Safety and tolerability of Monoacylglycerol-rich oil as a novel predigested dietary fat source of an enteral formula in healthy adults and adolescents: Two single-arm, open-label studies.

Background & Aims: Enteral formulas containing predigested lipids to support the needs of patients with fat maldigestion are currently unavailable. Monoacylglycerol (MAG)-rich oils offer potential benefits for fat absorption without prior digestion, but their safety and tolerability in enteral formulas need evaluation. We assessed the safety and tolerability of a new formula containing predigested lipids in the form of MAG-rich oil.

Methods: Two cohorts of healthy volunteers, consisting of 12 adults (aged ≥18 years) followed by 12 adolescents (aged 12-17 years) were recruited. Participants consumed an oral nutritional supplement containing MAG-rich oil as the main lipid source (up to 37 g/day) three times daily for 13 days. Safety, tolerability, gastrointestinal (GI) symptoms, anthropometric, and blood parameters were assessed.

Results: All 24 participants completed the study without discontinuing the formula with good compliance. Median Visual Analog Scale scores for GI symptoms were low (on average 0.2 out of 10) in both groups, and the Gastrointestinal Symptom Rating Scale scores remained mostly unchanged (1-2 out of 7), indicating no or minimal discomfort. Stool frequency and consistency remained within normal limits throughout the study. Serum triglyceride and cholesterol levels showed no clinically significant changes, and the fatty acid profile and fat-soluble vitamins showed a favorable trend at the end of the study. Adverse events (AEs) were minor, and none were serious.

Conclusions: The new formula containing MAG-rich oil was safe and well tolerated in healthy adults and adolescents. This formula could potentially address a gap in the nutritional management of patients with EPI and fat maldigestion. Further studies are required to assess the efficacy of this new formula in the target population.

Trial Registration: https://clinicaltrials.gov/: NCT05100901 and NCT05923593.