BIO-CAT, Inc. – a Virginia-based biotech company specializing in enzyme production and development – has announced the launch of a clinical trial at the University of Illinois at Urbana-Champaign (UIUC) that is investigating the efficacy of a digestive enzyme blend that aims to improve protein digestion and gastrointestinal tolerance.
The UIUC Institutional Review Board-approved clinical trial – sponsored by BIO-CAT – will examine a mixture of six fungal enzymes – referred to as BC-006 – and their use as a dietary supplement for older adults.
“As one of the largest enzyme distributors in the US, we have a duty to innovate and substantiate,” BIO-CAT Director of R&D Sean Garvey said. “We’re bringing new, advanced clinical science to old enzymes, and UIUC has a great team in place to test how well the BC-006 enzyme blend can promote digestive health.”
In this randomized, double-blind, placebo-controlled, cross-over clinical trial, participants aged 50 to 75 will take either the BC-006 supplement or a placebo twice a day with meals for three weeks. Following a “washout” period of at least one week without any supplementation, participants will repeat the process so that each participant will have consumed each of BC-006 and placebo for three weeks. Study outcomes include changes in gastrointestinal symptoms, bowel function, and sleep quality between BC-006 and placebo.
Additionally, at the end of each three week period, participants will return to the clinic to undergo a mixed meal tolerance test. In this test, participants will consume a meal consisting of chicken, green peas, and potatoes. Participants will have blood drawn just before the meal and throughout five hours after the meal. Blood samples will be analyzed for amino acids, fats, glucose, and iron to test whether the enzyme blend can increase blood nutrient levels after a meal better than placebo.
Protein metabolism expert Dr. Nicholas Burd is the principal investigator (PI) for the study. He is Associate Professor in the Department of Kinesiology & Community Health at UIUC, as well as Director of the Nutrition and Exercise Performance Research Group. Dr. Burd has previously served as lead PI on 14 clinical research studies.
“We are looking forward to beginning the new clinical trial with BIO-CAT. The opportunity to test the efficacy of a digestive enzyme blend provides exciting possibilities of improving the current understanding around digestive health. Being that many individuals struggle with gastrointestinal-related issues, the practical implications are wide-reaching,” Burd shared.
Additionally, Dr. Hannah Holscher, Associate Professor in the Department of Food Science & Human Nutrition at UIUC, joins the study team as co-investigator.
BIO-CAT’s sponsorship of the UIUC clinical study is part of a continued industry and academic focus on the increasingly popular topic of malnutrition and dietary protein intake in older adults.
“At BIO-CAT, we’re always on the lookout for ways to stay at the forefront of enzyme innovation,” BIO-CAT CEO Chris Schuler added. “We hope this trial can be a huge step toward promoting optimal nutrition and digestion-related issues in older adults. We can’t wait to see the results.”
UIUC is actively recruiting participants in the Urbana-Champaign, Illinois area to take part in the digestive health research study. For more information, view the trial registration at ClinicalTrials.gov: https://clinicaltrials.gov/ct2/show/NCT05211440
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