Efficacy of a New Immunonutrition Formula with Extra Virgin Olive Oil in the Reduction of Complications in Surgeries of Upper Digestive Tract Tumours Provisionally Accepted

Rocío Villar Taibo¹ Alfonso Vidal Casariego^2* Alicia Santamaría Nieto¹ Ana Cantón Blanco¹ Ana B. Crujeiras^{3, 4} Gloria Lugo Rodríguez⁵ Gemma Rodríguez Carnero¹ Francisco Pita Gutiérrez⁵ Antia Fernandez-Pombo¹ Everardo Díaz López¹ Andrea Roman Eyo¹ Uxía Rodríguez Lavandeira⁵ Alberto Pena Dubra¹ Miguel Á. Martínez Olmos^{1, 4}

• ¹Department of Endocrinology and Nutrition, University Hospital Complex of Santiago, Spain
• ²Endocrinology and Nutrition Department, Complejo Hospitalario Universitario de A Coruña,, Spain
• ³Unidad de Epigenómica, Instituto de Investigacion Sanitaria de Santiago de Compostela (IDIS), Spain
• ⁴CIBER Fisiopatología Obesidad y Nutrición (CIBEROBN), Spain
• ⁵Department of Endocrinology and Nutrition, Biomedical Research Institute Complejo Hospitalario Universitario de A Coruña, Spain

Background: to demonstrate whether a nutritional supplement enriched with arginine, nucleotides, omega-3 fatty acids, and extra virgin olive oil reduces postoperative complications in patients with tumours in the upper digestive tract. Methods: a randomised, controlled, double-blind, multicentre clinical trial, in which a new immunomodulatory formula with extra virgin olive oil was compared with a standard isoprotein and isoenergetic formula. Patients with gastric, esophageal or biliopancreatic tumours were recruited to receive two units of immunomodulatory formula or control, five days before the surgical intervention. Results: 119 patients were recruited. There was a significant reduction in the number of reinterventions (7.7 vs. 20.4%; p = 0.044) in the intervention group. There was a significant reduction in the development of fistulas in patients with phase angles >5.7º. Also, there were fewer readmissions after biliopancreatic surgeries (0.0 vs. 100%; p = 0.014). The length of hospital stay was similar between groups; however, with the immunomodulatory formula, the patients exhibited greater phase angles at the end of follow-up. Conclusions: the immunomodulatory formula with extra virgin Con formato: Español (España) 2 olive oil administered five days before surgery for stomach, esophageal and biliopancreatic tumours improved cellular health and reduced postoperative complications.