TROY,
Va., July 11, 2024 /PRNewswire/ -- 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.
BIO-CAT is excited to announce the
publication of a safety clinical trial manuscript featuring
OPTIZIOME® Fructanase.
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.
About BIO-CAT, Inc.
Founded in 1988, BIO-CAT provides innovative enzyme technologies
and custom blending. BIO-CAT's extensive range of products, from
single and multi-enzyme formulations to
OPTIZIOME® branded solutions, serve various
dietary supplement, food, agriculture, and industrial markets.
BIO-CAT maintains an FSSC 22000 certified facility in Virginia, featuring state-of-the-art
laboratories for scientific research, product development, and
on-site quality testing. OPTIZIOME® is a
registered trademark of BIO-CAT, Inc.
For more information on OPTIZIOME® Fructanase, contact
corporateaffairs@bio-cat.com.
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https://health.osu.edu/wellness/exercise-and-nutrition/should-you-be-avoiding-fructans
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SOURCE BIO-CAT, INC.