The Effect of Dietary Intervention on Endothelial Glycocalyx in Psoriasis

Not Applicable

Recruiting

• Conditions: Psoriasis

• Registration Number: NCT05184699
• 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 psoriatic disease.

Detailed Description

Sixty patients with psoriatic disease, who are referred to the outpatient psoriasis clinic of the Attikon University Hospital, 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: 2021-12-20
• Study First Submitted QC: 2022-01-07
• Study First Posted: 2022-01-11
• Study Start: 2022-11-01
• 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 with psoriatic disease (plaque-type psoriasis or psoriatic arthritis)
• Body mass index ≥18.5 Kg/m2
• If female, patients must be non-pregnant and non-breastfeeding

Exclusion Criteria

• 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
• Liver failure
• Malignancies

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

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 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 after bolus intravenous adenosine infusion to coronary flow velocity at rest.
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 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 Hospital; 🇬🇷 Athens, Attiki, Greece