Enzyme supplement may safely offer gastrointestinal FODMAP support

Data published in Gastro Hep Advances​ indicated that four weeks of consumption of Bio-Cat’s Optiziome Fructanase with meals was not associated with any safety concerns. Indeed, participants in the placebo group reported twice the number of adverse events than people in the enzyme group.

“Altogether, microbial inulinase supplementation is an attractive, candidate stop-gap approach to restoring some of the intestinal metagenomic carbohydrate-active enzyme functionality that has waned since the dawn of modern agriculture, processed foods and low-fiber diets,” wrote researchers from Bio-Cat Inc. and Nutrasource.

FODMAP​

FODMAP refers to fermentable oligosaccharides, disaccharides, monosaccharides and polyols. The ingredients are not digested but draw water while they pass through the small intestine and produce gas as they are fermented by the gut bacteria in the large intestine, causing bloating and other uncomfortable symptoms in susceptible people, particularly people with Irritable Bowel Syndrome (IBS).

High FODMAP foods include dairy products containing lactose, fruits and sweeteners high in fructose, onions, garlic, and some beans and vegetables.

Some prebiotics are a particularly troublesome category for people with IBS because the most common prebiotics like inulin are FODMAPs.

Study details​

Bio-Cat developed Fructanase to address the unintended consequences of digestive discomfort from certain foods, more specifically foods high in FODMAPs. The enzyme ingredient is one of only six other fungal and microbial enzymes within the past decade to be granted a New Dietary Ingredient Notification (NDIN) from the FDA, according to a press release from Bio-Cat.

The company, working with Canada-based Nutrasource, examined the effects of its Optiziome Fructanase ingredient in a Phase I clinical trial, which included 60 healthy participants between the ages of 20 and 65.

The randomized, double-blind, placebo-controlled study yielded “promising results,” said Bio-Cat, with a total daily dose of 2,000 inulinase activity units (INU) found to be safe and well tolerated, with no significant differences in GI outcomes over the 4-week period.

The researchers noted that the study included healthy adults with no diagnosed GI issues and they did not expect to see any differences between the groups in terms of GI symptoms, and that is indeed what was observed.

“Further research is warranted to assess whether microbial inulinase supplementation can reduce fructan malabsorption, GI symptoms and intestinal inflammation in individuals with FODMAP sensitivity and IBS, perhaps also in combination with other FODMAP-targeting enzymes such as alpha-galactosidase,” they added.

Commenting on the significance of the study, Chris Schuler, CEO of BIO-CAT, said: "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."

Source: Gastro Hep Advances​
doi: 10.1016/j.gastha.2024.05.013​
"Safety and Tolerability of Microbial Inulinase Supplementation in Healthy Adults: A Randomized, Placebo-Controlled Trial"
Authors: S.M. Garvey, et al.