The Effects of Oral Fructanase Administration on Gastrointestinal Symptoms After Inulin Challenge in Healthy Adults

Summary

The carbohydrate inulin (from chicory root) is a healthy prebiotic ingredient found in dietary supplements and fortified foods (Nagy et al). Inulin is representative of a broader class of typically health-associated, yet fermentable carbohydrates called fructans that occur naturally in many vegetables, fruits, and wheat. Fructans, or long chains of fructose units, are resistant to human digestive enzyme hydrolysis and transit intact to the small intestine and colon where they undergo rapid fermentation by intestinal microbes. This microbial metabolism of fructans produces gas and other fermentation byproducts that can lead to excess gastrointestinal (GI) symptoms like abdominal bloating, cramping, stomach rumbling, and flatulence (Bonnema et al; Briet et al; Bruhwyler et al), especially in individuals with irritable bowel syndrome (Van den Houte et al). A new digestive enzyme called fructanase was developed to help with GI symptoms associated with fructan consumption. Positive findings from in vitro digestion simulations (Guice et al) and a first-in-human safety trial (Garvey et al) helped define the fructanase dose for this clinical trial-the primary objective of which is to investigate the effect of oral fructanase administration on GI symptoms in healthy adults after consuming oatmeal with added inulin (25 grams). Secondary outcomes include breath hydrogen and methane levels, which serve as biomarkers of intestinal microbial fermentation. The investigators hypothesize that fructanase administration will lower the severity of GI symptoms after inulin consumption, as well as lower breath biomarkers of intestinal microbial fermentation, compared to placebo.

Conditions

• Digestive Health
• Gastrointestinal Health
• FODMAP Intolerance
• Food Sensitivity

Interventions

DIETARY_SUPPLEMENT

Fructanase

Participants will consume one capsule containing 400 INU inulinase (325 mg, includes maltodextrin) with a mixture of oatmeal (40 grams) and inulin (25 grams). Participants will be directed to consume the capsule after two spoonfuls of oatmeal. The fructanase was obtained from Aspergillus tubingensis.

DIETARY_SUPPLEMENT

Maltodextrin placebo

Participants will consume one capsule containing 300 mg maltodextrin with a mixture of oatmeal (40 grams) and inulin (25 grams). Participants will be directed to consume the capsule after two spoonfuls of oatmeal. The maltodextrin was obtained from tapioca.

Sponsors & Collaborators

• Biofortis, Inc.

  collaborator UNKNOWN

• BIO-CAT, Inc.

  lead INDUSTRY

Principal Investigators

• Aditi M. Shaw, MD · Biofortis, Inc.

Study Design

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

TRIPLE

Model

CROSSOVER

Eligibility

Min Age

20 Years

Max Age

50 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2024-11-04

Primary Completion

2024-12-16

Completion

2024-12-17

Countries

• United States

Study Locations