Covid19, Ketogenic Dieting
Conditions
Brief summary
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.
Interventions
OTHERKetogenic 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)
Sponsors
Ospedale Policlinico San Martino
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
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
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Mortality rate in the ketogenic group diet vs standard one | Up to nine months |
| Access in Intensive Care Unit in the ketogenic group diet vs standard one | Up to nine months |
| Need of Non Invasive Ventilation in the ketogenic group diet vs standard one | Up to nine months |
| Combined endpoint mortality, ICU transfer or need for CPAP or intubation in the ketogenic group diet vs standard one | Up to nine months |
Countries
Italy
Contacts
Primary ContactSamir G Sukkar, MD
Outcome results
None listed