Mediterranean Diet for Psoriasis

Overseen By Kym Warner

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Neil Korman

Must be taking: Anti-IL-17, Anti-IL-23

Must not be taking: Psoriasis therapies, TNF inhibitors

Disqualifiers: Cardiovascular disease, Inflammatory bowel, Psychiatric, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

Duration: 4 weeks

36 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether a Mediterranean Diet can improve symptoms for people with plaque psoriasis, a skin condition that causes red, scaly patches. Participants will be randomly assigned to either follow the diet or make no dietary changes before starting a specific psoriasis treatment. Eligible participants should have moderate to severe plaque psoriasis and be about to begin treatments such as Anti-IL-17 or Anti-IL-23 therapies.

As an unphased trial, this study offers a unique opportunity to explore dietary impacts on psoriasis, potentially improving participants' quality of life.

Will I have to stop taking my current medications?

You may need to stop taking certain psoriasis medications, like topical steroids or oral medications such as methotrexate, for a two-week period if they are prohibited in the study. If you are not using any prohibited medications, you won't need to stop your current medications.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that the Mediterranean Diet might be safe and helpful for people with psoriasis. One study found that following this diet for 16 weeks not only reduced psoriasis symptoms but also improved overall health. This suggests the diet is easy to follow and doesn't cause harmful side effects.

In that study, 47.4% of participants on the Mediterranean Diet experienced significant improvement in their psoriasis symptoms, while none in the control group did. This improvement suggests the diet is a safe choice for many people.

Overall, the research supports the idea that the Mediterranean Diet is both safe and potentially beneficial for those with psoriasis. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Mediterranean Diet for psoriasis because it offers a unique approach compared to standard treatments like topical steroids, phototherapy, and systemic medications. Unlike these conventional therapies, which often focus on reducing inflammation or suppressing the immune system, the Mediterranean Diet emphasizes whole foods like fruits, vegetables, whole grains, and healthy fats. This diet has the potential to improve overall health and reduce inflammation naturally, which could lead to a decrease in psoriasis symptoms without the side effects associated with medications. Additionally, adopting this diet could provide long-term benefits for heart health and weight management, which are often concerns for those with psoriasis.

What evidence suggests that the Mediterranean Diet might be an effective treatment for psoriasis?

Research has shown that the Mediterranean diet can greatly help with psoriasis symptoms. In a 16-week study, participants who followed this diet experienced a significant reduction in the severity of their psoriasis. Nearly half of them saw a 75% improvement in their Psoriasis Area and Severity Index (PASI) score, which measures psoriasis severity. This trial will compare participants following the Mediterranean diet with those receiving no dietary intervention. These findings suggest that the Mediterranean diet could effectively manage psoriasis symptoms. ^{1 2 3 4 6}

Who Is on the Research Team?

Neil Korman

Principal Investigator

University Hospitals Cleveland Medical Center

Jordan Kahle, MD

Principal Investigator

University Hospitals Cleveland Medical Center

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

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

Must be in good health (except for psoriasis) as judged by the Investigator, based on medical history and physical examination

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

Exclusion Criteria

Pregnant or breast-feeding

Any condition or laboratory abnormalities that would place the subject at unacceptable risk if he/she were to participate in 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

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2 weeks

1 visit (in-person)

Dietary Intervention

Participants are randomly assigned to either the Mediterranean Diet or no dietary intervention for 4 weeks

4 weeks

1 visit (in-person)

Washout

Two-week washout period for participants using prohibited psoriasis medications

2 weeks

No visits

Treatment

Participants start treatment with either Anti-IL-17 or Anti-IL-23 therapy

4 weeks

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Mediterranean Diet

Trial Overview 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.

How Is the Trial Designed?

Group I: No Dietary Intervention Active Control 1 Intervention

Participants in this arm will have no dietary intervention.

Group II: Mediterranean Diet Active Control 1 Intervention

Participants in this arm will follow the Mediterranean Diet.

Who Is Running the Clinical Trial?

Neil Korman

Lead Sponsor

Trials

1

Recruited

40+

University Hospitals Cleveland Medical Center

Lead Sponsor

Trials

348

Recruited

394,000+

Published Research Related to This Trial

A healthy lifestyle, including maintaining a proper body weight and engaging in physical activity, can significantly improve the severity of psoriasis, as shown in a review of studies linking psoriasis with metabolic disorders and nutritional treatments.

