Can olive oil and nuts tame psoriasis? new study tests diet plus biologics
NCT ID NCT06399432
First seen Jun 26, 2026 · Last updated Sep 04, 2026 · Updated 2 times
Summary
This study tests whether adding a Mediterranean diet (rich in olive oil, nuts, fish, and limited red meat) improves psoriasis symptoms in 36 adults who are about to start biologic therapy (Anti-IL-17 or Anti-IL-23 drugs). Participants are randomly assigned to either follow the diet or receive no dietary advice for about 10 weeks. The goal is to see if the diet changes immune cell profiles and other markers of inflammation.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Mediterranean diet (behavioral intervention)
- What this could lead to
- If it works, this could show that adding a Mediterranean diet to standard biologic therapy improves psoriasis symptoms more than medication alone.
- What could go wrong
- This is a small, early-stage trial with only 36 participants. The diet is not a standalone treatment, and results may not apply to everyone with psoriasis.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 36 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Oct 2022
- Expected to finish
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Jan 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 94 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Diagnosis of chronic plaque psoriasis for at least 12 months prior to Screening. * Have moderate to severe plaque psoriasis at Baseline as defined by 1. BSA ≥5% OR 2. sPGA ≥3 (moderate to severe) OR 3. PASI ≥5 * 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. Eligible therapies are Secukinumab, Ixekizumab, Brodalumab, Guselkumab, Risankizumab, and Tildrakizumab. * 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 Criteria: * 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: 1. treated \[i.e., cured\] basal cell or squamous cell in situ skin carcinomas; 2. treated \[i.e., cured\] cervical intraepithelial neoplasia \[CIN\] or carcinoma in situ of the cervix with no evidence of recurrence within the previous 5 years. * 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). Exceptions: Low-potency corticosteroids will be allowed as background therapy and restricted to treatment of the face, axillae, and groin in accordance with the manufacturers' suggested usage during the course of the study (this restricted usage should be documented). Subjects with scalp psoriasis will be permitted to use coal tar shampoo and/or salicylic acid scalp preparations on scalp lesions. An unmedicated skin moisturizer (e.g. Eucerin®) will be also permitted for body lesions only. Subjects should not use these topical treatments within 24 hours prior to the clinic visit. * 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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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University Hospitals Cleveland Medical Center
RECRUITINGCleveland, Ohio, 44106, United States
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