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

Trial Summary

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.

What data supports the effectiveness of the Mediterranean Diet as a treatment for psoriasis?

Research suggests that the Mediterranean Diet, which is rich in fiber, vitamins, and anti-inflammatory foods, may help reduce the severity of psoriasis by lowering inflammation and improving overall health. It is also associated with benefits for metabolic health, which is often linked to psoriasis. ^{1 2 3 4 5}

Is the Mediterranean diet safe for humans?

The Mediterranean diet is generally considered safe for humans and has been shown to reduce chronic inflammation and improve cardiovascular health, which are beneficial for overall well-being. ^{1 3 6 7 8}

How does the Mediterranean Diet treatment for psoriasis differ from other treatments?

The Mediterranean Diet is unique for psoriasis treatment because it focuses on reducing inflammation through a holistic dietary approach, rather than using medication. This diet emphasizes whole foods like fruits, vegetables, and healthy fats, which may help lower disease activity by reducing chronic inflammation. ^{9 10 11 12 13}

What is the purpose of this trial?

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.

Research Team

Neil Korman

Principal Investigator

University Hospitals Cleveland Medical Center

Jordan Kahle, MD

Principal Investigator

University Hospitals Cleveland Medical Center

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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 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]

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]

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 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]

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]

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) 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]

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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Association Between Mediterranean Anti-inflammatory Dietary Profile and Severity of Psoriasis: Results From the NutriNet-Santé Cohort. [2019]

2. England pubmed.ncbi.nlm.nih.gov

Nutrition and psoriasis: is there any association between the severity of the disease and adherence to the Mediterranean diet? [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Adherence to Mediterranean diet in Spanish patients with psoriasis: Cardiovascular benefits? [2019]

4. Switzerland pubmed.ncbi.nlm.nih.gov

Metabolic Disorders and Psoriasis: Exploring the Role of Nutritional Interventions. [2023]

5. United States pubmed.ncbi.nlm.nih.gov

The role of lifestyle and nutrition in psoriasis: Current status of knowledge and interventions. [2022]

6. England pubmed.ncbi.nlm.nih.gov

Dietary habits and perceptions of psoriatic patients: Mediterranean versus Asian diets. [2022]

7. England pubmed.ncbi.nlm.nih.gov

Approaches to nutrition intervention in plaque psoriasis, a multi-system inflammatory disease-The Diet and Psoriasis Project (DIEPP). [2023]

8. England pubmed.ncbi.nlm.nih.gov

Dietary inflammatory potential and psoriasis: A cross-sectional study. [2023]

9. Germany pubmed.ncbi.nlm.nih.gov

Mediterranean diet and Psoriatic Arthritis activity: a multicenter cross-sectional study. [2021]

10. Netherlands 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. [2017]

11. United States pubmed.ncbi.nlm.nih.gov

Health benefits of the Mediterranean Diet: an update of research over the last 5 years. [2022]

12. England pubmed.ncbi.nlm.nih.gov

Mediterranean diet and health outcomes: a systematic meta-review. [2019]

13. Switzerland 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. [2022]