Ketogenic Diet as Protective Factor During COVID-19

• ClinicalTrials.gov Identifier: NCT04615975
• Recruitment Status: Unknown
• First Posted: November 4, 2020
• Last Update Posted: November 4, 2020
• Sponsor: University of Padova
• Collaborator: San Bortolo Hospital - Vicenza
• Information provided by (Responsible Party): Antonio Paoli, University of Padova

Study Description

Brief Summary:

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%.

Condition or disease	Intervention/treatment	Phase
Covid19	Dietary Supplement: Ketogenic diet with phytoextracts	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 28 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Pilot Study: Ketogenic Diet as Protective Factor During SARS-CoV-2 Infection
• Actual Study Start Date: November 1, 2020
• Estimated Primary Completion Date: July 30, 2021
• Estimated Study Completion Date: August 30, 2021

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures :

1. inflammation panel: interleukine 6 (IL-6) [ Time Frame: Daily until patient's hospital discharge, up to 30 days ]
   change in IL-6 levels. IL-6 is an inflammatory cytokine. Units: in pg/mL
2. inflammation panel: tumor necrosis factor alfa (TNFα) [ Time Frame: Daily untilpatient's hospital discharge, up to 30 days ]
   change in TNFα levels. TNFα is an inflammatory cytokine Units: pg/mL
3. inflammation panel: C-reactive Protein (CRP) [ Time Frame: Daily until patient's hospital discharge, up to 30 days ]
   change in CRP levels. CRP is an non specific index of inflammation Units: in mg/dL
4. inflammation panel: Erythrocyte sedimentation rate (ESR) [ Time Frame: Daily untilpatient's hospital discharge, up to 30 days ]
   change in ESR. ESR is an non specific index of inflammationUnits: mm/h
5. coagulation panel: D-Dimer [ Time Frame: Daily until patient's hospital discharge, up to 30 days ]
   change in D-Dimer levels. D-Dimer is a fibrin degradation product. Units: 0.5 mcg/ml Fibrinogen Equivalent Units (FEU)
6. coagulation panel: fibrinogen [ Time Frame: Daily until patient's hospital discharge, up to 30 days ]
   change in fibrinogen levels. Fibrinogen is a protein involved in forming blood clots in the body. Units: mg/dL
7. coagulation panel: thrombin clotting time (TT) [ Time Frame: Daily until patient's hospital discharge, up to 30 days ]
   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
8. coagulation panel: activated partial thromboplastin time (aPTT) [ Time Frame: Daily until patient's hospital discharge, up to 30 days ]
   change inl aPTT. aPTT measures the overall speed at which blood clots by means of two consecutive series of biochemical reactions. Units: in seconds
9. Dyspnoea Visual Analog Scale Score (VAS) [ Time Frame: Daily until patient's hospital discharge, up to 30 days ]
   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
10. Oxygen saturation [ Time Frame: Continuosly, daily until patient's hospital discharge, up to 30 days ]
    change in basal peripheral oxygen saturation percentage (%)
11. Evaluation of Lungs conditions [ Time Frame: Change from baseline, Every three days until patient's hospital discharge, up to 30 days ]
    Anteroposterior chest radiography (CXR)
12. The total hospital stay [ Time Frame: up to 30 days ]
    Time from hospital admission to discharge from the hospital.

Secondary Outcome Measures :

1. Mean Corpuscular Hemoglobin (MCH) [ Time Frame: Daily until patient's hospital discharge, up to 30 days ]
   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
2. Mean corpuscular volume (MCV) [ Time Frame: Daily until patient's hospital discharge, up to 30 days ]
   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
3. mean corpuscular hemoglobin concentration (MCHC) [ Time Frame: Daily until patient's hospital discharge, up to 30 days ]
   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
4. haemoglobin Hb [ Time Frame: Daily until patient's hospital discharge, up to 30 days ]
   change in total hemoglobin. Hemoglobin is an indirect way to measure red blood cells. Units: g/ dL
5. Red blood cells count [ Time Frame: Daily until patient's hospital discharge, up to 30 days ]
   Change in the number of red blood cells. Red blood cell count measure anemia. Units: million cells per microliter (cells/mcL)
6. beta - hydroxybutyrate (BHB) [ Time Frame: Daily until patient's hospital discharge, up to 30 days ]
   Change in ketonemia measured as concentration of blood BHB Units: mmol/L
7. Alanine transaminase (ALT) [ Time Frame: Daily until patient's hospital discharge, up to 30 days ]
   Change in ALT. ALT is a liver function test. Units: mU/ml
8. Aspartate transaminase (AST) [ Time Frame: Daily until patient's hospital discharge, up to 30 days ]
   Change in AST. AST ALT is a liver function test. Units : mU/ml
9. lactate dehydrogenase (LDH) [ Time Frame: Daily until patient's hospital discharge, up to 30 days ]
   Change in LDH. LDH is a marker of tissues damage. Units: Unites/L

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 100 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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

Contacts and Locations

Contacts

Contact: Antonio Paoli, MD; +393338911322; antonio.paoli@unipd.it

Locations

Italy

Ospedale San Bortolo; Recruiting

Vicenza, Italy, 36100

Contact: Lorenzo Cenci, MD +393485405665

Sponsors and Collaborators

University of Padova

San Bortolo Hospital - Vicenza

Investigators

• Principal Investigator: Antonio Paoli, MD; University of Padova

More Information

• Responsible Party: Antonio Paoli, Full Professor, University of Padova
• ClinicalTrials.gov Identifier: NCT04615975
• Other Study ID Numbers: KDSARS0120
• First Posted: November 4, 2020
• Last Update Posted: November 4, 2020
• Last Verified: November 2020

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Antonio Paoli, University of Padova:

inflammation; cytokines; SARS-CoV-2; Ketogenic diet; ketosis

Additional relevant MeSH terms:

COVID-19; Respiratory Tract Infections; Infections; Pneumonia, Viral; Pneumonia; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases