Eucaloric Ketogenic Diet in COVID-19 Cytokine Storm Syndrome

Covid19 Clinical Trial

— ketocovidiet  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04492228
• Other study ID #: KETOCOV-1
• Status: Recruiting
• Phase: N/A
• Start date: September 1, 2020
• Est. completion date: May 30, 2021

Study information

• Verified date: September 2020
• Source: Ospedale Policlinico San Martino
• Contact: Samir G Sukkar, MD
• Phone: 0105553985
• Email: samir.sukkar[@]hsanmartino.it
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: May 30, 2021
• Est. primary completion date: December 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Covid19
• Ketogenic Dieting

Intervention

Other:
• Ketogenic 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)

Locations

Country	Name	City	State
Italy	Samir Giuseppe Sukkar	Genova

Sponsors (1)

Lead Sponsor	Collaborator
Ospedale Policlinico San Martino

Country where clinical trial is conducted

Italy, 

References & Publications (20)

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* Note: There are 20 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mortality rate in the ketogenic group diet vs standard one		Up to nine months
Primary	Access in Intensive Care Unit in the ketogenic group diet vs standard one		Up to nine months
Primary	Need of Non Invasive Ventilation in the ketogenic group diet vs standard one		Up to nine months
Primary	Combined endpoint "mortality, ICU transfer or need for CPAP or intubation" in the ketogenic group diet vs standard one		Up to nine months