NCT06399432

Mediterranean Diet vs no Dietary Intervention for Improving Signs and Symptoms of Psoriasis in Patients Treated With Anti-IL-17 or Anti-IL-23 Inhibitors

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 36 (estimated)
• Sponsor: University Hospitals Cleveland Medical Center · Academic / Other
• Sex: All
• Age: 18 Years – 94 Years
• Healthy volunteers: Not accepted

Summary

In this study, participants will have 3 or 4 total study visits over approximately 10 total weeks. There is a two week medication washout period in between the 1st and 2nd visits. This washout only applies if participants are using a prohibited psoriasis medication (such as topical steroids or oral psoriasis medications, like methotrexate). During the washout period, participants will have to stop the prohibited medication(s). If participants are not using any prohibited medications, then the 1st and 2nd visits can be combined and participants will only have 3 total in-person visits. Participants will be randomly assigned (by chance; like flipping a coin) to either the Mediterranean Diet or no dietary intervention. After 4 weeks on the diet, participants will start treatment with either Anti-IL-17 or Anti-IL-23 therapy. The biologic treatments will prescribed by the participants regular dermatologist and not as a part of the study.

Conditions

• Psoriasis

Interventions

Type	Name	Description
BEHAVIORAL	Mediterranean Diet	In the Mediterranean Diet, all foods are included. Red meat will be limited to 1/week, poultry to ≤3 times/week and fish to 2-3 times/week. Supplementation with extra-virgin olive oil and nuts, providing 1 liter of olive oil per week and 30 gr a day of nuts. The dietician will personalize the dietary advice by adapting it to the patient's condition, preferences and beliefs, will encourage adherence, and transmit a sense of empowerment. A change in diet with specific, attainable goals will be negotiated between the dietician and the participant. Dieticians will conduct a phone call once in every 2-week period to assess dietary compliance using a 24-hour food recall, the Mediterranean Diet Adherence Form. MD patients will keep a diet diary for 3 days every two weeks, which they will discuss with the dietician during their scheduled dietician assessment. The Baseline Visit with the dietician can occur either in-person or via video communication software.

Timeline

• Start date: 2022-10-18
• Primary completion: 2026-07-01
• Completion: 2026-07-01
• First posted: 2024-05-03
• Last updated: 2025-05-25

Locations

1 site across 1 country: United States