Mediterranean Diet for Psoriasis with Anti-IL-17 or Anti-IL-23 Inhibitors

This study is looking at whether following a Mediterranean Diet can help improve signs and symptoms of psoriasis in people who are also starting treatment with anti-IL-17 or anti-IL-23 inhibitor medications. You could be eligible if you are 18 to 94 years old, have chronic plaque psoriasis, and are about to start one of these specific psoriasis medications. The study aims to see if the diet changes certain blood cell profiles (monocytes and T-cells) after 10 weeks. The current status of this study is unclear, and it plans to enroll 36 participants.

Study design
This is an interventional study where participants will be randomly assigned to either follow a Mediterranean Diet or have no dietary intervention. It plans to enroll 36 participants.
What's involved
You will have 3 or 4 in-person visits over approximately 10 weeks. If you are using certain psoriasis medications, you may need a two-week break from them before starting the study.
Compensation
Not stated in the trial record.
Follow-up
Changes in blood cell profiles will be measured at baseline and after 10 weeks.

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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

Recruiting
NAAges 18–94InterventionalTreatment
University Hospitals Cleveland Medical Center
~36 participants
Updated 2026-06-03 on ClinicalTrials.gov
What's tested:Mediterranean Diet

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Percentage of participants who had a change in blood monocytes profiles.
Measured over Baseline, 10 weeks
+3 more outcomes measured
Psoriasis
1 sites across 1 states
Ohio1
  • Neil Korman, MD · PRINCIPAL_INVESTIGATOR · University Hospitals Cleveland Medical Center
  • Jordan K Kahle, MD · PRINCIPAL_INVESTIGATOR · University Hospitals Cleveland Medical Center

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Eligibility criteria

Inclusion

Diagnosis of chronic plaque psoriasis for at least 12 months prior to Screening.
Have moderate to severe plaque psoriasis at Baseline as defined by
Must have been prescribed, per standard-of-care, an Anti-IL-17 or Anti-IL-23 therapy for psoriasis, which the patient has not yet started, but is willing to start during the study.
Must be in good health (except for psoriasis) as judged by the Investigator, based on medical history and physical examination.
Must be eligible for a weight loss program, defined as being in good general health and having a BMI between 25 to 40.

Exclusion

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.
Pregnant or breast-feeding.
Have failed more than 3 systemic agents for treatment of psoriasis.
History of allergy to any component of Anti-IL-17 or Anti-IL-23 therapies.
Had a serious infection (including, but not limited to, hepatitis, pneumonia, sepsis, cellulitis, meningitis or pyelonephritis) or have been hospitalized for an infection. Subject must be cured of infection \> 4 weeks before Screening.
Have a history of, or ongoing, chronic or recurrent infectious disease, including, but not limited to, chronic renal infection, chronic chest infection (e.g., bronchiectasis), sinusitis, recurrent urinary tract infection (e.g., recurrent pyelonephritis, chronic non-remitting cystitis), an open, draining, or infected skin wound or ulcer.
Had a Bacillus Calmette-Guérin (BCG) vaccination within 1 year prior to screening.
History of positive human immunodeficiency virus (HIV), or have congenital or acquired immunodeficiency (e.g., common variable immunodeficiency disease).
Active substance abuse or a history of substance abuse within 6 months prior to Screening.
Bacterial infections requiring treatment with oral or injectable antibiotics, or significant viral or fungal infections, within 4 weeks of Screening. Any treatment and cure for such infections must have been completed at least 4 weeks prior to Screening.
Malignancy or history of malignancy, except for:
Have a known nut allergy.
Currently participating in a supervised dietary program.
Use of psoriasis therapy 2 weeks prior to Baseline (including, but not limited to, topical corticosteroids, retinoids or vitamin D analog preparations, tacrolimus, pimecrolimus, anthralin/dithranol, cyclosporine, corticosteroids, methotrexate, retinoids, mycophenolate, thioguanine, hydroxyurea, sirolimus, sulfasalazine, azathioprine, fumaric acid esters, TNF inhibitors IL-17 inhibitors, IL-12/23 inhibitors, or phototherapy).
Use of any investigational drug within 2 weeks prior to Baseline.
Prolonged sun exposure or use of tanning booths or other ultraviolet (UV) light sources.
Currently flaring or unstable psoriasis.
  • Percentage of participants who had a change in blood monocytes profiles.Baseline, 10 weeks
  • Percentage of participants who had a change in T-cell profiles.Baseline, 10 weeks
  • Change in blood monocyte profile.Baseline, 10 weeks
  • Change in T-cell profiles.Baseline, 10 weeks