Isoflavone Stability, Quality Control Assessment and Clinical Safety of Q-CAN® Plus, a Novel Fermented Beverage

Abstract

There is substantial data that fermented products have a diverse range of health benefits ranging from immunomodulation, improving lipid profiles and more recently positive effects on the microbiome. Despite these desirable clinical attributes there are practical barriers to the use of fermented products. Two such barriers are that many studies were performed using experimental products, and lacked careful characterization of content, stability, toxicology and safety. To overcome these issues, we identified a widely available fermented product (BESO Q-CAN® Plus) and i) conducted independent analysis of total isoflavone content, aerobic bacteria, yeast and mold plate counts, quantification of heavy metals, solvents, and ii) performed a safety clinical trial in 10 lean and 10 obese healthy subjects who consumed Q-CAN® Plus for 4 weeks, with a further 8 week follow-up. Q-CAN® Plus had 120.9 mg/100 ml of total isoflavones. Bacteria, mold, yeast were all below the normal limits. A profile of 300 herbicides, pesticides, fungicides and solvents was negative. Lead, mercury, arsenic and cadmium were below the detectable limit. A 24-month stability study demonstrated no decrease in the concentration of isoflavones and no microbiological contamination. The clinical trial demonstrated that Q-CAN® Plus was well tolerated. This independent analysis of Q-CAN® Plus demonstrated a stable isoflavone content, absence of a wide range of potential toxins and stability over 24 months. Q-CAN® Plus was also well tolerated. These data provide the information required for the safe use of an easily available fermented soy product.