EpiCor® is the first immunocomplex to win the Science Excellence Award at SupplySide West (2010) and has received two Nutrition Business Journal’s Future Investment Awards (2006, 2011). What is EpiCor® and how does it affect the body? Follow the series of articles below about EpiCor® with AN Care Pharma!
1. What is EpiCor® ?
EpiCor® is a dry fermented powder produced using a non-GMO Saccharomyces cerevisiae yeast strain that undergoes anaerobic fermentation in a proprietary culture medium under stress conditions. The wet fermentation broth is dehydrated then pulverized and contains the whole inactive yeast cell including cell wall components, environmental components, along with fermentation by-products and metabolites produced during stress.
Specifically, it consists of dozens of compounds and metabolites that work together, and its biological components are a unique combination of polysaccharides, proteins and peptides, polyphenols, vitamins, amino acids, antioxidants, beta-glucans, along with other metabolites and components from the environment.
Food-grade dry fermenter is used as an ingredient in single and multi-nutrient dietary supplements and as a food contributing nutritional benefits or technical functions to enhance flavor and antioxidant properties.
Saccharomyces cerevisiae, also known as “brewer’s yeast” or “baking yeast,” is a species of budding yeast that has been used by humans for millennia as a tool for the production of foods and beverages. Baking yeast extract is considered “generally recognized as safe (GRAS) as a direct food additive.
While EpiCor® is produced by fermenting S. cerevisiae with a unique substrate production and stress process; therefore, out of an abundance of caution, this ingredient intended for human consumption has been included through a series of safety studies.
2. EpiCor® safety evaluation
EpiCor® has been shown to have a high antioxidant content and immunomodulatory properties; has significant peroxyl radical scavenging capacity in vitro based on an oxidizing radical scavenging capacity (ORAC) assay, its ability to penetrate and protect cells from oxidative damage from hydrogen peroxide which activate human natural killer (NK) cells and B cells in vitro, and has an immunomodulatory effect on polymorphonuclear cells.
In human studies, this ingredient has been shown to increase salivary IgA and hematocrit levels and be associated with immune system support associated with seasonal allergies and the incidence and duration of colds and flu.
EpiCor® is produced by fermentation from a non-GMO strain of Saccharomyces cerevisiae, therefore, concerns about the safety of natural products continue and require more detailed testing and evaluation.

a. Evaluation of mutagenicity
Several natural products that are considered antioxidants in nature such as quercetin have shown mutagenic activity in vitro and are believed to have some pro-oxidant activity. To evaluate the mutagenic effects of EpiCor®, a bacterial reverse mutagenesis assay and in vitro mammalian genomic mutation assay of murine L5178Y lymphoma cells were performed.
EpiCor® was not observed to be cytotoxic and did not increase the mutation rate at any concentration.
b. Evaluation of the ability to stimulate cell division
A number of naturally derived products and organisms have been shown to induce mitosis, leading to direct or indirect stimulation of cells causing them to divide and switch to high active state, thereby raising safety concerns and/or an overreaction of the immune system.
A lymphocyte proliferation assay divided into 2 groups: the group cultured and treated with different concentrations of EpiCor® and the group untreated. The results showed that no difference in the degree of cell division was observed between untreated and treated cells.
EpiCor® is not a lymphocyte proliferative factor.
Due to the lack of a statistically significant difference and the extent of change in any of the trials considered too small, the test material was considered to have no potential effect on genotoxicity.
c. Evaluation of oral toxicity, short and long term, acute, subchronic and chronic exposure
To further determine the safety of EpiCor®, short- and long-term oral toxicity studies included acute (14 days), subchronic (90 days) and chronic (1 year) were performed in mice.
– In a single acute oral dose study of 2000 mg/kg, 20 rats survived and no loss of body weight, clinical toxicity, or overall pathological changes were observed for 14 days.
– No deaths occurred and no treatment-related changes in general status, appearance, or behavior were observed in 160 rats given oral doses of 30, 200, and 1500 mg/kg for 90 days. No changes in visual, auditory, motor, hematological, and urine parameters were observed.
The test material was well tolerated at daily doses up to 1500 mg/kg b.w./day throughout the 90-day study period. Based on these results, the non-observable adverse event (NOAEL) level for EpiCor® was considered 1500 mg/kg b.w./day.
– There were no spontaneous deaths in 160 rats during 1 year of oral administration. Appropriate body size development corresponds to species and age in both the intervention and control groups. There were no statistically significant clinical findings for hematological, serological, urological parameters or cancer rates.
A controlled human clinical trial with an acute dose of EpiCor® showed benefits to the immune system without adverse effects, confirming previous observations that long-term exposure to this ingredient provides some protection against infectious agents.
d. Food and drug interactions with EpiCor®
Due to the potential and growing concern for food-drug interactions for natural preparations, a preliminary cytochrome P450 (CYP) induction study in vitro was performed by using immortalized human liver cells. CYP is an enzyme involved in many drug metabolism processes in the body.
The results showed that EpiCor® was not a substrate, inducer or inhibitor, affecting or interfering with the induction of 2 major CYP enzymes, CYP1A2 and CYP3A4 produced by omeprazole and rifampin in vitro.
From the data on the benefits of EpiCor®, it can be seen that an increased dose of EpiCor® is used as an ingredient in food and/or dietary supplements. Therefore, experimental studies evaluating safety need to be continued.
EpiCor® is considered safe when used in humans at appropriate doses.
References:
[1] A. G. Schauss, R. Glavits, J. Endres, G. S. Jensen, and A. Clewell, “Safety evaluation of a proprietary food-grade, dried fermentate preparation of Saccharomyces cerevisiae”, Int J Toxicol, vol. 31, no. 1 , pp. 34–45, 2012, doi: 10.1177/1091581811425195. [2] G. S. Jensen et al., “Antioxidant Bioavailability and Rapid Immune-Modulating Effects After Consumption of a Single Acute Dose of a High-Metabolite Yeast Immunogen: Results of a Placebo-Controlled Double-Blinded Crossover Pilot Study”, J Med Food, vol 14, p.h 9, p. 1002–1010, September 2011, doi: 10.1089/jmf.2010.0174.Article source: Nutrition Research and Development Institute (https://inrd.vn/)
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