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Ketogenic Diet as Protective Factor During COVID-19

Primary Purpose

Covid19

Status
Unknown status
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Ketogenic diet with phytoextracts
Sponsored by
University of Padova
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Covid19 focused on measuring inflammation, cytokines, SARS-CoV-2, Ketogenic diet, ketosis

Eligibility Criteria

18 Years - 100 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Ospedale San BortoloRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Intervention

Arm Description

Patients will receive 21 days of a very low carbohydrate mediterranean ketogenic diet with phytoextracts and 7 days of a low carbohydrate diet

Outcomes

Primary Outcome Measures

inflammation panel: interleukine 6 (IL-6)
change in IL-6 levels. IL-6 is an inflammatory cytokine. Units: in pg/mL
inflammation panel: tumor necrosis factor alfa (TNFα)
change in TNFα levels. TNFα is an inflammatory cytokine Units: pg/mL
inflammation panel: C-reactive Protein (CRP)
change in CRP levels. CRP is an non specific index of inflammation Units: in mg/dL
inflammation panel: Erythrocyte sedimentation rate (ESR)
change in ESR. ESR is an non specific index of inflammationUnits: mm/h
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)
coagulation panel: fibrinogen
change in fibrinogen levels. Fibrinogen is a protein involved in forming blood clots in the body. Units: mg/dL
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
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
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
Oxygen saturation
change in basal peripheral oxygen saturation percentage (%)
Evaluation of Lungs conditions
Anteroposterior chest radiography (CXR)
The total hospital stay
Time from hospital admission to discharge from the hospital.

Secondary Outcome Measures

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
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
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
haemoglobin Hb
change in total hemoglobin. Hemoglobin is an indirect way to measure red blood cells. Units: g/ dL
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)
beta - hydroxybutyrate (BHB)
Change in ketonemia measured as concentration of blood BHB Units: mmol/L
Alanine transaminase (ALT)
Change in ALT. ALT is a liver function test. Units: mU/ml
Aspartate transaminase (AST)
Change in AST. AST ALT is a liver function test. Units : mU/ml
lactate dehydrogenase (LDH)
Change in LDH. LDH is a marker of tissues damage. Units: Unites/L

Full Information

First Posted
October 31, 2020
Last Updated
November 3, 2020
Sponsor
University of Padova
Collaborators
San Bortolo Hospital - Vicenza
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1. Study Identification

Unique Protocol Identification Number
NCT04615975
Brief Title
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

2. Study Status

Record Verification Date
November 2020
Overall Recruitment Status
Unknown status
Study Start Date
November 1, 2020 (Actual)
Primary Completion Date
July 30, 2021 (Anticipated)
Study Completion Date
August 30, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Padova
Collaborators
San Bortolo Hospital - Vicenza

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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%.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Covid19
Keywords
inflammation, cytokines, SARS-CoV-2, Ketogenic diet, ketosis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
28 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intervention
Arm Type
Experimental
Arm Description
Patients will receive 21 days of a very low carbohydrate mediterranean ketogenic diet with phytoextracts and 7 days of a low carbohydrate diet
Intervention Type
Dietary Supplement
Intervention Name(s)
Ketogenic diet with phytoextracts
Intervention Description
Patients were provided with an individualized nutritional ketogenic plan during hospitalization
Primary Outcome Measure Information:
Title
inflammation panel: interleukine 6 (IL-6)
Description
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
Title
inflammation panel: tumor necrosis factor alfa (TNFα)
Description
change in TNFα levels. TNFα is an inflammatory cytokine Units: pg/mL
Time Frame
Daily untilpatient's hospital discharge, up to 30 days
Title
inflammation panel: C-reactive Protein (CRP)
Description
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
Title
inflammation panel: Erythrocyte sedimentation rate (ESR)
Description
change in ESR. ESR is an non specific index of inflammationUnits: mm/h
Time Frame
Daily untilpatient's hospital discharge, up to 30 days
Title
coagulation panel: D-Dimer
Description
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
Title
coagulation panel: fibrinogen
Description
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
Title
coagulation panel: thrombin clotting time (TT)
Description
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
Title
coagulation panel: activated partial thromboplastin time (aPTT)
Description
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
Title
Dyspnoea Visual Analog Scale Score (VAS)
Description
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
Title
Oxygen saturation
Description
change in basal peripheral oxygen saturation percentage (%)
Time Frame
Continuosly, daily until patient's hospital discharge, up to 30 days
Title
Evaluation of Lungs conditions
Description
Anteroposterior chest radiography (CXR)
Time Frame
Change from baseline, Every three days until patient's hospital discharge, up to 30 days
Title
The total hospital stay
Description
Time from hospital admission to discharge from the hospital.
Time Frame
up to 30 days
Secondary Outcome Measure Information:
Title
Mean Corpuscular Hemoglobin (MCH)
Description
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
Title
Mean corpuscular volume (MCV)
Description
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
Title
mean corpuscular hemoglobin concentration (MCHC)
Description
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
Title
haemoglobin Hb
Description
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
Title
Red blood cells count
Description
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
Title
beta - hydroxybutyrate (BHB)
Description
Change in ketonemia measured as concentration of blood BHB Units: mmol/L
Time Frame
Daily until patient's hospital discharge, up to 30 days
Title
Alanine transaminase (ALT)
Description
Change in ALT. ALT is a liver function test. Units: mU/ml
Time Frame
Daily until patient's hospital discharge, up to 30 days
Title
Aspartate transaminase (AST)
Description
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
Title
lactate dehydrogenase (LDH)
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Antonio Paoli, MD
Phone
+393338911322
Email
antonio.paoli@unipd.it
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Antonio Paoli, MD
Organizational Affiliation
University of Padova
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ospedale San Bortolo
City
Vicenza
ZIP/Postal Code
36100
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lorenzo Cenci, MD
Phone
+393485405665

12. IPD Sharing Statement

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Ketogenic Diet as Protective Factor During COVID-19

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