Ketogenic Diet as Protective Factor During COVID-19

NCT04615975 | Unknown DMC

• 1 other identifier: KDSARS0120
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

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%.

Conditions

Covid19

Keywords

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

Outcome Measures

Primary Outcomes (12)

• inflammation panel: interleukine 6 (IL-6)

  change in IL-6 levels. IL-6 is an inflammatory cytokine. Units: in pg/mL

  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

  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

  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

  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)

  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

  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

  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

  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

  Daily until patient's hospital discharge, up to 30 days

• Oxygen saturation

  change in basal peripheral oxygen saturation percentage (%)

  Continuosly, daily until patient's hospital discharge, up to 30 days

• Evaluation of Lungs conditions

  Anteroposterior chest radiography (CXR)

  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.

  up to 30 days

Secondary Outcomes (9)

• Mean Corpuscular Hemoglobin (MCH)

  Daily until patient's hospital discharge, up to 30 days

• Mean corpuscular volume (MCV)

  Daily until patient's hospital discharge, up to 30 days

• mean corpuscular hemoglobin concentration (MCHC)

  Daily until patient's hospital discharge, up to 30 days

• haemoglobin Hb

  Daily until patient's hospital discharge, up to 30 days

• Red blood cells count

  Daily until patient's hospital discharge, up to 30 days

Study Arms (1)

Intervention

EXPERIMENTAL

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

Interventions

Ketogenic diet with phytoextracts DIETARY_SUPPLEMENT

Patients were provided with an individualized nutritional ketogenic plan during hospitalization

Intervention

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients hospitalized Hospital with COVID-19 diagnosis (nasopharyngeal and oropharyngeal swab)
• peripheral oxygen saturation higher tha 88%

You may not qualify if:

• intensive unit care
• under forced ventilation
• peripheral oxygen saturation lower than 88%
• parenteral nutrition

Sponsors & Collaborators

• University of Padova: lead
• San Bortolo Hospital - Vicenza: collaborator

Study Sites (1)

Ospedale San Bortolo

Vicenza, 36100, Italy

RECRUITING

MeSH Terms

Conditions

COVID-19; Inflammation; Ketosis

Interventions

Diet, Ketogenic

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Acidosis; Acid-Base Imbalance; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Diet, Carbohydrate-Restricted; Diet Therapy; Nutrition Therapy; Therapeutics; Diet; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Study Officials

• Antonio Paoli, MD

  University of Padova

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Antonio Paoli, MD

CONTACT

+393338911322; antonio.paoli@unipd.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Full Professor

Study Record Dates

• First Submitted: October 31, 2020
• First Posted: November 4, 2020
• Study Start: November 1, 2020
• Primary Completion: July 30, 2021
• Study Completion: August 30, 2021
• Last Updated: November 4, 2020

Record last verified: 2020-11

Locations

IT (1)