Impact of the Mediterranean Diet on Patients with Psoriasis (NCT06257641) | Clinical Trial Compass
CompletedNot Applicable
Impact of the Mediterranean Diet on Patients with Psoriasis
Spain38 participantsStarted 2024-02-15
Plain-language summary
The goal of this clinical trial is to determine the effect of a high-intensity Mediterranean diet intervention over 16 weeks in a group of patients with mild to moderate psoriasis in terms of skin improvement as measured by PASI. In addition, the aim of this study will be to gather the necessary information for a larger and more extended clinical trial in the future.
Participants will be provided with dietary education for the implementation of the Mediterranean diet, supported by a monthly follow-up by nutritionists with experience in the field. Researchers will compare the effect of the Mediterranean diet on these patients to a control group provided with standard recommendations for a low-fat diet with no monitoring by nutritionists.
Who can participate
Age range
18 Years – 70 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Psoriasis clinically diagnosed by a dermatologist.
* Predominantly psoriasis vulgaris.
* Psoriasis Area and Severity Index (PASI) ≥2 and ≤ 10 at the time of recruitment.
* Stable weight (\< 5% weight loss or gain) in the last 3 months.
* Treated exclusively with topical treatment for psoriasis at enrolment and throughout the study.
* Able to give informed consent.
* Willing and able to follow the study procedure.
* Willing and able to attend all scheduled visits during the study period.
* Willing and able to provide blood samples as indicated in the procedure.
* Willing to implement pregnancy prevention measures throughout the study period.
Exclusion Criteria:
* Type 1 or 2 diabetes mellitus.
* Good adherence to the Mediterranean diet at the time of screening (er-MEDAS ≥8).
* Language barrier (patients not fluent in Spanish or English).
* Conditions that make telephone communication difficult (e.g. severe hearing loss).
* History of cardiac disease(s).
* Comorbidities that may compromise the implementation of the intervention (e.g. cancer, digestive diseases...) or limit survival to less than 6 months.
* History or current eating disorder (anorexia, bulimia, etc.; screening will be carried out using the Diagnostic and Statistical Manual of Mental Disorders, fifth edition, if indicated).
* Malnourished patients (screening using the Malnutrition Universal Screening Tool -MUST-, if indicated).
* Presenting gout.
* Pregnant, planning pregnancy or breastfe…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change from baseline in the Psoriasis Area and Severity Index (PASI) at week 16
Timeframe: Baseline and week 16
Trial details
NCT IDNCT06257641
SponsorFundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal