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

Primary Purpose

COVID-19, Endothelial Dysfunction

Status
Recruiting
Phase
Not Applicable
Locations
Greece
Study Type
Interventional
Intervention
Food supplement Endocalyx
Placebo
Sponsored by
University of Athens
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for COVID-19 focused on measuring COVID-19, Arterial Stiffness, Endothelial Glycocalyx, Coronary microcirculation, Left ventricular myocardial deformation

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • "Attikon" University General HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Food supplement Endocalyx

Placebo

Arm Description

Thirty patients with COVID-19 infection will randomized to receive 4 capsules a day of the food supplement Endocalyx for 4 months.

Thirty patients with COVID-19 infection will randomized to receive 4 capsules a day of the placebo for 4 months.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
January 9, 2022
Last Updated
May 14, 2023
Sponsor
University of Athens
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1. Study Identification

Unique Protocol Identification Number
NCT05185934
Brief Title
The Effect of Dietary Intervation on Endothelial Glycocalyx in COVID-19 Patients.
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.
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 1, 2022 (Actual)
Primary Completion Date
November 1, 2023 (Anticipated)
Study Completion Date
January 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Athens

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COVID-19, Endothelial Dysfunction
Keywords
COVID-19, Arterial Stiffness, Endothelial Glycocalyx, Coronary microcirculation, Left ventricular myocardial deformation

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Sixty patients with COVID-19 infection will be randomized to receive food supplement Endocalyx (n=30) or placebo (n=30) for 4 consecutive months.
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Food supplement Endocalyx
Arm Type
Active Comparator
Arm Description
Thirty patients with COVID-19 infection will randomized to receive 4 capsules a day of the food supplement Endocalyx for 4 months.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Thirty patients with COVID-19 infection will randomized to receive 4 capsules a day of the placebo for 4 months.
Intervention Type
Dietary Supplement
Intervention Name(s)
Food supplement Endocalyx
Intervention Description
Patients with COVID-19 infection will be randomized to receive food supplement Endocalyx for 4 months.
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo
Intervention Description
Patients with COVID-19 infection will be randomized to receive placebo for 4 months.
Primary Outcome Measure Information:
Title
Endocalyx effects on endothelial glycocalyx thickness
Description
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
Time Frame
four months
Secondary Outcome Measure Information:
Title
Endocalyx effects on arterial stiffness
Description
Endocalyx effects on arterial stiffness as assessed by carotid to femoral pulse wave velocity (PWV, m/s) using tonometry.
Time Frame
four months
Title
Endocalyx effects on coronary microcirculation
Description
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.
Time Frame
four months
Title
Endocalyx effects on left ventricular myocardial function
Description
Endocalyx effects on left ventricular function as assessed by global longitudinal strain using speckle-tracking echocardiography.
Time Frame
four months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ignatios Ikonomidis, Professor
Phone
+302105832187
Email
ignoik@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Aikaterini Kountouri, MD
Phone
+302105832187
Email
KaterinaK90@hotmail.com
Facility Information:
Facility Name
"Attikon" University General Hospital
City
Athens
State/Province
Attiki
ZIP/Postal Code
12462
Country
Greece
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ignatios Ikonomidis, Professor
Phone
+302105832187
Email
ignoik@gmail.com
First Name & Middle Initial & Last Name & Degree
Aikaterini Kountouri, MD
Phone
+302105832187
Email
KaterinaK90@hotmail.com

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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