Gastrointestinal tolerance of low FODMAP oral nutrition supplements in healthy human subjects: a randomized controlled trial

BACKGROUND There has been increasing interest in utilizing a diet low in fermentable oligosaccharides, disaccharides, monosaccharides and polyols (FODMAPs) for the treatment of irritable bowel syndrome (IBS), a functional gastrointestinal disease. While studies have indicated that this diet can be effective at symptom reduction, it is a restrictive diet and patients may find it challenging to find low FODMAP products to meet their nutrient needs. The primary objective of this study was to assess the gastrointestinal (GI) tolerance of three low FODMAP oral nutrition supplements (ONS) in healthy adults. METHODS A double-blind randomized controlled crossover study was conducted in 21 healthy adults (19-32 years). Fasted subjects consumed one of four treatments at each visit, with a one week wash out period between visits. Each participant received all treatments. Treatments included three low FODMAP ONS formulas (A, B, and C) as well as a positive control consisting of 5 g fructooligosaccharides (FOS) mixed in lactose-free milk. Breath hydrogen was measured at baseline, 1, 2, 3, and 4 h post treatment consumption. Subjective GI symptom questionnaires were completed at baseline, 0.5, 1, 1.5, 2, 3, 4, 12, 24 and 48 h following treatment consumption. Mean breath hydrogen concentrations and baseline corrected area under the curve for both breath hydrogen and GI symptoms were analyzed and compared between treatments. Significance was determined at P < 0.05. RESULTS The positive control resulted in higher breath hydrogen response compared to all three of the low FODMAP ONS beverages at 3 and 4 h after consumption. There were no differences in GI symptom response between treatments. CONCLUSIONS All treatments were well tolerated in healthy participants. The low FODMAP formulas resulted in a lower breath hydrogen response compared to the positive control, and may be better tolerated in individuals with IBS. More research should be conducted to better understand the GI tolerance of low FODMAP ONS in individuals with IBS. TRIAL REGISTRATION The protocol for this study was registered on ClinicalTrials.gov in January 2016 (Clinical Trials ID: NCT02667184 ).