An interventional study of Ketogenic diet with phytoextracts in Covid19, sponsored by University of Padova. Status unknown at 1 site in Italy. Open to participants aged 18 Years to 100 Years. Per ClinicalTrials.gov, last updated 2020-11-04.
Sponsored by University of Padova · Not applicable, Interventional, and Treatment
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%.
7,640 studies on the registry are indexed under COVID-19; 488 are open to participants now.
This study's planned enrollment of 28 is below the median of 100 across 4,099 interventional studies indexed under COVID-19.
Browse COVID-19 studies →University of Padova is the lead sponsor of 210 studies on the registry; 42 are open to participants now.
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Exclusion Criteria:
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
inflammation panel: interleukine 6 (IL-6)
change in IL-6 levels. IL-6 is an inflammatory cytokine. Units: in pg/mL
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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)
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Daily until patient's hospital discharge, up to 30 days
Oxygen saturation
change in basal peripheral oxygen saturation percentage (%)
Time frame: Continuosly, daily until patient's hospital discharge, up to 30 days
Evaluation of Lungs conditions
Anteroposterior chest radiography (CXR)
Time frame: 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.
Time frame: up to 30 days
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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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)
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Daily until patient's hospital discharge, up to 30 days
This study is status unknown, as verified in Nov 2020. You cannot join it, but the record below documents what was studied.
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University of Padova