Interventional Recruiting
NCT05184699 on ClinicalTrials.gov
The Effect of Dietary Intervention on Endothelial Glycocalyx in Psoriasis
Official title: The Effect of Dietary Intervention on Endothelial Glycocalyx Integrity and Microvascular Perfusion in Patients With Psoriatic Disease
- Sponsor: National and Kapodistrian University of Athens
- Enrollment: 60 (Estimated)
- Study start: 2022-11-01 (Actual)
- Primary completion: 2023-11-01 (Estimated)
- Study completion: 2024-01-30 (Estimated)
- Allocation: Randomized
- InterventionModel: Parallel
- InterventionModelDescription: Sixty patients with psoriatic disease will be randomized to receive food supplement Endocalyx (n=30) or placebo (n=30) for 4 consecutive months.
- Masking: Double (Participant, Investigator)
- PrimaryPurpose: Prevention
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.
Conditions
- Psoriasis
Intervention / Treatment
- Dietary Supplement: Food supplement Endocalyx
- Dietary Supplement: Placebo
Primary Outcome Measures
-
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.
Countries
Greece
Locations and Investigators
-
Attikon University Hospital, Athens, Greece (Recruiting)
- Ignatios Ikonomidis, Professor
- George Pavlidis, PhD
Study Officials
- Ignatios Ikonomidis, Professor (Principal Investigator) — 2nd Cardiology Department, National and Kapodistrian University of Athens