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

Not Applicable

Recruiting

• Conditions: Endothelial Dysfunction; COVID-19
• Interventions: Dietary Supplement: Food supplement Endocalyx; Dietary Supplement: Placebo

• Registration Number: NCT05185934
• Lead Sponsor: University of Athens

Brief 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.

Detailed 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.

Study Timeline

• Study First Submitted: 2022-01-09
• Study First Submitted QC: 2022-01-09
• Study First Posted: 2022-01-11
• Study Start: 2022-06-01
• Status Verified: 2023-05
• Last Update Submitted: 2023-05-14
• Last Update Posted: 2023-05-16
• Primary Completion: 2023-11-01
• Study Completion: 2024-01-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Food supplement Endocalyx	Food supplement Endocalyx	Thirty patients with COVID-19 infection will randomized to receive 4 capsules a day of the food supplement Endocalyx for 4 months.
Placebo	Placebo	Thirty patients with COVID-19 infection will randomized to receive 4 capsules a day of the placebo for 4 months.

Primary Outcome Measures

Name	Time	Method
Endocalyx effects on endothelial glycocalyx thickness	four months	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

Secondary Outcome Measures

Name	Time	Method
Endocalyx effects on arterial stiffness	four months	Endocalyx effects on arterial stiffness as assessed by carotid to femoral pulse wave velocity (PWV, m/s) using tonometry.
Endocalyx effects on coronary microcirculation	four months	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.
Endocalyx effects on left ventricular myocardial function	four months	Endocalyx effects on left ventricular function as assessed by global longitudinal strain using speckle-tracking echocardiography.

Trial Locations

Locations (1)

"Attikon" University General Hospital; 🇬🇷 Athens, Attiki, Greece