Adopting a Mediterranean diet, which is rich in fiber, vitamins, and polyphenols, may help control psoriasis symptoms due to its anti-inflammatory effects and positive influence on gut health, making it a beneficial complement to standard psoriasis therapies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Metabolic Disorders and Psoriasis: Exploring the Role of Nutritional Interventions. Cintoni, M., Palombaro, M., Maramao, FS., et al.[2023]

Patients with psoriasis showed significantly lower adherence to the Mediterranean diet compared to healthy controls, which was associated with higher severity of the disease as measured by the Psoriasis Area and Severity Index (PASI) score.

The study found that body fat percentage and adherence to the Mediterranean diet, particularly the consumption of extra virgin olive oil and fish, were significant predictors of psoriasis severity and inflammation levels, indicating that dietary patterns may influence the condition.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Nutrition and psoriasis: is there any association between the severity of the disease and adherence to the Mediterranean diet? Barrea, L., Balato, N., Di Somma, C., et al.[2022]

Lifestyle factors such as diet, physical activity, and avoiding alcohol can significantly impact the severity and course of psoriasis, with Mediterranean and protein-restricted diets showing potential benefits.

While dietary and lifestyle changes are important, they should complement conventional treatments rather than replace them, highlighting the need for healthcare providers to guide patients on effective lifestyle modifications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The role of lifestyle and nutrition in psoriasis: Current status of knowledge and interventions. Musumeci, ML., Nasca, MR., Boscaglia, S., et al.[2022]

In a study of 211 patients with Psoriatic Arthritis (PsA), moderate adherence to the Mediterranean diet was observed in 66.35% of participants, indicating a potential dietary influence on disease management.

Higher disease activity in PsA, as measured by the Disease Activity Index for Psoriatic Arthritis (DAPSA), was negatively associated with adherence to the Mediterranean diet, suggesting that this diet may have anti-inflammatory benefits for patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mediterranean diet and Psoriatic Arthritis activity: a multicenter cross-sectional study. Caso, F., Navarini, L., Carubbi, F., et al.[2021]

The Mediterranean Diet (MedDiet) has been linked to a reduced risk of chronic inflammatory diseases such as metabolic syndrome, atherosclerosis, and diabetes, suggesting its protective health benefits.

Recent studies indicate that the MedDiet promotes the secretion of anti-inflammatory cytokines and improves antioxidant biomarkers, highlighting its role in preventing cardiovascular and other chronic degenerative diseases through a holistic dietary approach.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Health benefits of the Mediterranean Diet: an update of research over the last 5 years. Gotsis, E., Anagnostis, P., Mariolis, A., et al.[2022]

The Mediterranean diet (MeDi) is associated with improved health outcomes and may help reduce the risk of non-communicable diseases (NCDs), as summarized from 33 articles including systematic reviews and meta-analyses.

Combining the MeDi with physical activity and avoiding tobacco and excessive alcohol consumption enhances its health benefits, suggesting a comprehensive approach to promoting better health.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mediterranean diet and health outcomes: a systematic meta-review. Martinez-Lacoba, R., Pardo-Garcia, I., Amo-Saus, E., et al.[2019]

Psoriatic patients consumed significantly less anti-inflammatory foods like olive oil, fish, and nuts compared to healthy controls, while they consumed more pro-inflammatory foods such as dairy and soft drinks, suggesting dietary choices may influence psoriasis severity.

The study found that lower severity of psoriasis was associated with higher vegetable intake, whereas higher consumption of red meat and instant noodles correlated with greater severity, highlighting the potential impact of diet on managing psoriasis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dietary habits and perceptions of psoriatic patients: Mediterranean versus Asian diets. Ingkapairoj, K., Chularojanamontri, L., Chaiyabutr, C., et al.[2022]

The Mediterranean diet (MedDiet) significantly reduced total plasma cholesterol and LDL cholesterol levels in men with metabolic syndrome, even without weight loss, indicating its efficacy in improving certain cardiovascular risk factors.

When combined with a 10.2% weight loss, the MedDiet led to substantial improvements in multiple cardiometabolic risk factors, including lower blood pressure, triglycerides, and insulin levels, highlighting the importance of weight loss in maximizing the diet's benefits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of the Mediterranean diet with and without weight loss on cardiovascular risk factors in men with the metabolic syndrome. Richard, C., Couture, P., Desroches, S., et al.[2017]

In a study of 60 adults with non-alcoholic fatty liver disease (NAFLD), those who adhered more closely to the Mediterranean diet showed significant reductions in intrahepatic fat content, liver damage markers, and improvements in cardiorespiratory fitness after a 6-month intervention.

