Ketogenic Diet as Protective Factor During COVID-19

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

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%.

Study Overview

• Status: Unknown
• Conditions: Covid19
• Intervention / Treatment: Dietary supplement: Ketogenic diet with phytoextracts

• Study Type: Interventional
• Enrollment (Anticipated): 28
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • Vicenza, Italy, 36100
    • Recruiting
    • Ospedale san Bortolo
    • Contact: Lorenzo Cenci, MD; Phone Number: +393485405665

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 96 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention; 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; Patients were provided with an individualized nutritional ketogenic plan during hospitalization

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University of Padova
• Collaborators: San Bortolo Hospital - Vicenza

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2020
• Primary Completion (Anticipated): July 30, 2021
• Study Completion (Anticipated): August 30, 2021

Study Registration Dates

• First Submitted: October 31, 2020
• First Submitted That Met QC Criteria: November 3, 2020
• First Posted (Actual): November 4, 2020

Study Record Updates

• Last Update Posted (Actual): November 4, 2020
• Last Update Submitted That Met QC Criteria: November 3, 2020
• Last Verified: November 1, 2020

More Information

Terms related to this study

• Keywords: SARS-CoV-2; inflammation; cytokines; ketosis; Ketogenic diet
• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19
• Other Study ID Numbers: KDSARS0120

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No