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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
100
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)
Samir Giuseppe Sukkar
Genova, Italy
RECRUITINGMortality rate in the ketogenic group diet vs standard one
Time frame: Up to nine months
Access in Intensive Care Unit in the ketogenic group diet vs standard one
Time frame: Up to nine months
Need of Non Invasive Ventilation in the ketogenic group diet vs standard one
Time frame: Up to nine months
Combined endpoint "mortality, ICU transfer or need for CPAP or intubation" in the ketogenic group diet vs standard one
Time frame: Up to nine months
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