The Effect of Dietary Intervention on Endothelial Glycocalyx in Psoriasis

NCT05184699 | Unknown

• 1 other identifier: 672/2-12-2021
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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

Keywords

psoriasis; endothelial glycocalyx; arterial stiffness; coronary microcirculation; left ventricular myocardial deformation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Endocalyx effects on arterial stiffness

  four months

• Endocalyx effects on coronary microcirculation

  four months

• Endocalyx effects on left ventricular myocardial function

  four months

Study Arms (2)

Food supplement Endocalyx

ACTIVE COMPARATOR

Thirty patients with psoriatic disease will randomized to receive 4 capsules a day of the food supplement Endocalyx for 4 months

Dietary Supplement: Food supplement Endocalyx

Placebo

PLACEBO COMPARATOR

Thirty patients with psoriatic disease will randomized to receive 4 capsules a day of the placebo for 4 months

Dietary Supplement: Placebo

Interventions

Food supplement Endocalyx DIETARY_SUPPLEMENT

Patients with psoriatic disease will be randomized to receive food supplement Endocalyx for 4 months.

Also known as: Endocalyx, Q-prime

Food supplement Endocalyx

Placebo DIETARY_SUPPLEMENT

Patients with psoriatic disease will be randomized to receive placebo for 4 months.

Placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Athens: lead

Study Sites (1)

Attikon University Hospital

Athens, Attica, 12462, Greece

RECRUITING

Related Publications (1)

• Ikonomidis I, Katsanaki E, Thymis J, Pavlidis G, Lampadaki K, Katogiannis K, Vaiopoulos A, Lazarou V, Kostelli G, Michalopoulou E, Pililis S, Vlachomitros D, Theodoropoulos K, Vink H, Long R, Papadavid E, Lambadiari V. The Effect of 4-Month Treatment with Glycocalyx Dietary Supplement on Endothelial Glycocalyx Integrity and Vascular Function in Patients with Psoriasis. Nutrients. 2024 Aug 5;16(15):2572. doi: 10.3390/nu16152572.

  PMID: 39125451 DERIVED

MeSH Terms

Conditions

Psoriasis

Condition Hierarchy (Ancestors)

Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Ignatios Ikonomidis, Professor

  2nd Cardiology Department, National and Kapodistrian University of Athens

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ignatios Ikonomidis, Professor

CONTACT

+302105832187; ignoik@gmail.com

George Pavlidis, PhD

CONTACT

+302105832187; geo_pavlidis@yahoo.gr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Cardiology

Model Details: Sixty patients with psoriatic disease will be randomized to receive food supplement Endocalyx (n=30) or placebo (n=30) for 4 consecutive months.

Study Record Dates

• First Submitted: December 20, 2021
• First Posted: January 11, 2022
• Study Start: November 1, 2022
• Primary Completion: November 1, 2023
• Study Completion: January 30, 2024
• Last Updated: May 16, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

GR (1)