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Ketogenic Diet as Protective Factor During COVID-19

NCT ID: NCT04615975

Last Updated: 2020-11-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

28 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-11-01

Study Completion Date

2021-08-30

Brief Summary

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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

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Conditions

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Covid19

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Intervention

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

Group Type EXPERIMENTAL

Ketogenic diet with phytoextracts

Intervention Type DIETARY_SUPPLEMENT

Patients were provided with an individualized nutritional ketogenic plan during hospitalization

Interventions

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Ketogenic diet with phytoextracts

Patients were provided with an individualized nutritional ketogenic plan during hospitalization

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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San Bortolo Hospital - Vicenza

UNKNOWN

Sponsor Role collaborator

University of Padova

OTHER

Sponsor Role lead

Responsible Party

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Antonio Paoli

Full Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Antonio Paoli, MD

Role: PRINCIPAL_INVESTIGATOR

University of Padova

Locations

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Ospedale San Bortolo

Vicenza, , Italy

Site Status RECRUITING

Countries

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Italy

Central Contacts

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Antonio Paoli, MD

Role: CONTACT

[email protected]
+393338911322

Facility Contacts

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Lorenzo Cenci, MD

Role: primary

+393485405665

Other Identifiers

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KDSARS0120

Identifier Type: -

Identifier Source: org_study_id