Mediterranean Diet for Psoriasis
Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
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
Trial Summary
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.
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.
12345Is 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.
13678How 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.
910111213Eligibility 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.
+2 more
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
+17 more
Trial 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
Participant Groups
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.
2Treatment groups
Active Control
Group I: No Dietary InterventionActive Control1 Intervention
Participants in this arm will have no dietary intervention.
Group II: Mediterranean DietActive Control1 Intervention
Participants in this arm will follow the Mediterranean Diet.
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
University Hospitals Cleveland Medical CenterCleveland, OH
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Who Is Running the Clinical Trial?
Neil KormanLead Sponsor
References
Association Between Mediterranean Anti-inflammatory Dietary Profile and Severity of Psoriasis: Results From the NutriNet-Santé Cohort. [2019]Psoriasis is a chronic inflammatory disease. The Mediterranean diet has been shown to reduce chronic inflammation and has a positive effect on the risk of metabolic syndrome and cardiovascular events. Thus, we hypothesized a positive effect on the onset and/or severity of psoriasis.
Nutrition and psoriasis: is there any association between the severity of the disease and adherence to the Mediterranean diet? [2022]Many studies have evaluated the role of individual nutrients on the development of psoriasis. However, only few studies have investigated the effect of a healthy eating pattern, such as the Mediterranean diet. In this study, we aimed to investigate the relationship between adherence to the Mediterranean diet, the body composition and the severity of psoriasis in a group of naïve-treatment patients with psoriasis.
Adherence to Mediterranean diet in Spanish patients with psoriasis: Cardiovascular benefits? [2019]Several studies have evaluated the role of individual nutrients on psoriasis. Only a few of them have evaluated the benefits of healthy dietary patterns and the effect of the Mediterranean diet on psoriasis with promising results. Moderate-severe psoriasis is associated with chronic systemic inflammation and increased cardiovascular risk. In this study the present authors measure the adherence to the Mediterranean diet to determine the grade of association with severity of psoriasis, a cardiovascular profile, and systemic inflammation. Our aim was to determine a cut-off point that approximates the real clinical practice by differentiating patients with systemic or biological treatment.
Metabolic Disorders and Psoriasis: Exploring the Role of Nutritional Interventions. [2023](1) Background: Psoriasis is a chronic autoimmune disease with a close relationship with metabolic diseases such as obesity, diabetes, and dyslipidemia. The aim of this review was to identify the relationship between psoriasis, metabolic diseases, and dietetic therapies. According to recent findings, there is a strong association between psoriasis and obesity as well as vitamin D and micronutrient deficiencies. (2) Methods: This review was conducted via PubMed, aiming to search for studies involving psoriasis linked with metabolic disorders or with nutritional treatments. (3) Results: Our review shows that a healthy lifestyle can positively influence the course of the disease. The maintaining of a proper body weight together with physical activity and good nutritional choices are associated with an improvement in psoriasis severity. A Mediterranean diet rich in fiber, vitamins, and polyphenols may indeed be a strategy for controlling psoriasis symptoms. The effectiveness of this diet lies not only in its anti-inflammatory power, but also in its ability to favorably influence the intestinal microbiota and counteract dysbiosis, which is a risk factor for many autoimmune diseases. (4) Conclusions: In synergy with standard therapy, the adoption of an appropriate diet can be recommended to improve the clinical expression of psoriasis and reduce the incidence of comorbidities.
The role of lifestyle and nutrition in psoriasis: Current status of knowledge and interventions. [2022]Extrinsic environmental factors, including patient lifestyle (alcohol intake, smoking, stress, sleep disturbances, and sedentary habit), diet and single nutrients intake may affect psoriasis clinical presentation, severity, and course. All English language articles dealing with psoriasis and lifestyle factors or diet gathered by an extensive PubMed search were carefully examined in order to explore their impact on the disease. Current authoritative knowledge confirms that low-calories, Mediterranean, and protein restricted/vegetarian diets may be beneficial. Psoriatic patients are also recommended to engage regular physical activity, to avoid alcohol intake and to consume fish rich in omega-3 polyunsaturated fatty acids, as well as fruit and vegetables. Prebiotics and probiotics may also provide potential benefit, whereas vitamin D supplementation and gluten-free diet are useful in selected cases only. Changing of dietary and lifestyle habits alone does not replace conventional treatment, but must be considered as an adjuvant. Physicians may play a crucial role, by adequately acknowledging psoriatic patients on the advantages of proper lifestyle and diet habits as well as providing clues to reliable sources of dietary advice.
Dietary habits and perceptions of psoriatic patients: Mediterranean versus Asian diets. [2022]Mediterranean diets have been reported to improve psoriasis. Asian food has a unique character and differs from Mediterranean diets.
Approaches to nutrition intervention in plaque psoriasis, a multi-system inflammatory disease-The Diet and Psoriasis Project (DIEPP). [2023]Psoriasis is an immune-mediated inflammatory skin disease affecting approximately 2% of the UK population. Its pathogenesis is suggested to be an outcome of genetic and environmental interplay. People with psoriasis have an increased likelihood of developing other conditions such as type 2 diabetes and cardiovascular disease. Systemic inflammation is hypothesised to be the common link between psoriasis and cardio-metabolic diseases. Emerging evidence shows diet as a potential therapeutic adjunct in the management of psoriasis. The Diet and Psoriasis Project (DIEPP) aims to investigate whether dietary factors are related to psoriasis severity by conducting an observational study followed by a dietary intervention trial, to assess the effect of the Mediterranean diet (MedD) and time-restricted eating (TRE) on psoriasis. This review article will explore the potential mechanisms by which the MedD and TRE may exert protective effects on psoriasis, evaluate the current evidence, and outline the design of the DIEPP. Given the early-stage evidence, we hope to be able to build knowledge to derive medically approved dietary recommendations and contribute to the research gaps exploring the role of diet and psoriasis.
