NCT06257641Completed
Impact of the Mediterranean Diet on Patients with Psoriasis
Impact of the Mediterranean Diet on Patients with Psoriasis: a Randomized Clinical Trial
Source: ClinicalTrials.gov · Last updated 21 Mar 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 38 (actual)
- First submitted
- 21 Jan 2024
- Start date
- 15 Feb 2024
- Primary completion date
- 15 Jan 2025
- Lead sponsor
- Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal
- NCT number
- NCT06257641
What you commit to
- Study type: Interventional
- Participants enrolled: 38
- From 15 Feb 2024 to the primary completion date, 15 Jan 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Participation in a clinical trial with drugs or dietary intervention in the year prior to inclusion in this study.
Other illness
- Type 1 or 2 diabetes mellitus.
- 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).
- Difficulty or inconvenience in changing dietary habits and following the Mediterranean diet (allergies, food intolerances, special diets).
Other
- Good adherence to the Mediterranean diet at the time of screening (er-MEDAS ≥8).
- Language barrier (patients not fluent in Spanish or English).
- Malnourished patients (screening using the Malnutrition Universal Screening Tool -MUST-, if indicated).
- Presenting gout.
- Pregnant, planning pregnancy or breastfeeding.
- Use of diuretics at the time of sampling.
- BMI greater than 40 kg/m2.
- Patients who during the recruitment period are expected to have poor collaboration, lack of commitment or real difficulties in following the development of the study.
Who the study is looking for
- 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.
Age in the registry: 18 years to 70 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Hospital Universitario Ramón y Cajal Coordinator of this site? Confirm its status | Madrid | Spain | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.