An interventional study of Ketogenic diet in Covid19 and Ketogenic Dieting, sponsored by Ospedale Policlinico San Martino. Status unknown at 1 site in Italy. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-09-30.
Sponsored by Ospedale Policlinico San Martino · Not applicable, Interventional, and Treatment
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.
7,640 studies on the registry are indexed under COVID-19; 488 are open to participants now.
This study's planned enrollment of 100 is close to the median of 100 across 4,099 interventional studies indexed under COVID-19.
Browse COVID-19 studies →Ospedale Policlinico San Martino is the lead sponsor of 30 studies on the registry; 11 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
patients with COVID-19 feeding with a ketogenic diet (4.1 formula)
Other: Ketogenic diet
patients with COVID-19 feeding with a 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)
Mortality 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
Plan to share: No
This study is status unknown, as verified in Sep 2020. You cannot join it, but the record below documents what was studied.
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Ospedale Policlinico San Martino