PsoriasisNCT05184699
The Effect of Dietary Intervention on Endothelial Glycocalyx in Psoriasis
A study testing Food supplement Endocalyx in people with Psoriasis, run by University of Athens at 1 site in Greece.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Psoriasis
- What is being tested?
- Food supplement Endocalyx
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteGreece
- Study dates
- 1 Nov 2022to 30 Jan 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
Greece1 site, 1 recruiting
- Recruiting
Attikon University Hospital
Athens, Attica, 12462
Ignatios Ikonomidis, Professor, +302105832187, ignoik@gmail.com
George Pavlidis, PhD, +302105832187, geo_pavlidis@yahoo.gr
About this study
Official title: The Effect of Dietary Intervention on Endothelial Glycocalyx Integrity and Microvascular Perfusion in Patients With Psoriatic Disease
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.
Read the 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.
- Conditions
- Psoriasis
- Being tested
- Food supplement Endocalyx, Placebo
- Keywords
- psoriasis, endothelial glycocalyx, arterial stiffness, coronary microcirculation, left ventricular myocardial deformation
- Medical subject headings
- Psoriasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Food supplement EndocalyxDietary supplement
Also called Endocalyx, Q-prime
Patients with psoriatic disease will be randomized to receive food supplement Endocalyx for 4 months.
PlaceboDietary supplement
Patients with psoriatic disease will be randomized to receive placebo for 4 months.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: four months
Secondary outcomes (3)
Endocalyx effects on arterial stiffness
Endocalyx effects on arterial stiffness as assessed by carotid to femoral pulse wave velocity (PWV, m/s) using tonometry.
Measured: four months
Endocalyx effects on coronary microcirculation
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.
Measured: four months
Endocalyx effects on left ventricular myocardial function
Endocalyx effects on left ventricular function as assessed by global longitudinal strain using speckle-tracking echocardiography.
Measured: four months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2022
- Study start1 Nov 2022
- Primary completion1 Nov 2023 (estimated)
- Study completion30 Jan 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for PsoriasisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Athens
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ignatios Ikonomidis, University of Athens
- Investigators
- Ignatios Ikonomidis, Professor, Principal investigator, 2nd Cardiology Department, National and Kapodistrian University of Athens
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05184699
- Sponsor's protocol ID
- 672/2-12-2021
- Status last verified
- May 2023
- First submitted
- 20 Dec 2021
- Last updated
- 16 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 39125451
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Dietary Intervention on Endothelial Glycocalyx Integrity and Microvascular Perfusion in Patients With Psoriatic Disease
- ClinicalTrials.gov ID
- NCT05184699
- Acronym / sponsor ID
- 672/2-12-2021
- Conditions
- Psoriasis
- Keywords
- psoriasis, endothelial glycocalyx, arterial stiffness, coronary microcirculation, left ventricular myocardial deformation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University of AthensUniversity, hospital or other
- Study start
- 1 Nov 2022 (actual)
- Primary completion
- 1 Nov 2023 (estimated)
- Study completion
- 30 Jan 2024 (estimated)
- First posted
- 11 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Food supplement Endocalyx | Active comparator | Dietary Supplement: Food supplement EndocalyxThirty patients with psoriatic disease will randomized to receive 4 capsules a day of the food supplement Endocalyx for 4 months |
| Placebo | Placebo comparator | Dietary Supplement: PlaceboThirty patients with psoriatic disease will randomized to receive 4 capsules a day of the placebo for 4 months |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Food supplement EndocalyxAlso: Endocalyx, Q-primePatients with psoriatic disease will be randomized to receive food supplement Endocalyx for 4 months. | Dietary supplement | Food supplement Endocalyx |
| PlaceboPatients with psoriatic disease will be randomized to receive placebo for 4 months. | Dietary supplement | Placebo |
Primary outcome
Endocalyx effects on endothelial glycocalyx thickness
Time frame: 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.
3 secondary outcomes
Endocalyx effects on arterial stiffness
Time frame: four months
Endocalyx effects on coronary microcirculation
Time frame: four months
Endocalyx effects on left ventricular myocardial function
Time frame: four months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2023.
- Derived from this study: PubMed 39125451Ikonomidis 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ignatios Ikonomidis, Professor principal investigator
2nd Cardiology Department, National and Kapodistrian University of Athens
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Food supplement Endocalyx in people with Psoriasis, run by University of Athens at 1 site in Greece.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Greece. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ignatios Ikonomidis, Professor (+302105832187, ignoik@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Endocalyx effects on endothelial glycocalyx thickness (time frame: four months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05184699, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 May 2023.