BIO-CAT, an industry-leading enzyme supplier headquartered in Virginia, is excited to announce the publication of a groundbreaking safety clinical trial manuscript featuring its proprietary ingredient, OPTIZIOME® Inulinase (now marketed as OPTIZIOME® Fructanase), in Gastro Hep Advances.
Fructanase, also known as inulinase, was developed to address the unintended consequences of digestive discomfort from certain foods, more specifically foods high in FODMAPs (fermentable oligosaccharides, disaccharides, monosaccharides, and polyols), including certain vegetables, grains, and fruits. Notably, many vegetables and fruits contain a specific FODMAP called fructans which cause digestive discomfort1. Fructanase is an enzyme which breaks down fructans, offering potential solutions for digestive health.
BIO-CAT’s OPTIZIOME® Fructanase has reached new heights within the dietary supplement industry as one of only 6 other fungal and microbial enzymes within the past decade to be granted a New Dietary Ingredient Notification (NDIN) from the FDA. BIO-CAT’s rigorous safety dossier on OPTIZIOME® Fructanase was reviewed by GRAS associates, a division of SGS Nutrasource (Guelph, Ontario, Canada), ensuring compliance with FDA standards. According to the FDA, an NDIN must provide evidence supporting the safety of a new dietary ingredient under recommended conditions of use.
The efficacy of OPTIZIOME® Fructanase was demonstrated in a Phase I clinical trial, which showcased its safety profile and potential in reducing gastrointestinal symptoms associated with FODMAP consumption. The trial was conducted as a randomized, double-blind, placebo-controlled study with 60 healthy participants aged 20–65 years.
The study, managed by Nutrasource, yielded promising results. It concluded that high-dose fructanase supplementation was safe and well tolerated, with no significant differences in GI outcomes compared to placebo over a 4-week period. Moreover, participants in the fructanase group experienced fewer adverse events, with no notable changes in clinical parameters.
Chris Schuler, CEO of BIO-CAT, emphasizes the company’s dedication to addressing these challenges: “All market indicators point towards consumers seeking healthier meal options, including high FODMAP dietary choices. As a company focused on digestive health, we understand the challenges consumers could face. I’m excited that the team was able to bring a new enzyme application to our customers and partners that addresses the growth of high FODMAP foods.”
Lois Lin, Medical Writer and Team Lead at SGS Nutrasource, says “We are delighted to congratulate BIO-CAT on the successful completion and publication of their clinical trial for microbial fructanase, a novel enzyme to aid the digestion of hard-to-digest fibers. This milestone is a testament to the collaborative efforts of the dedicated research teams, investigators, and study participants. At SGS Nutrasource, we are proud to have played a vital role in the design and conduct of this clinical trial, and look forward to BIO-CAT’s continued progress in bringing this novel enzyme to the market.”
BIO-CAT remains committed to advancing digestive health solutions through innovative enzyme technologies, with OPTIZIOME® Fructanase poised to make a significant impact on consumer well-being.
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