BIO-CAT Announces Groundbreaking Safety Study on New Enzyme Addressing High FODMAP Foods
TROY, Va. — In a significant breakthrough for the dietary supplement industry, BIO-CAT, the Virginia-based enzyme supplier, has unveiled the results of a landmark safety clinical trial for their latest innovation, OPTIZIOME® Fructanase. This pioneering enzyme, focused on improving digestive health, has been spotlighted in a newly published manuscript in Gastro Hep Advances, marking a major stride in the nutrition and wellness sectors.
Developed to combat the uncomfortable digestive side effects caused by high FODMAP foods, OPTIZIOME® Fructanase (originally marketed as OPTIZIOME® Inulinase) is engineered to specifically target fructans. Fructans, a type of FODMAP found abundantly in certain vegetables, grains, and fruits, are known to trigger digestive discomfort in numerous individuals. By breaking down fructans, this enzyme presents a promising remedy for those affected by such dietary challenges.
The significance of BIO-CAT’s latest advancement cannot be overstated. OPTIZIOME® Fructanase has distinguished itself within the dietary supplement landscape by becoming one of a select few fungal and microbial enzymes over the last decade to receive a New Dietary Ingredient Notification (NDIN) from the FDA. Underpinned by a comprehensive safety dossier reviewed and approved by GRAS associates of SGS Nutrasource (Guelph, Ontario, Canada), this recognition underscores the enzyme’s compliance with the highest FDA safety standards.
The efficacy and safety profile of OPTIZIOME® Fructanase were rigorously tested in a Phase I clinical trial. The study, a randomized, double-blind, placebo-controlled endeavor involving 60 healthy participants aged 20-65, was managed and conducted by Nutrasource. It yielded conclusive evidence that high-dose supplementation of fructanase is both safe and well-tolerated over a 4-week period, without significant gastrointestinal outcomes compared to a placebo. Additionally, the fructanase group reported fewer adverse events, with no notable changes in clinical parameters, showcasing the supplement’s potential benefits in reducing FODMAP-induced digestive symptoms.
“As consumer trends continue to evolve towards healthier dietary choices, including the incorporation of high FODMAP foods, addressing the accompanying digestive discomfort becomes paramount,” said Chris Schuler, CEO of BIO-CAT. Schuler expressed enthusiasm about the enzyme’s development, viewing it as a direct response to growing market demands for dietary digestive solutions.
The successful completion and publication of the clinical trial on microbial fructanase underline BIO-CAT’s committed effort to spearhead innovative solutions in digestive health. This achievement not only represents a significant collaborative triumph but also cements BIO-CAT’s role as a pioneer in the development of enzyme technology aimed at enhancing consumers’ well-being.
Founded in 1988, BIO-CAT continues to lead the way in the provision of advanced enzyme solutions. With a robust product lineup ranging from single and multi-enzyme formulations to specialized OPTIZIOME® branded solutions, BIO-CAT caters to diverse markets including dietary supplements, food, agriculture, and industry sectors. Operating from an FSSC 22000 certified facility in Virginia, the company is equipped with advanced laboratories for in-depth scientific research, product development, and stringent quality testing, ensuring that each product meets the highest standards of efficacy and safety.
