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Behavioral Intervention

Mediterranean Diet for Psoriasis

N/A

Recruiting

Led By Jordan K Kahle, MD

Research Sponsored by Neil Korman

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Diagnosis of chronic plaque psoriasis for at least 12 months prior to Screening

Have moderate to severe plaque psoriasis at Baseline as defined by BSA ≥5%, sPGA ≥3 (moderate to severe), or PASI ≥5

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, 10 weeks

Awards & highlights

Study Summary

This trial will last for about 10 weeks and participants will have 3 or 4 in-person visits. If participants are using prohibited psoriasis medications, there will be a two-week period where they

Who is the study for?

This trial is for individuals with psoriasis who are starting or already receiving Anti-IL-17 or Anti-IL-23 inhibitors. Participants must be willing to potentially change their diet and not use certain psoriasis medications like topical steroids or methotrexate during a two-week washout period.Check my eligibility

What is being tested?

The study is testing if following a Mediterranean Diet can improve the symptoms of psoriasis compared to no dietary changes, in patients treated with biologic therapies targeting IL-17 or IL-23.See study design

What are the potential side effects?

Since this trial involves dietary changes rather than medication, side effects may include typical reactions to changing one's diet such as digestive discomfort. The biologic treatments have their own side effects which are not part of this study.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have been diagnosed with chronic plaque psoriasis for over a year.

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I have moderate to severe plaque psoriasis.

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I am in good health with a BMI between 25 to 40.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, 10 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, 10 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 10 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change in T-cell profiles.

Change in blood monocyte profile.

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

+1 more

Secondary outcome measures

Change in complete blood cell count.

Change in gut microbiome.

Change in metabolomics profile.

+3 more

Trial Design

2Treatment groups

Active Control

Group I: Mediterranean DietActive Control1 Intervention

Participants in this arm will follow the Mediterranean Diet.

Group II: No Dietary InterventionActive Control1 Intervention

Participants in this arm will have no dietary intervention.

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

Neil KormanLead Sponsor

Jordan K Kahle, MDPrincipal InvestigatorUniversity Hospitals Cleveland Medical Center

Neil Korman, MDPrincipal InvestigatorUniversity Hospitals Cleveland Medical Center

5 Previous Clinical Trials

122 Total Patients Enrolled

3 Trials studying Psoriasis

54 Patients Enrolled for Psoriasis

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Am I eligible to enroll in this medical research study?

"To qualify for participation in this study, individuals must have a diagnosis of psoriasis and be between 18 and 94 years old. The trial aims to enroll approximately 36 eligible participants."

Answered by AI

Are potential participants currently able to join this research study?

"The search for suitable participants is ongoing according to information found on clinicaltrials.gov. Initial posting of the trial occurred on October 18, 2022, with the most recent update documented on April 30, 2024."

Answered by AI

How large is the overall participant population involved in this research endeavor?

"Indeed, the information on clinicaltrials.gov highlights that this particular medical research is actively seeking eligible individuals. The trial was initially published on October 18th, 2022 and its most recent update was made on April 30th, 2024. This study aims to recruit a total of 36 participants from one designated site."

Answered by AI

Does the trial include participants older than 70 years of age?

"The requirements for participation in this study specify that individuals aged between 18 and 94 are eligible. It is noteworthy that there exist 23 investigations targeting participants under the age of 18 and an additional 142 studies focusing on those above 65 years old."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

Neil Korman 2022. "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". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06399432.

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