Eucaloric Ketogenic Diet in COVID-19 Cytokine Storm Syndrome

Not Applicable

• Conditions: Ketogenic Dieting; Covid19
• Interventions: Other: Ketogenic diet

• Registration Number: NCT04492228
• Lead Sponsor: Ospedale Policlinico San Martino

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-07-25
• Study First Submitted QC: 2020-07-29
• Study First Posted: 2020-07-30
• Status Verified: 2020-09
• Study Start: 2020-09-01
• Last Update Submitted: 2020-09-28
• Last Update Posted: 2020-09-30
• Primary Completion: 2020-12-31
• Study Completion: 2021-05-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Ketogenic diet group	Ketogenic diet	patients with COVID-19 feeding with a ketogenic diet (4.1 formula)

Primary Outcome Measures

Name	Time	Method
Access in Intensive Care Unit in the ketogenic group diet vs standard one	Up to nine months
Mortality rate 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
Need of Non Invasive Ventilation in the ketogenic group diet vs standard one	Up to nine months

Trial Locations

Locations (1)

Samir Giuseppe Sukkar; 🇮🇹 Genova, Italy