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EpiCor™
Novel
Immune System Enhancer Strengthens Microbial and Mutagenic Defense
By Chris D. Meletis, ND
Immunity is one of the body's most important resources. Yet some
of the most devastating diseases can affect this aspect of our
health, including HIV, cancer, and autoimmune diseases such as
rheumatoid arthritis, lupus, and multiple sclerosis. Even if we're
not subject to any of these chronic conditions, we can become
vulnerable to a host of influenza viruses or bacterial infections. It's therefore integrally important to reinforce our immune systems.
Over the last three years, some of the top laboratories in the nation
have been researching a substance that appears to modulate the
immune system in such a way as to make it resistant to pathogenic
organisms. After personally communicating with the director of the
research team responsible for investigating this new substance, I
have concluded that it is one of the most promising agents I've
seen. However, before I describe its discovery and how it supports
the immune system, I must describe several key aspects of our
bodies' immune defenses.
One of the ways we can nurture this aspect of health is to enhance
the activity of natural killer cells, key players in immunity. Natural killer cells are lymphocytes, cells present in the blood and
lymphatic tissue that are integral to immunity. Natural killer cells
bond to viral-invaded cells and release cytotoxins that kill the
infected cells. They act similarly on many types of tumor cells.
While natural killer cells are an important aspect of immunity, they
are not the only aspect. The immune system is a complex tapestry
that also relies upon the proper functioning of T-cells. These cells
emerge from the bone marrow in an immature state and must migrate to
the thymus gland, where they are programmed to transform into:
-
CD4 helper cells, which orchestrate the immune response by
activating other immune cells and stimulating the production of
antibodies by the B- cells.
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CD8 suppressor cells, which suppress killer cells by signaling
the termination of an attack.
Therefore, if we could find a natural substance that decreases the
number of CD8 suppressor cells in relation to the number of CD4
helper cells, we would improve the CD4/CD8 ratio, strengthening the
ability of the immune system to defend against viral, bacterial, and
parasitical invaders.
A third aspect of immunity involves immunoglobulin A (IgA). IgA is
the principal immunoglobulin in exocrine secretions. It is important
in protecting mucosal surfaces from invasion by pathogenic bacteria
and viruses. Its presence in colostrum is thought to be the main
reason behind colostrum's anti-infective properties in newborns.
While the aforementioned aspects of immunity are important, they
are, in a sense, oversimplifying how the immune system works, as it
is a complex interplay of many different factors. However,
understanding each of the factors I mention above will help explain
how the new discovery discussed below has a novel and fascinating
effect on the immune system. Accidental Discovery
The discovery of a unique yeast-derived product called EpiCor™ began
when insurance adjusters noticed that employees of a leading
manufacturer of animal nutrition products, experienced unusually low
sick leave rates and filed significantly fewer claims than employees
of similarly sized companies. In fact, while 2004 annual insurance
premiums increased an average of 11.2 percent nationally, this
company's 2004 premiums didn't increase at all.
The owners suspected this low illness rate was due to a fermented
yeast culture the company manufactured for production animals, since
the workers who came in contact with this fermented yeast culture
experienced an unusual lack of illnesses.
Consequently, the company commissioned a research group to perform a
series of studies investigating EpiCor's effects, its safety, and
whether it was the agent responsible for the enhanced immunity at
the company's production facility plant.
Prior to conducting these studies, the research group visited the
manufacturing facility and interviewed the employees. They began
with the plant manager, who had previously worked at another company
for more than 20 years. His wife was an emergency room nurse and
often caught viral infections while on the job. While working at the
other company, the plant manager and his children contracted 3 to 5
colds or flus per year. However, he had now worked with the
fermented yeast product for 9 years and had not had a cold or flu
for at least the last 7 years. His wife and children continued to
contract a number of illnesses every year.
After hearing similar stories from other members of the production
facility staff, the researchers were intrigued. Among the production
facility workers, there had been no admissions for any emergency
room visits, no incidence of any chronic diseases. In the
administrative building, where employees rarely came in contact with
the fermented yeast product, there was a greater incidence of colds
and flu.
There definitely seemed to be a reason to investigate this product.
Background on EpiCor
The ingredient to be investigated was an end product of fermentation
of baker’s yeast (Saccharomyces cerevisiae). The company has
produced this product for 63 years as an additive to animal feed
products, and they distribute it worldwide.
The process used to manufacture the product, while not patented, is
a trade secret that other large companies have failed to replicate.
Consequently, EpiCor's producer has dominated in the feed
marketplace for many years, especially since it wasn't uncommon for
animals consuming the animal feed version of EpiCor to have an
increased litter size compared to what would normally be expected.
