BIO-CAT, a Virginia-based enzyme supplier, announced the publication of a safety manuscript supporting the use of Optiziome inulinase, marketed as Optiziome Fructanase, in Gastro Hep Advances.

The ingredient was developed to address the unintended consequences of digestive discomfort from certain foods that are high in FODMAPs (fermentable oligosaccharides, disaccharides, monosaccharides, and polyols), like vegetables, grains, and fruits. One class of these compounds commonly shared across many fruits and vegetables are fructans, which fructanase can break down.

Optiziome Fructanase is one of six fungal/microbial enzymes to enter the marketplace via New Dietary Ingredient Notification (NDIN) submitted to the U.S. Food and Drug Administration (FDA). BIO-CAT’s safety dossier on the ingredient was reviewed by GRAS Associates, a division of SGS Nutrasource, in order to ensure FDA compliance.

Fructanase was evidenced to have digestive health benefits in a phase one clinical trial, which highlighted the enzyme’s potential in reducing gastrointestinal symptoms associated with FODMAP consumption. The randomized, double-blind, placebo-controlled study involved 60 healthy participants between the ages of 20 and 65. The study, managed by SGS Nutrasource, concluded that high-dose fructanase was safe and well-tolerated with no significant differences in GI outcomes compared to placebo over a four-week period. Participants in the treatment group experienced fewer adverse events, with no notable changes in clinical parameters.

"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," said Chris Schuler, CEO of BIO-CAT.

“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,” said Lois Lin, medical writer and team lead at SGS Nutrasource. “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."