Higher adherence to the Mediterranean diet was associated with increased antioxidant enzyme activity and decreased levels of inflammation biomarkers, indicating that this dietary approach may effectively reduce oxidative stress and inflammation in NAFLD patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Increased Adherence to the Mediterranean Diet after Lifestyle Intervention Improves Oxidative and Inflammatory Status in Patients with Non-Alcoholic Fatty Liver Disease. Monserrat-Mesquida, M., Quetglas-Llabrés, M., Bouzas, C., et al.[2022]

The Diet and Psoriasis Project (DIEPP) is investigating the relationship between dietary factors and psoriasis severity, focusing on the Mediterranean diet and time-restricted eating as potential therapeutic strategies.

This research aims to provide insights into how diet may influence psoriasis and contribute to developing medically approved dietary recommendations, addressing the link between psoriasis and associated conditions like type 2 diabetes and cardiovascular disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Approaches to nutrition intervention in plaque psoriasis, a multi-system inflammatory disease-The Diet and Psoriasis Project (DIEPP). Zanesco, S., Hall, W., Gibson, R., et al.[2023]

This study investigates the relationship between adherence to the Mediterranean diet and the severity of moderate to severe psoriasis, which is linked to chronic inflammation and cardiovascular risk.

The authors aim to establish a cut-off point for dietary adherence that could help differentiate patients needing systemic or biological treatments, highlighting the potential role of diet in managing psoriasis severity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adherence to Mediterranean diet in Spanish patients with psoriasis: Cardiovascular benefits? Molina-Leyva, A., Cuenca-Barrales, C., Vega-Castillo, JJ., et al.[2019]

A study involving 35,735 participants from the NutriNet-Santé program found that higher adherence to the Mediterranean diet (measured by the MEDI-LITE score) is associated with a lower risk of severe psoriasis, suggesting a protective effect against the disease.

The results indicate that patients with severe psoriasis tend to have lower adherence to the Mediterranean diet, supporting the idea that dietary changes could be beneficial in managing psoriasis severity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Association Between Mediterranean Anti-inflammatory Dietary Profile and Severity of Psoriasis: Results From the NutriNet-Santé Cohort. Phan, C., Touvier, M., Kesse-Guyot, E., et al.[2019]

In a study of 13,284 participants, the dietary inflammatory index (DII) was not found to be associated with the occurrence of psoriasis, suggesting that diet-induced inflammation may not play a significant role in developing this skin condition.

Despite the potential health risks of a pro-inflammatory diet, the analysis indicated that individuals with higher DII scores did not have a higher risk of psoriasis compared to those with lower scores, highlighting the complexity of dietary impacts on skin health.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dietary inflammatory potential and psoriasis: A cross-sectional study. Liu, N., Zhang, C., Hua, W.[2023]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40991259/

Mediterranean Diet and Patients With Psoriasis Conclusions and relevance: This randomized clinical trial found that a 16-week Mediterranean diet intervention significantly improved psoriasis ...

2. jamanetwork.com jamanetwork.com/journals/jamadermatology/article-abstract/2839013

Mediterranean Diet and Patients With Psoriasis Conclusions and Relevance This randomized clinical trial found that a 16-week Mediterranean diet intervention significantly improved psoriasis ...

3. ajmc.com ajmc.com/view/mediterranean-diet-improves-psoriasis-severity-study-finds

Mediterranean Diet Improves Psoriasis Severity, Study Finds A 16-week Mediterranean diet reduced psoriasis severity and improved metabolic health in patients with mild to moderate psoriasis.

4. healio.com healio.com/news/dermatology/20251003/intensive-mediterranean-diet-may-yield-significant-improvement-in-psoriasis-symptoms

Mediterranean diet could improve psoriasis symptoms Patients in a 16-week Mediterranean diet program saw improvements in their psoriasis compared with those on a standard low-fat diet.

5. gastroenterologyadvisor.com gastroenterologyadvisor.com/news/mediterranean-diet-linked-to-improvement-in-psoriasis/

Mediterranean Diet Linked to Improvement in Psoriasis In the Mediterranean diet group, 47.4 percent achieved a 75 percent reduction in PASI compared with 0 percent in the control group. There was ...

6. sciencedirect.com sciencedirect.com/science/article/pii/S0261561425001426

Are psoriasis severity and comorbidities associated with ... Participants with psoriasis showed slightly better adherence to a Mediterranean-style diet but also consumed more processed meat, sodium, free sugars, and ...