Antioxidant Powerhouse
First, the team of researchers broke down EpiCor's composition to
help determine why it might have an immunomodulating effect. In
doing this, it was noted that EpiCor had an excellent profile of
mono unsaturated and polyunsaturated fatty acids and a small amount
of saturated fat. In addition, all of the essential vitamins and
minerals were in the product as well as trace elements.
Interestingly, they also found it contained compounds known to exert
free-radical-fighting activity such as phytosterols and phenolics,
including catechins and trans-resveratrol. The researchers were
surprised to find compounds such as squalene, which is found in
sharks and only a very few plant species. Given this profile of
substances known to exert antioxidant activity, they decided to
subject EpiCor to studies investigating its antioxidant potential.
The first study conducted was designed to determine whether EpiCor
could inhibit the formation of radical oxygen species (ROS) in
freshly purified human neutrophil cells. They exposed the cells to
hydrogen peroxide to induce severe oxidative stress then compared
the EpiCor-treated cells to the cells left untreated. They
discovered significant reduction of all ROS formation at EpiCor
concentrations as low as 1 part per trillion compared to control
cells challenged with only hydrogen peroxide. They continued to
observe inhibition of ROS formation at concentrations even lower
than one part per trillion. This effect didn't stop until they
reached a concentration of 0.01 part per trillion. The antioxidant
activity of EpiCor (or ORAC activity, as it's called in the industry)
was actually significantly greater than that of blueberries.
Microbial Studies
Next, the researchers found that EpiCor dramatically reduced the
growth of E. coli bacteria and Candida tropicalis. At concentrations
that continued all the way down to 1 part per billion, they noted
total inhibition of E. coli and Candida tropicalis. It did not,
however, inhibit Staphylococcus aureus.
After conducting this study, they concluded that EpiCor may provide
protection against infection with coliform bacteria (a common cause
of food poisoning) and Candida. The study also indicated that EpiCor
may support the growth of desirable mucosal flora in the intestinal
tract. Stability and Toxicity Studies
The research team also decided to conduct a study to determine if
EpiCor had a sufficient shelf life, an important consideration if it
were to be consumed by humans. They first determined that when the
product sat at 77 degrees Fahrenheit for 28 days, levels of mold,
Salmonella, and Staphylococcus aureus stayed below the acceptable
limit. Other tests have shown that it is extremely stable for at
least 22 months.
In another study, they asked a leading lab to check for 139
different pesticides. EpiCor was found free of all 139 compounds
tested for at the detection limits.
They also performed oral toxicity studies in rats. They gave 2,000
mg of EpiCor per kg of body weight to 20 rats—the equivalent to 140
grams administered orally in humans. After 14 days, the animals
treated with EpiCor had normal body weights, and no deaths occurred
during the treatment period. In addition, no gross pathological
changes were observed.
In a 90-day toxicity study, they treated 4 groups of rats (40
animals per group) with either 30, 200 or 1,500 mg of EpiCor per kg
of body weight. A fourth group served as the control. EpiCor-treated
rats did not have an increased rate of mortality, there were no
treatment-related clinical symptoms, no significant differences in
body weight, nor any pathological changes in any areas examined. In
addition, there were no gross pathological lesions found in any
organs.
The researchers concluded that EpiCor was well tolerated in daily
oral doses up to 1,500 mg for 90 days. (A 90-day rodent study is
equivalent to 1.5 years of human consumption in a 70 kg adult male
or a 50 kg adult female).
Other tests have shown that EpiCor is not mutagenic and does not
have the potential to cause gene mutation.
Before delving into human studies, they also investigated whether
EpiCor is contraindicated in people taking any type of
pharmaceutical drug. So they looked at whether it would affect
drug-metabolizing enzymes such as Cytochrome P450. They conducted a
test called the immortalized human hepatocyte assay, considered the
gold standard for inducing drug-metabolizing enzymes. Through this
test, they found that EpiCor is not toxic, does not induce the
expression or enzymatic activity of cytochrome P450 or other drug
metabolizing enzymes, and therefore does not interfere in drug
metabolism. Human Studies
They were almost ready to conduct human studies on EpiCor's
immuno-modulating potential. However, first they wanted to ensure
its safety. For one month, 15 men and women ages 15–40 consumed
500 mg of EpiCor in a single daily dose. They measured baseline
values for the 3 days preceding the study’s start. Multiple blood samples
were taken on Days 2 and 28, and additional blood and saliva samples
on Days 0, 14, 21, 28. EpiCor was well tolerated, with no evidence of
adverse effects on the immune system nor any clinically relevant
changes to any vital signs.
Now that they had determined that EpiCor is safe, non-toxic,
non-mutagenic, is not harmful to cells, and is pesticide-free, they
were ready to begin studying if and how it affects immunity in
humans. They compared one group of 10 production employees who are
exposed to EpiCor on the job at the facility with another group of
10 gender and age-matched non-production facility employees not
exposed to EpiCor.
