The randomized, double-blind, placebo-controlled, cross-over clinical trial is the first human clinical trial of the enzyme combination, Sean Garvey, PhD, Bio-Cat’s director of R&D, told us.
The trial will examine a mixture of six fungal enzymes or placebo over three weeks in participants aged 50 to 75. Study outcomes include changes in gastrointestinal symptoms, bowel function, and sleep quality between BC-006 and placebo. More details can be found at ClinicalTrials.gov.
The study’s principal investigator (PI) is Dr. Nicholas Burd, an expert in protein metabolism. Dr Burd, who previously served as lead PI on 14 clinical research studies, is Associate Professor in the Department of Kinesiology & Community Health at UIUC, as well as Director of the Nutrition and Exercise Performance Research Group.
“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.
The UIUC Institutional Review Board-approved clinical trial is aiming to enroll 30 participants to receive either the enzyme blend, called BC-006, or a placebo twice a day with meals for three weeks. This will be followed by a "washout" period of at least one week without any supplementation before the participants cross over to the other group for a further three weeks.
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.
Chris Schuler, CEO of Bio-Cat, commented: “At Bio-Cat, we're always on the lookout for ways to stay at the forefront of enzyme innovation. 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.”
Dr Garvey said that the final and 30th study participant is expected to complete the study by October, at which time the UIUC team will begin analyzing 780 plasma samples and over 8,000 responses to daily GI symptom questions.
“Our goal is to submit a manuscript in time to share peer-reviewed results no later than March 2023,” he said.
Commenting on the enzyme combination, Dr Garvey explained that the BC-006 digestive enzyme blend contains 6 different fungal enzyme preparations, all sourced from non-genetically engineered microbes.
“The proprietary blend includes 3 different proteases to support digestion of dietary protein across both the stomach and upper intestine, as well as lipase to support fat digestion, and amylase and glucoamylase to support carbohydrate digestion,” he said.
“We built BC-006 as a foundational module for digestive support, to which additional enzymes and functional ingredients can be added. In addition to testing the impact of BC-006 on fundamental macronutrient digestion in the clinic, the UIUC team will also test whether daily supplementation at home for 3 weeks can impact the frequency and severity of GI symptoms such as flatulence, burping, and bloating in older adults.”