NCT06257641

Impact of the Mediterranean Diet on Patients with Psoriasis

Impact of the Mediterranean Diet on Patients with Psoriasis: a Randomized Clinical Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 38 (actual)
• Sponsor: Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Detailed description

MEDIPSO is an experimental, randomised, controlled, open-label, single-blinded (evaluator) study. It is a clinical trial in which patients with mild to moderate psoriasis with stable topical treatment are randomly assigned to either the control group or the intervention group. Patients assigned to the intervention group will undergo dietary education for the adoption of the Mediterranean diet, with monthly monitoring - mostly online - by nutritionists with experience in the field. In both groups, blood tests with metabolic parameters will be obtained before and after the study period, and data of anthropometric characteristics and quality of life will be assessed. The effect of the intervention on skin involvement, metabolic parameters and inflammatory cytokines will be assessed, and the emotional and quality of life impact will also be investigated. In addition, a methodological analysis will be carried out in order to improve the design for a larger scale clinical trial in the future.

Conditions

• Psoriasis
• Psoriasis Vulgaris
• Hyperlipidemias
• Depression
• Anxiety
• Metabolic Syndrome
• Obesity

Interventions

Type	Name	Description
OTHER	High-intensity Mediterranean diet intervention	Dietary education for the adoption of the Mediterranean diet, with monthly monitoring - mostly online - by nutritionists with experience in the field. Patients will be given 500 ml of extra virgin olive oil per week and informative material about the Mediterranean diet, as well as recipes and weekly menus.

Timeline

• Start date: 2024-02-15
• Primary completion: 2025-01-15
• Completion: 2025-03-10
• First posted: 2024-02-14
• Last updated: 2025-03-21

Locations

1 site across 1 country: Spain