Covid19NCT04615975
Ketogenic Diet as Protective Factor During COVID-19
A study testing Ketogenic diet with phytoextracts in people with Covid19, run by University of Padova at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Covid19
- What is being tested?
- Ketogenic diet with phytoextracts
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteItaly
- Study dates
- 1 Nov 2020to 30 Aug 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients hospitalized Hospital with COVID-19 diagnosis (nasopharyngeal and oropharyngeal swab)
- peripheral oxygen saturation higher tha 88%
Who cannot join
- intensive unit care
- under forced ventilation
- peripheral oxygen saturation lower than 88%
- parenteral nutrition
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
Ospedale San Bortolo
Vicenza, 36100
Lorenzo Cenci, MD, +393485405665
About this study
Official title: Pilot Study: Ketogenic Diet as Protective Factor During SARS-CoV-2 Infection
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
- Being tested
- Ketogenic diet with phytoextracts
- Keywords
- inflammation, cytokines, SARS-CoV-2, Ketogenic diet, ketosis
- Medical subject headings
- COVID-19, Inflammation, Ketosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ketogenic diet with phytoextractsDietary supplement
Patients were provided with an individualized nutritional ketogenic plan during hospitalization
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Dietary Supplement: Ketogenic diet with phytoextracts |
What is being measured
The primary outcome is the main question the study is designed to answer.
inflammation panel: interleukine 6 (IL-6)
change in IL-6 levels. IL-6 is an inflammatory cytokine. Units: in pg/mL
Measured: 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
Measured: 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
Measured: 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
Measured: 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)
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: Daily until patient's hospital discharge, up to 30 days
Oxygen saturation
change in basal peripheral oxygen saturation percentage (%)
Measured: Continuosly, daily until patient's hospital discharge, up to 30 days
Evaluation of Lungs conditions
Anteroposterior chest radiography (CXR)
Measured: 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.
Measured: up to 30 days
Secondary outcomes (9)
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
Measured: 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
Measured: 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
Measured: 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
Measured: 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)
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: Daily until patient's hospital discharge, up to 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2020
- Study start1 Nov 2020
- Primary completion30 Jul 2021 (estimated)
- Study completion30 Aug 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Covid19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 28 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Padova
- Sponsor type
- University, hospital or other
- Collaborators
- San Bortolo Hospital - Vicenza
- Responsible party
- Principal investigator, Antonio Paoli, University of Padova
- Investigators
- Antonio Paoli, MD, Principal investigator, University of Padova
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04615975
- Sponsor's protocol ID
- KDSARS0120
- Status last verified
- Nov 2020
- First submitted
- 31 Oct 2020
- Last updated
- 4 Nov 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study: Ketogenic Diet as Protective Factor During SARS-CoV-2 Infection
- ClinicalTrials.gov ID
- NCT04615975
- Acronym / sponsor ID
- KDSARS0120
- Conditions
- Covid19
- Keywords
- inflammation, cytokines, SARS-CoV-2, Ketogenic diet, ketosis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 28 participants (estimated)
- Lead sponsor
- University of PadovaUniversity, hospital or other
- Collaborators
- San Bortolo Hospital - Vicenza
- Study start
- 1 Nov 2020 (actual)
- Primary completion
- 30 Jul 2021 (estimated)
- Study completion
- 30 Aug 2021 (estimated)
- First posted
- 4 Nov 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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%.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Dietary Supplement: Ketogenic diet with phytoextractsPatients will receive 21 days of a very low carbohydrate mediterranean ketogenic diet with phytoextracts and 7 days of a low carbohydrate diet |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients hospitalized Hospital with COVID-19 diagnosis (nasopharyngeal and oropharyngeal swab)
- peripheral oxygen saturation higher tha 88%
Key exclusion criteria (4 listed)
- intensive unit care
- under forced ventilation
- peripheral oxygen saturation lower than 88%
- parenteral nutrition
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ketogenic diet with phytoextractsPatients were provided with an individualized nutritional ketogenic plan during hospitalization | Dietary supplement | Intervention |
Primary outcome
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.
9 secondary outcomes
Mean Corpuscular Hemoglobin (MCH)
Time frame: Daily until patient's hospital discharge, up to 30 days
Mean corpuscular volume (MCV)
Time frame: Daily until patient's hospital discharge, up to 30 days
mean corpuscular hemoglobin concentration (MCHC)
Time frame: Daily until patient's hospital discharge, up to 30 days
haemoglobin Hb
Time frame: Daily until patient's hospital discharge, up to 30 days
Red blood cells count
Time frame: Daily until patient's hospital discharge, up to 30 days
beta - hydroxybutyrate (BHB)
Time frame: Daily until patient's hospital discharge, up to 30 days
Alanine transaminase (ALT)
Time frame: Daily until patient's hospital discharge, up to 30 days
Aspartate transaminase (AST)
Time frame: Daily until patient's hospital discharge, up to 30 days
lactate dehydrogenase (LDH)
Time frame: Daily until patient's hospital discharge, up to 30 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Antonio Paoli, MD principal investigator
University of Padova
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ketogenic diet with phytoextracts in people with Covid19, run by University of Padova at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 4 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Antonio Paoli, MD (+393338911322, antonio.paoli@unipd.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
inflammation panel: interleukine 6 (IL-6) (time frame: Daily until patient's hospital discharge, up to 30 days). The study lists 12 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Nov 2020.