted using EpiCor. These showed a strong trend toward its ability to support a balanced immune system with dosage amounts of only 500 mg per day over several weeks. The studies focused on the immune system’s ability to help lessen the duration and symptoms of a cold or flu, as well as reduce the problems associated with seasonal allergies. Furthermore, a recent animal study demonstrates the antioxidant properties of EpiCor (see side bar).

Study #1 Strengthening the Body’s Immunological Envelope

The first human clinical trial aimed to prove that EpiCor would provide the same effects in humans as it does in animals, but with smaller doses of EpiCor. The study was comprised of 22 people who had neither been exposed to nor taken EpiCor. The participants were given small doses of 500 mg per day over a period of weeks. Saliva samples were taken twice a day, three times a week, for a month, and saliva secretory IgA was measured to establish the baseline concentration.

IgA, or Immunoglobulin A, is an antibody and, in its secretory form (sIgA), is the main antibody found in mucous secretions including tears, saliva, and other bodily secretions. Because it is resistant to degradation by enzymes, it can survive harsh environments such as the digestive and respiratory tracts, to provide protection against microbes that multiply in body secretions, acting as a protective immunological envelope around mucous membranes.

The subjects of this study were given one 500 mg capsule of EpiCor per day for 60 more days, and the sIgA monitoring was continued. After 30 days, there was a strong trend for increased sIgA over baseline, and after 60 days the average sIgA levels among the subjects were significantly higher than the baseline levels. This indicates that EpiCor increased this important immune defense component in just a matter of a few weeks.

Study #2 Seasonal Allergy and Immune Support

Another human clinical trial investigated the effects of EpiCor on several markers of immune function. In this double-blind, placebo-controlled trial, subjects were given either EpiCor (1,000 mg) or placebo for 5 weeks. At the end of 5 weeks, the salivary sIgA increased while the serum IgE decreased. Though not reaching full statistical significance due to the nature of this pilot trial, this was a strong trend. These results helped confirm the findings of the previous trial supporting the efficacy of EpiCor. On the other hand, the decreased serum IgE suggests the important immune balancing effects of EpiCor.

Antioxidant Properties of EpiCor®
EpiCor has been shown to have one of the highest antioxidant activities of any known fruit, including blueberries, black raspberries, strawberries and cranberries, making it a potent weapon against cell-damaging free radicals that result from cellular metabolism and toxic exposure.

Once it was discovered that EpiCor contained a variety of antioxidant nutrients, studies were conducted to measure its free radical scavenging potential. Toward this end, isolated human neutrophil cells (phagocytic white blood cells that “gobble up” viral and pathogenic invaders) were exposed to hydrogen peroxide, a potent oxidizing agent. The exposure to hydrogen peroxide constituted an extreme oxidative stress due to the formation of radical oxygen species (ROS). Compared to cells exposed only to hydrogen peroxide, those exposed to both the peroxide and a one part per trillion dilution of EpiCor showed a statistically significant inhibition of ROS formation. This inhibition continued at increasingly larger dilutions of EpiCor, down to 0.01 parts per trillion.

EpiCor’s antioxidant abilities may account for its anti-inflammatory effects, which were further demonstrated in two rodent trials. In one rat trial researchers induced paw swelling in the animals with carrageenan (an irritant that can act as an inflammatory agent) and in another study they induced arthritis with collagen. In both cases there was a statistically significant reduction in inflammation in rats consuming EpiCor.

Since this trial was conducted in the spring when allergies are a problem for many people, one would expect serum IgE to increase, since this immune parameter is associated with allergies. This was seen in the controls. However, in the EpiCor group, the levels stayed nearly at baseline, giving laboratory confirmation of the subjects’ reporting fewer allergy problems than usual. This was also reflected in a standardized questionnaire showing fewer health complaints with the EpiCor group. It was also observed that cytokine profiles were shifting in the EpiCor group—from Th1 (pro-inflammatory) to Th2 (pro-adaptive) and vice versa—again demonstrating the immune balancing properties of EpiCor.

Study #3 Upper Respiratory Tract Health

Last, a third study assessed the clinical benefits of EpiCor in a large, independently conducted double-blind, placebo-controlled human clinical trial. To do this, 230 people were recruited to take either EpiCor or placebo, to study the effects on upper respiratory tract infections (URTI). This large group was chosen to represent the general population aged 18 years and older. The trial took place during the worst cold and flu months—January, February and March—in South Dakota. Subjects received physical examinations at screening to ensure a healthy study population, and were randomly assigned to receive either EpiCor or placebo. Fasting blood samples were taken at randomization, week 6 and at week 12 (when the trial ended). Each subject was given a diary and instructed to record duration and severity of cold and flu symptoms.

In the subjects taking EpiCor, the incidence of URTIs was statistically and significantly reduced. A statistic known as the “p-value” was 0.0000008—meaning that the probability that the reduction in URTIs in the EpiCor group occurred by chance was less than one in a million. Additionally, in the rare cases when the EpiCor subjects did get URTIs, the duration of the symptoms was significantly shorter.

Conclusion

These three soon-to-be published human clinical trials support the body of past research that establishes EpiCor as a means to support immune health. In these studies, EpiCor showed a strong trend toward supporting a balanced immune system with smaller dosage amounts than that given to animals. These results demonstrate that EpiCor may have a strong role to play in optimizing immune health.

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