Dietary inflammatory potential and psoriasis: A cross-sectional study. [2023]Diet is an important source of inflammation, and diet-induced inflammation might be associated with the etiopathogenesis of psoriasis. This study aimed to explore the relationship between dietary inflammatory index (DII), a literature-derived dietary tool to measure individual dietary inflammatory potential, and incident psoriasis. This was a cross-sectional study based on the 2003-2006 and 2009-2014 National Health and Nutrition Examination Surveys. The calculation of DII was based on 24-h dietary recall. Psoriasis was defined by a self-reported medical questionnaire. Logistic regressions were introduced to calculate the odds ratio (OR) and 95% confidence interval (CI) of psoriasis relative to DII. Restricted cubic splines (RCS) were used to test the nonlinear relationship in the regression model. A total of 13 284 participants with an average age of 48.94 ± 17.71 years were enrolled. The prevalence rate psoriasis was 2.88% (95% CI 2.61, 3.18). Incident psoriasis was not associated with DII in a multivariable logistic regression model (OR = 1.00, 95% CI 0.89, 1.11). Compared to participants in the lowest DII tertile, OR for those in the highest was 0.81 (95% CI 0.51, 1.28, P for trend = 0.0974). Subgroup analysis indicated that DII was still not associated with psoriasis in participants with different population settings. RCS showed that DII was not associated with psoriasis in either an overall or a nonlinear manner. Although a proinflammatory diet could lead to several health risks, psoriasis occurrence might not be associated with dietary inflammatory potential in this cross-sectional study.
Mediterranean diet and Psoriatic Arthritis activity: a multicenter cross-sectional study. [2021]Diet is a modifiable factor implicated in chronic systemic inflammation, and the mediterranean dietary pattern is considered to be a healthy model in terms of morbidity and mortality. The main aim of this study was to evaluate the adherence to the mediterranean diet in patients with Psoriatic Arthritis (PsA) and its impact on disease activity. A cross-sectional observational study was conducted in a cohort of 211 consecutive PsA patients. We evaluated PsA activity by disease activity index for PSoriatic Arthritis (DAPSA) and composite psoriatic disease activity index (CPDAI). The NCEP-ACT III criteria were used to identify subjects with MetS, and in each subject, we evaluated body mass index (BMI). A validated 14-item questionnaire for the assessment of adherence to the mediterranean diet (PREDIMED) was recorded for all the enrolled subjects. Patients showed a median age of 55 (48-62) and disease duration was 76 (36-120) months. 27.01% of patients were classified as having MetS. The median of the mediterranean diet score (MDS) was 7 (6-9). A moderate adherence to mediterranean diet was found in 66.35% of the entire cohort; 15.64% and 18.01% of the patients showed low- and high adherence to the dietary pattern, respectively. We found a negative association between DAPSA and adherence to mediterranean diet (B = - 3.291; 95% CI - 5.884 to - 0.698). DAPSA was positively associated with BMI (B = 0.332; 95% CI 0.047-0.618) and HAQ ( B = 2.176; 95% CI 0.984-3.368). Results from our study evidenced that in PsA patients, higher levels of disease activity as measured by DAPSA correlated with low adherence to mediterranean diet, suggesting potential benefit of antinflammatory properties of this dietary pattern.
Effect of the Mediterranean diet with and without weight loss on cardiovascular risk factors in men with the metabolic syndrome. [2017]No study has yet examined how weight loss modifies the impact of the Mediterranean diet (MedDiet) on cardiovascular risk factors in men with the metabolic syndrome (MetS). The objective of the study was to assess the efficacy of MedDiet, with and without weight loss, to modify the cardiometabolic risk profile of male patients with MetS.
Health benefits of the Mediterranean Diet: an update of research over the last 5 years. [2022]The Mediterranean Diet (MedDiet) has been reported to be protective against the occurrence of several diseases. Increasing evidence suggests that the MedDiet could counter diseases associated with chronic inflammation, including metabolic syndrome, atherosclerosis, cancer, diabetes, obesity, pulmonary diseases, and cognition disorders. Adoption of a MedDiet was associated with beneficial effects on the secretion of anti-inflammatory cytokines, antioxidant cellular and circulating biomarkers as well as with regulation of gene polymorphisms involved in the atherosclerotic process. The MedDiet has been considered for the prevention of cardiovascular and other chronic degenerative diseases focusing on the impact of a holistic dietary approach rather than on single nutrients. Epidemiological dietary scores measuring adherence to a MedDiet have been developed. This narrative review considers the results of up-to-date clinical studies (with a focus on the last 5 years) that evaluated the effectiveness of the MedDiet in reducing the prevalence of chronic and degenerative diseases.
Mediterranean diet and health outcomes: a systematic meta-review. [2019]The Mediterranean diet (MeDi) is considered a healthy dietary pattern, and greater adherence to this diet may improve health status. It also may reduce the social and economic costs of diet-related illnesses. This meta-review aims to summarize, synthesize and organize the effects of MeDi pattern on different health outcomes.
Increased Adherence to the Mediterranean Diet after Lifestyle Intervention Improves Oxidative and Inflammatory Status in Patients with Non-Alcoholic Fatty Liver Disease. [2022]A Mediterranean diet (MedDiet) is recommended as a therapy for non-alcoholic fatty liver disease (NAFLD) because there is no specific pharmacological treatment for this disease.