The Effect of Dietary Intervention on Endothelial Glycocalyx in Psoriasis

Sponsor

University of Athens (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05184699

Collaborator

(none)

Enrollment

Arms

9.9

Anticipated Duration (Months)

Study Details

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 psoriatic disease.

Condition or Disease	Intervention/Treatment	Phase
Psoriasis	Dietary Supplement: Food supplement Endocalyx Dietary Supplement: Placebo	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

60 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

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

Primary Purpose:

Prevention

Official Title:

The Effect of Dietary Intervention on Endothelial Glycocalyx Integrity and Microvascular Perfusion in Patients With Psoriatic Disease

Anticipated Study Start Date :

Sep 1, 2022

Anticipated Primary Completion Date :

Mar 1, 2023

Anticipated Study Completion Date :

Jun 30, 2023

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Food supplement Endocalyx 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 Patients with psoriatic disease will be randomized to receive food supplement Endocalyx for 4 months. Other Names: Endocalyx Q-prime
Placebo Comparator: Placebo Thirty patients with psoriatic disease will randomized to receive 4 capsules a day of the placebo for 4 months	Dietary Supplement: Placebo Patients with psoriatic disease will be randomized to receive placebo for 4 months.

Arm

Intervention/Treatment

Active Comparator: Food supplement Endocalyx

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

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

Other Names:

Endocalyx

Q-prime

Placebo Comparator: Placebo

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

Dietary Supplement: Placebo

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

Outcome Measures

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.

Secondary Outcome Measures

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 after bolus intravenous adenosine infusion to coronary flow velocity 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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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