The Effect of Dietary Intervention on Endothelial Glycocalyx in Psoriasis

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-11-01

Study Completion Date

2024-01-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Psoriasis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Food supplement Endocalyx

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

Group Type ACTIVE_COMPARATOR

Food supplement Endocalyx

Intervention Type DIETARY_SUPPLEMENT

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

Placebo

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

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DIETARY_SUPPLEMENT

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

Interventions

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Food supplement Endocalyx

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

Intervention Type DIETARY_SUPPLEMENT

Placebo

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

Intervention Type DIETARY_SUPPLEMENT

Other Intervention Names

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Endocalyx Q-prime

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No