Eucaloric Ketogenic Diet in COVID-19 Cytokine Storm Syndrome

NCT04492228 | Unknown

• 1 other identifier: KETOCOV-1
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Covid19; Ketogenic Dieting

Outcome Measures

Primary Outcomes (4)

• 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

Study Arms (2)

Ketogenic diet group

EXPERIMENTAL

patients with COVID-19 feeding with a ketogenic diet (4.1 formula)

Other: Ketogenic diet

Standard diet group

NO INTERVENTION

patients with COVID-19 feeding with a standard diet

Interventions

Ketogenic diet OTHER

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)

Ketogenic diet group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ospedale Policlinico San Martino: lead

Study Sites (1)

Samir Giuseppe Sukkar

Genova, 16132, Italy

RECRUITING

Related Publications (20)

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MeSH Terms

Conditions

COVID-19

Interventions

Diet, Ketogenic

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Diet, Carbohydrate-Restricted; Diet Therapy; Nutrition Therapy; Therapeutics; Diet; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Central Study Contacts

Samir G Sukkar, MD

CONTACT

0105553985; samir.sukkar@hsanmartino.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr Samir Giuseppe Sukkar

Model Details: 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

Study Record Dates

• First Submitted: July 25, 2020
• First Posted: July 30, 2020
• Study Start: September 1, 2020
• Primary Completion: December 31, 2020
• Study Completion: May 30, 2021
• Last Updated: September 30, 2020

Record last verified: 2020-09

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)