Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 4 for:    Covid19 | ketogenic diet
Previous Study | Return to List | Next Study

Ketogenic Diet as Protective Factor During COVID-19

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04615975
Recruitment Status : Recruiting
First Posted : November 4, 2020
Last Update Posted : November 4, 2020
Sponsor:
Collaborator:
San Bortolo Hospital - Vicenza
Information provided by (Responsible Party):
Antonio Paoli, University of Padova

Tracking Information
First Submitted Date  ICMJE October 31, 2020
First Posted Date  ICMJE November 4, 2020
Last Update Posted Date November 4, 2020
Actual Study Start Date  ICMJE November 1, 2020
Estimated Primary Completion Date July 30, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 3, 2020)
  • 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
  • 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
  • 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
  • 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
  • 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)
  • 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
  • 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
  • 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
  • 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
  • Oxygen saturation [ Time Frame: Continuosly, daily until patient's hospital discharge, up to 30 days ]
    change in basal peripheral oxygen saturation percentage (%)
  • 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)
  • The total hospital stay [ Time Frame: up to 30 days ]
    Time from hospital admission to discharge from the hospital.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: November 3, 2020)
  • 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
  • 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
  • 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
  • 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
  • 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)
  • 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
  • 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
  • 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
  • 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Ketogenic Diet as Protective Factor During COVID-19
Official Title  ICMJE Pilot Study: Ketogenic Diet as Protective Factor During SARS-CoV-2 Infection
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%.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Covid19
Intervention  ICMJE Dietary Supplement: Ketogenic diet with phytoextracts
Patients were provided with an individualized nutritional ketogenic plan during hospitalization
Study Arms  ICMJE 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
Intervention: Dietary Supplement: Ketogenic diet with phytoextracts
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: November 3, 2020)
28
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE August 30, 2021
Estimated Primary Completion Date July 30, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 100 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Antonio Paoli, MD +393338911322 antonio.paoli@unipd.it
Listed Location Countries  ICMJE Italy
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04615975
Other Study ID Numbers  ICMJE KDSARS0120
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Antonio Paoli, University of Padova
Study Sponsor  ICMJE University of Padova
Collaborators  ICMJE San Bortolo Hospital - Vicenza
Investigators  ICMJE
Principal Investigator: Antonio Paoli, MD University of Padova
PRS Account University of Padova
Verification Date November 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP