Eucaloric Ketogenic Diet in COVID-19 Cytokine Storm Syndrome (ketocovidiet)

Randomized Open Controlled Clinical Trial to Evaluate the Effectiveness of a Eucaloric Ketogenic Nutrition in Comparison With a Standard Nutrition in Covid-19 Disease in Reducing Cytokine Storm Syndrome and ARDS

Covid 19 pandemia is causing millions of deaths worldwide. To date, the evidence gathered suggests that the subgroup of patients who present the most serious clinical feature of COVID-19 could have a "cytokine storm syndrome" better defined as secondary hemophagocytic lymphohistiocytosis (sHLH), characterized by acute respiratory distress (ARDS) and septic shock, followed by multi-organ failure due to an excess of cytokines induced by the inflammatory response to the virus. The reduction of phagocytic hyperactivation represents a possible treatment for HLH. Lowering the availability of glucose, the only substrate of aerobic glycolysis and of the Warburg effect in activated macrophages, through the use of ketogenic diets could be a promising solution. Actually diet is not recognized as impacting on the evolution of COVID-19, however, scientific literature data show that a low carbohydrate and high lipid diet (ketogenic diet) can inhibit inflammation and lead to a clinical improvement of respiratory function. The hypothesis of this study is that the administration of a ketogenic diet could improve mortality, lower the access to ICU and the need of NIV. The plan is to enroll 50 patients with COVID 19 infection and administer a 1:4 ketogenic formula during hospitalization in order to verify these outcomes.

This is a controlled, randomized, open-label, clinical trial designed to determine whether a ketogenic diet,in comparison with a standard diet, improves mortality and reduces ventilator requirements or ICU access in patients with coronavirus disease. The study team will prospectively enroll 50 patients with COVID-19 infection administering a 4:1 ratio ketogenic formula (both enteral or parenteral) and 50 with standard diet

Eucaloric Ketogenic diet % composition : protein (27%), lipids (67%), carbohydrates (6%: <30g/day). In pts in artificial nutrition : Eucaloric Ketogenic parenteral nutrition % composition : aminoacids (27%), lipids (67%), carbohydrates (6%: <30g/day)

Combined endpoint "mortality, ICU transfer or need for CPAP or intubation" in the ketogenic group diet vs standard one

Inclusion Criteria: documented clinical diagnosis of COVID-19 supported by clinical features and by the positivity to at least one pharyngeal swab age ≥18 years informed written consent Exclusion Criteria: Type I diabetes Type II diabetes in therapy with insulin, sulphonylureas, repaglinide, GLP-1 analogues, SGLT2 inhibitors Recent acute cardiovascular event (within a month) Food allergies to diet components Any metabolic disorder capable of influencing gluconeogenesis Clinical history of severe hypertriglyceridemia with or without pancreatitis Pregnancy and/or breastfeeding

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