The Effect of Dietary Intervation on Endothelial Glycocalyx in COVID-19 Patients.

COVID-19 Clinical Trial

Official title:

The Effect of Dietary Glycocalyx Precursor Supplementation on Endothelial Function, on Markers of Vascular Function and on Cardiac Performance in Patients With COVID-19 Infection.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05185934
• Other study ID #: 668/30-11-2021
• Status: Recruiting
• Phase: N/A
• Start date: June 1, 2022
• Est. completion date: January 30, 2024

Study information

• Verified date: May 2023
• Source: University of Athens
• Contact: Ignatios Ikonomidis, Professor
• Phone: +302105832187
• Email: ignoik[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The food supplement Endocalyx is considered to support the endothelial glycocalyx integrity by supplying sulfated polysaccharides, anti-oxidant enzymes and additional substrates for glycocalyx synthesis. The investigators will study the effect of Endocalyx on endothelial, vascular and left ventricular myocardial function in patients with COVID-19 infection.

Description:

Sixty patients who have been hospitalized due to COVID-19 infection will be randomized to receive food supplement Endocalyx (4 capsules per day) (n=30) or placebo (n=30) for 4 consecutive months.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: January 30, 2024
• Est. primary completion date: November 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• caucasian patients

• hospitalization for COVID-19 infection

• diagnosis of COVID-19 proven by PCR

Exclusion Criteria:

• Pregnancy and breastfeeding

• Foreseen inability to attend scheduled visits

• History of acute coronary syndrome. Coronary artery disease will be excluded by a clinical history, examination and electrocardiogram.

• Moderate or severe valve disease

• Primary cardiomyopathies

• Chronic obstructive pulmonary disease

• Asthma

• Chronic kidney disease (estimated glomerular filtration rate [eGFR] =60 ml/min/1.73 m2)

• Liver failure

• Malignancies

Related Conditions & MeSH terms

• COVID-19
• Endothelial Dysfunction

Intervention

Dietary Supplement:
• Food supplement Endocalyx
Patients with COVID-19 infection will be randomized to receive food supplement Endocalyx for 4 months.
• Placebo
Patients with COVID-19 infection will be randomized to receive placebo for 4 months.

Locations

Country	Name	City	State
Greece	"Attikon" University General Hospital	Athens	Attiki

Sponsors (1)

Lead Sponsor	Collaborator
University of Athens

Country where clinical trial is conducted

Greece, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Endocalyx effects on endothelial glycocalyx thickness	Endocalyx effects on endothelial glycocalyx thickness as assessed by perfused boundary region (PBR, micrometers) of the sublingual arterial microvessels using Sidestream Dark Field (SDF) imaging	four months
Secondary	Endocalyx effects on arterial stiffness	Endocalyx effects on arterial stiffness as assessed by carotid to femoral pulse wave velocity (PWV, m/s) using tonometry.	four months
Secondary	Endocalyx effects on coronary microcirculation	Endocalyx effects on coronary function as assessed by measuring coronary flow reserve of left anterior descending artery. Coronary flow reserve is estimated by Doppler echocardiography as the ratio of coronary flow velocity (m/s) after bolus intravenous adenosine infusion to coronary flow velocity (m/s) at rest.	four months
Secondary	Endocalyx effects on left ventricular myocardial function	Endocalyx effects on left ventricular function as assessed by global longitudinal strain using speckle-tracking echocardiography.	four months