Ketogenic Diet as Protective Factor During COVID-19

Study Overview
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Brief Summary
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The novel coronavirus disease (COVID-19) is posing a serious challenge to the health-care systems worldwide, with an enormous impact on health conditions and loss of lives. More than 30 millions of recoveries worldwide were registered at the end of October 2020 with more than 1 million of deaths. As the disease continues to spread, strategies aimed to reduce hospitalization time in sub intensive unit care, thus reducing pressure on health system, but also to reduce some of the pathological features of COVID-19 such as inflammation and the cytokines storm. The ketogenic diet is a high fat, low carbohydrate, adequate-protein diet that promotes a physiological ketosis (due to an increase of liver ketone bodies production). High fat, low carbohydrate diets have been shown to reduce duration of ventilator support and partial pressure carbon dioxide in patients with acute respiratory failure. Moreover, the physiological increase in plasma levels of ketone bodies exerts important anti-inflammatory and immunomodulating effects, which may reveal as precious tools to reduce potential adverse outcomes of COVID-19 disease. The hypothesis of this study is that the administration of a ketogenic diet will improve gas exchange, reduce inflammation, and the duration of hospitalization. The plan is to enrol 28 patients with diagnosis of COVID-19 hospitalized but not in ICU with SPO2 higher than 88%.

Official Title
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Pilot Study: Ketogenic Diet as Protective Factor During SARS-CoV-2 Infection

Conditions
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Covid19

Intervention / Treatment
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* Dietary Supplement: Ketogenic diet with phytoextracts


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients hospitalized Hospital with COVID-19 diagnosis (nasopharyngeal and oropharyngeal swab) peripheral oxygen saturation higher tha 88% Exclusion Criteria: intensive unit care under forced ventilation peripheral oxygen saturation lower than 88% parenteral nutrition

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention<br>Patients will receive 21 days of a very low carbohydrate mediterranean ketogenic diet with phytoextracts and 7 days of a low carbohydrate diet | Dietary Supplement: Ketogenic diet with phytoextracts<br>* Patients were provided with an individualized nutritional ketogenic plan during hospitalization<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| inflammation panel: interleukine 6 (IL-6) | change in IL-6 levels. IL-6 is an inflammatory cytokine. Units: in pg/mL | Daily until patient's hospital discharge, up to 30 days | 
| inflammation panel: tumor necrosis factor alfa (TNFα) | change in TNFα levels. TNFα is an inflammatory cytokine Units: pg/mL | Daily untilpatient's hospital discharge, up to 30 days | 
| inflammation panel: C-reactive Protein (CRP) | change in CRP levels. CRP is an non specific index of inflammation Units: in mg/dL | Daily until patient's hospital discharge, up to 30 days | 
| inflammation panel: Erythrocyte sedimentation rate (ESR) | change in ESR. ESR is an non specific index of inflammationUnits: mm/h | Daily untilpatient's hospital discharge, up to 30 days | 
| coagulation panel: D-Dimer | change in D-Dimer levels. D-Dimer is a fibrin degradation product. Units: 0.5 mcg/ml Fibrinogen Equivalent Units (FEU) | Daily until patient's hospital discharge, up to 30 days | 
| coagulation panel: fibrinogen | change in fibrinogen levels. Fibrinogen is a protein involved in forming blood clots in the body. Units: mg/dL | Daily until patient's hospital discharge, up to 30 days | 
| coagulation panel: thrombin clotting time (TT) | change in TT. TT measures the time it takes for a clot to form in the plasma of a blood sample containing anticoagulant, after an excess of thrombin has been added. Units: seconds | Daily until patient's hospital discharge, up to 30 days | 
| coagulation panel: activated partial thromboplastin time (aPTT) | change inl aPTT. aPTT measures the overall speed at which blood clots by means of two consecutive series of biochemical reactions. Units: in seconds | Daily until patient's hospital discharge, up to 30 days | 
| Dyspnoea Visual Analog Scale Score (VAS) | Change in VAS. VAS is a horizontal line, 100 mm in length, and anchored by word descriptors at each end. The VAS dyspnea score uses no shortness of breath at all and maximum shortness of breath. The patient marks on the line the point that they feel represents the perception of their current state | Daily until patient's hospital discharge, up to 30 days | 
| Oxygen saturation | change in basal peripheral oxygen saturation percentage (%) | Continuosly, daily until patient's hospital discharge, up to 30 days | 
| Evaluation of Lungs conditions | Anteroposterior chest radiography (CXR) | Change from baseline, Every three days until patient's hospital discharge, up to 30 days | 
| The total hospital stay | Time from hospital admission to discharge from the hospital. | up to 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean Corpuscular Hemoglobin (MCH) | Change in the amount of hemoglobin per red blood cell. Mean cell hemoglobin is the average mass of hemoglobin per red blood cell in a sample of blood. Units: picograms (pg) per cell | Daily until patient's hospital discharge, up to 30 days | 
| Mean corpuscular volume (MCV) | change in the size of the red blood cells. Mean cell volume is a measure of the average volume of a red blood corpuscle. Units: femtoliters | Daily until patient's hospital discharge, up to 30 days | 
| mean corpuscular hemoglobin concentration (MCHC) | change in the amount of hemoglobin per unit volume. Mean cell hemoglobin concentration is the average concentration of hemoglobin in a given volume of blood. Unites: g/dl of red blood cells | Daily until patient's hospital discharge, up to 30 days | 
| haemoglobin Hb | change in total hemoglobin. Hemoglobin is an indirect way to measure red blood cells. Units: g/ dL | Daily until patient's hospital discharge, up to 30 days | 
| Red blood cells count | Change in the number of red blood cells. Red blood cell count measure anemia. Units: million cells per microliter (cells/mcL) | Daily until patient's hospital discharge, up to 30 days | 
| beta - hydroxybutyrate (BHB) | Change in ketonemia measured as concentration of blood BHB Units: mmol/L | Daily until patient's hospital discharge, up to 30 days | 
| Alanine transaminase (ALT) | Change in ALT. ALT is a liver function test. Units: mU/ml | Daily until patient's hospital discharge, up to 30 days | 
| Aspartate transaminase (AST) | Change in AST. AST ALT is a liver function test. Units : mU/ml | Daily until patient's hospital discharge, up to 30 days | 
| lactate dehydrogenase (LDH) | Change in LDH. LDH is a marker of tissues damage. Units: Unites/L | Daily until patient's hospital discharge, up to 30 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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inflammation, cytokines, SARS-CoV-2, Ketogenic diet, ketosis