They analyzed blood samples, and what they found was fascinating. The
group exposed to EpiCor showed a significant decrease in CD8
suppressor cells, resulting in an improvement in the CD4/CD8 ratio.
The CD4/CD8 ratio suggested that these EpiCor-exposed individuals
had at least 2 to 3 times the natural killing activity against
viruses, bacteria, and cancer cells than would normally be expected!
This was quite striking to the laboratory. The director called one
of the researchers and said, "I've never seen anything like these
results before. These people seem virtually immune from contracting
almost anything."
The researcher then asked the director to go through the results and
highlight the ones he thought were significant, while the researcher
did the same. They did not hold the code as to whose blood samples
they were observingl; the code was still kept by a scientist at the
facility. But when they broke the code, they had both 100 percent
successfully separated the production from the non-production
employees based on their immune profile.
One of the other interesting aspects is that natural killer cells in
EpiCor-exposed subjects had a much higher killing efficiency of
pathogen-infected and abnormal cells, despite a significant decrease
in the natural killer cells' number. To use an analogy, if we sent
out soldiers, we could send out fewer soldiers because they had
become more efficient at doing battle. At the same time,
EpiCor-exposed subjects experienced a significant inhibition of
interferon gamma production, which indicates that EpiCor has
anti-inflammatory abilities.
They also found significantly higher levels of total salivary
secretory IgA in the EpiCor subjects. The IgA levels were
surprisingly high—more than 300 mg per ml. This indicated that the
EpiCor subjects had the equivalent of an immunological envelope
protecting all the membranes in the eyes, nasal passages, and all
the places where pathogenic organisms enter into the system.
They also found significantly lower levels of immune complexes and
higher levels of glutathione in erythrocytes (red blood cells). Higher levels of immune complexes are responsible for inflammation,
and lowering their levels would result in less inflammation and
tissue damage.
These same immune-modulating effects were seen in the study
mentioned earlier in this article, in the 15 subjects treated with
EpiCor for 28 days. Calcium Signaling
Another aspect of the EpiCor studies worth mentioning is known as
calcium signaling. Calcium signaling between cells is pivotal to the
coordinated response of cells in tissues and organs within the whole
body. It is now well-established that cells do not behave as selfish
entities, but rather tend to form "micro-societies" whose proper
functioning requires a precise coordination of signals that the
cells emit and receive. When these signals are not working properly,
this can result in pathological situations that can range from
abnormal cell proliferation to cell death. The research has shown
that EpiCor can influence calcium signaling, thereby offering a
potential explanation for how EpiCor supports immunity and defends
against invading pathogens.
Additionally, it was determined that EpiCor affects the activity of
Nuclear Factor Kappa B (NFK-B). NFK-B plays an important role in
inflammation, immunity, autoimmune responses, cell adhesion, cell
proliferation, cell development, and cell death (apoptosis), because
it regulates the expression of genes involved in all these
processes. GRAS Status
After conducting these studies, an expert panel of toxicologists was
assembled to review the data. The panel was chaired by the former
director of the division of drugs and environmental toxicology and
the human food safety program at the FDA. Other panelists included
EPA scientists and the editor of the journal Food and Chemical
Toxicology. As a result of the panel review, EpiCor has now received
FDA’s Generally Recognized as Safe (GRAS) classification. Conclusion
I have never been so impressed by the effects of a compound as I
have been with EpiCor. At this writing, there is one published study
depicting the immune-modulating aspects of EpiCor:
Schauss, AG,
Vodjani, A. Discovery of an edible fermentation product with
unusual immune-enhancing properties in humans. FASEB J. 2006;
20(4): A143.
Because this information is so new, a majority of studies mentioned
in this article are still unpublished. The researchers expect
to submit five manuscripts to peer-reviewed journals within the next
six months. Meanwhile, the confirmed safety of EpiCor and its
effects on various immune parameters indicate that it is an
immune-modulating substance par excellence. Chris Meletis, ND
Dr. Chris D. Meletis is an educator, international author and
lecturer. Dr. Meletis has authored 14 books and was awarded the 2003
naturopathic physician of the year by the American Association of
Naturopathic Physicians. He has also written over 200 nationally
published health and wellness articles. He served as Chief Medical
Officer and Dean of Naturopathic Medicine for the National College
of Naturopathic Medicine and has participated in starting 16 clinics
providing care for uninsured families.
His personal mission is "Changing America’s Health One Person at a
Time." He believes that when people become educated about their
health that this is when true wellness is achieved.
The information in this article is not intended to provide
personal medical advice, which should be obtained from a medical
professional, and has not been approved by the U.S. FDA.
Copyright by Vitamin Research Products, Inc.
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