The Effect of Dietary Intervention on Endothelial Glycocalyx in Psoriasis

National and Kapodistrian University of Athens

Status: Enrolling

Conditions: Psoriasis

Treatments: Dietary Supplement: Placebo; Dietary Supplement: Food supplement Endocalyx

Study type: Interventional

Funder types: Other

Identifiers

NCT05184699

672/2-12-2021

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No 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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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60 participants in 2 patient groups, including a placebo group

Food supplement Endocalyx

Active Comparator group

Description:

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

Treatment:

Dietary Supplement: Food supplement Endocalyx

Placebo

Placebo Comparator group

Description:

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

Treatment:

Dietary Supplement: Placebo