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Can olive oil and nuts tame psoriasis? new study tests diet plus biologics

NCT ID NCT06399432

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

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

About 36 people

The number the study aims to enrol. It can still change while the study runs.

Started

Oct 2022

Expected to finish

Jan 2027

An estimate. End dates often move.

Lead sponsor

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

18 to 94 years

Sex

Anyone

Healthy volunteers

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

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.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

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Contacts and locations

Locations

  • University Hospitals Cleveland Medical Center

    RECRUITING

    Cleveland, Ohio, 44106, United States

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