Clinical trial NCT04615975: Ketogenic Diet as Protective Factor During COVID-19
Official title: Pilot Study: Ketogenic Diet as Protective Factor During SARS-CoV-2 Infection
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Covid19
Keywords: inflammation
cytokines
SARS-CoV-2
Ketogenic diet
ketosis
Lead sponsor: University of Padova
Sponsor class: OTHER
Collaborators: name: San Bortolo Hospital - Vicenza
First posted: 2020-11-04
Enrollment: 28
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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%.


Eligibility 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

Primary outcomes:
measure: inflammation panel: interleukine 6 (IL-6)
timeFrame: Daily until patient's hospital discharge, up to 30 days
measure: inflammation panel: tumor necrosis factor alfa (TNFα)
timeFrame: Daily untilpatient's hospital discharge, up to 30 days
measure: inflammation panel: C-reactive Protein (CRP)
timeFrame: Daily until patient's hospital discharge, up to 30 days
measure: inflammation panel: Erythrocyte sedimentation rate (ESR)
timeFrame: Daily untilpatient's hospital discharge, up to 30 days
measure: coagulation panel: D-Dimer
timeFrame: Daily until patient's hospital discharge, up to 30 days
measure: coagulation panel: fibrinogen
timeFrame: Daily until patient's hospital discharge, up to 30 days
measure: coagulation panel: thrombin clotting time (TT)
timeFrame: Daily until patient's hospital discharge, up to 30 days
measure: coagulation panel: activated partial thromboplastin time (aPTT)
timeFrame: Daily until patient's hospital discharge, up to 30 days
measure: Dyspnoea Visual Analog Scale Score (VAS)
timeFrame: Daily until patient's hospital discharge, up to 30 days
measure: Oxygen saturation
timeFrame: Continuosly, daily until patient's hospital discharge, up to 30 days
measure: Evaluation of Lungs conditions
timeFrame: Change from baseline, Every three days until patient's hospital discharge, up to 30 days
measure: The total hospital stay
timeFrame: up to 30 days
Secondary outcomes:
measure: Mean Corpuscular Hemoglobin (MCH)
timeFrame: Daily until patient's hospital discharge, up to 30 days
measure: Mean corpuscular volume (MCV)
timeFrame: Daily until patient's hospital discharge, up to 30 days
measure: mean corpuscular hemoglobin concentration (MCHC)
timeFrame: Daily until patient's hospital discharge, up to 30 days
measure: haemoglobin Hb
timeFrame: Daily until patient's hospital discharge, up to 30 days
measure: Red blood cells count
timeFrame: Daily until patient's hospital discharge, up to 30 days
measure: beta - hydroxybutyrate (BHB)
timeFrame: Daily until patient's hospital discharge, up to 30 days
measure: Alanine transaminase (ALT)
timeFrame: Daily until patient's hospital discharge, up to 30 days
measure: Aspartate transaminase (AST)
timeFrame: Daily until patient's hospital discharge, up to 30 days
measure: lactate dehydrogenase (LDH)
timeFrame: Daily until patient's hospital discharge, up to 30 days
Other outcomes:
Locations:
city: Vicenza
country: Italy
facility: Ospedale San Bortolo
Study officials:
affiliation: University of Padova
name: Antonio Paoli, MD
role: PRINCIPAL_INVESTIGATOR
References: