Gastrointestinal Tolerance Trials

March 2023

When developing new ingredients, such as fibers or sweeteners, or food products containing these ingredients, assessing GI tolerance is an important part of product development.

“Assessing digestibility and gastrointestinal tolerance are essential, both for product development and for consumer adoption. Clinical trials that assess the prevalence of GI symptoms after consuming a specific food or ingredient assess the tolerability of the product being studied. Validated questionnaires are used assess GI symptoms at specific intervals after consuming the test food. Since dosage is an important factor in determining tolerability, these trials often serve several doses of the product to determine an appropriate dose and corresponding level of tolerability. Once a dose has been established, longer term cumulative tolerability can then be assessed if so desired,” says Dr. Alexandra Jenkins, Senior Scientist at INQUIS. “The symptom data is compiled to determine the overall tolerability of the product being studied, which can be included in product spec sheets and informs product development and formulation efforts.”

“Finally, for selected products, further studies to establish a mechanism of action may be of interest, e.g. fermentability of a fiber. These may give an indication of possible long term health benefits.”