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.
Diagnosis of chronic plaque psoriasis for at least 12 months prior to Screening.
Have moderate to severe plaque psoriasis at Baseline as defined by
BSA ≥5% OR
sPGA ≥3 (moderate to severe) OR
Other than psoriasis, history of any clinically significant (as determined by the Investigator) cardiac (clinically advanced cardiovascular disease including stent, past history of MI, thrombotic event or arterial calcification), active or history of inflammatory bowel disease, endocrinologic, pulmonary, neurologic, psychiatric, hepatic, renal, hematologic, immunologic disease, or other major uncontrolled disease.
Any condition, including the presence of laboratory abnormalities, which would place the subject at unacceptable risk if he/she were to participate in the study.
Any condition, including other inflammatory diseases or dermatologic conditions that confound the ability to interpret data from the study.
Prior history of suicide attempt at any time in the subject's lifetime prior to screening or randomization, or major psychiatric illness requiring hospitalization within the last 3 years.
Parallel
Mediterranean Diet
BehavioralIn 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.
Percentage of participants who had a change in blood monocytes profiles.
Percentage of participants who had a change in T-cell profiles.
Change in blood monocyte profile.
Change in T-cell profiles.
Change in serum biomarkers.
Change in gut microbiome.
Change in single cell gene expression.
Change in metabolomics profile.
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