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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
36
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.
University Hospitals Cleveland Medical Center
Cleveland, Ohio, United States
RECRUITINGPercentage of participants who had a change in blood monocytes profiles.
Time frame: Baseline, 10 weeks
Percentage of participants who had a change in T-cell profiles.
Time frame: Baseline, 10 weeks
Change in blood monocyte profile.
Time frame: Baseline, 10 weeks
Change in T-cell profiles.
Time frame: Baseline, 10 weeks
Change in serum biomarkers.
Time frame: Baseline, 10 weeks
Change in gut microbiome.
Time frame: Baseline, 10 weeks
Change in single cell gene expression.
Time frame: Baseline, 10 weeks
Change in metabolomics profile.
Time frame: Baseline, 10 weeks
Change in serum chemistries.
Time frame: Baseline, 10 weeks
Change in complete blood cell count.
Time frame: Baseline, 10 weeks
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