Impact of an oral nutritional supplement enriched in leucine, EPA, DHA, and β-glucans on the increase of muscle mass in patients with cancer and malnutrition: The alisenoc trial

Methods: A randomized, double-blind, parallel-group, controlled, multicenter clinical trial was conducted in patients with cancer and malnutrition during outpatient treatment. Patients were randomized to receive either a specific high-calorie, high-protein ONS enriched with leucine, EPA, DHA, and β-glucans or an isocaloric, isonitrogenous standard ONS for eight weeks. Malnutrition was diagnosed using the SGA and body composition was evaluated using bioimpedance. Results: 57 patients were recruited and 37 completed the intervention period. After the nutritional intervention, patients who received the enhanced-ONS showed a significant increase in muscle mass, which was not detected with the standard ONS [1.92 (4.31) kg vs −0.68 (1.45) kg); p = 0.009)], and there was no significant reduction in the percentage of patients with severe and moderate malnutrition. Conclusion: An enhanced ONS enriched in EPA, DHA, leucine, and β-glucans increases muscle mass and could promote nutritional and functional status recovery in patients with cancer and malnourishment.Trial registration: NCT04184713.