RecruitingNot Applicable

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

United States36 participantsStarted 2022-10-18

Plain-language summary

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.

Who can participate

Age range

18 Years – 94 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. BSA ≥5% OR
. sPGA ≥3 (moderate to severe) OR
. PASI ≥5

Exclusion criteria

. treated \[i.e., cured\] basal cell or squamous cell in situ skin carcinomas;
. 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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Percentage of participants who had a change in blood monocytes profiles.

Timeframe: Baseline, 10 weeks

Percentage of participants who had a change in T-cell profiles.

Timeframe: Baseline, 10 weeks

Change in blood monocyte profile.

Timeframe: Baseline, 10 weeks

Change in T-cell profiles.

Timeframe: Baseline, 10 weeks

Trial details

NCT IDNCT06399432

SponsorUniversity Hospitals Cleveland Medical Center

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-07-01

Contact for this trial

Kym Warner

216-844-7546 Kymberlyn.Warner@UHhospitals.org

View on ClinicalTrials.gov More Psoriasis trials

Plain-language summary

Who can participate

Age range

18 Years – 94 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. BSA ≥5% OR
. sPGA ≥3 (moderate to severe) OR
. PASI ≥5

Exclusion criteria

. treated \[i.e., cured\] basal cell or squamous cell in situ skin carcinomas;
. 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.

What they're measuring

Percentage of participants who had a change in blood monocytes profiles.

Timeframe: Baseline, 10 weeks

Percentage of participants who had a change in T-cell profiles.

Timeframe: Baseline, 10 weeks

Change in blood monocyte profile.

Timeframe: Baseline, 10 weeks

Change in T-cell profiles.

Timeframe: Baseline, 10 weeks