Anxiety, Depression, Hyperlipidemias, Metabolic Syndrome, Obesity, Psoriasis, Psoriasis Vulgaris
Conditions
Keywords
Psoriasis, Mediterranean diet, Dietary intervention, Psoriasis vulgaris, Metabolic syndrome
Brief summary
The goal of this clinical trial is to determine the effect of a high-intensity Mediterranean diet intervention over 16 weeks in a group of patients with mild to moderate psoriasis in terms of skin improvement as measured by PASI. In addition, the aim of this study will be to gather the necessary information for a larger and more extended clinical trial in the future. Participants will be provided with dietary education for the implementation of the Mediterranean diet, supported by a monthly follow-up by nutritionists with experience in the field. Researchers will compare the effect of the Mediterranean diet on these patients to a control group provided with standard recommendations for a low-fat diet with no monitoring by nutritionists.
Detailed description
MEDIPSO is an experimental, randomised, controlled, open-label, single-blinded (evaluator) study. It is a clinical trial in which patients with mild to moderate psoriasis with stable topical treatment are randomly assigned to either the control group or the intervention group. Patients assigned to the intervention group will undergo dietary education for the adoption of the Mediterranean diet, with monthly monitoring - mostly online - by nutritionists with experience in the field. In both groups, blood tests with metabolic parameters will be obtained before and after the study period, and data of anthropometric characteristics and quality of life will be assessed. The effect of the intervention on skin involvement, metabolic parameters and inflammatory cytokines will be assessed, and the emotional and quality of life impact will also be investigated. In addition, a methodological analysis will be carried out in order to improve the design for a larger scale clinical trial in the future.
Interventions
OTHERHigh-intensity Mediterranean diet intervention
Dietary education for the adoption of the Mediterranean diet, with monthly monitoring - mostly online - by nutritionists with experience in the field. Patients will be given 500 ml of extra virgin olive oil per week and informative material about the Mediterranean diet, as well as recipes and weekly menus.
Sponsors
Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Intervention model description
Experimental, randomised, controlled, open-label, single-blind (outcome assessor) study.
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* Psoriasis clinically diagnosed by a dermatologist. * Predominantly psoriasis vulgaris. * Psoriasis Area and Severity Index (PASI) ≥2 and ≤ 10 at the time of recruitment. * Stable weight (\< 5% weight loss or gain) in the last 3 months. * Treated exclusively with topical treatment for psoriasis at enrolment and throughout the study. * Able to give informed consent. * Willing and able to follow the study procedure. * Willing and able to attend all scheduled visits during the study period. * Willing and able to provide blood samples as indicated in the procedure. * Willing to implement pregnancy prevention measures throughout the study period.
Exclusion criteria
* Type 1 or 2 diabetes mellitus. * Good adherence to the Mediterranean diet at the time of screening (er-MEDAS ≥8). * Language barrier (patients not fluent in Spanish or English). * Conditions that make telephone communication difficult (e.g. severe hearing loss). * History of cardiac disease(s). * Comorbidities that may compromise the implementation of the intervention (e.g. cancer, digestive diseases...) or limit survival to less than 6 months. * History or current eating disorder (anorexia, bulimia, etc.; screening will be carried out using the Diagnostic and Statistical Manual of Mental Disorders, fifth edition, if indicated). * Malnourished patients (screening using the Malnutrition Universal Screening Tool -MUST-, if indicated). * Presenting gout. * Pregnant, planning pregnancy or breastfeeding. * Use of diuretics at the time of sampling. * BMI greater than 40 kg/m2. * Difficulty or inconvenience in changing dietary habits and following the Mediterranean diet (allergies, food intolerances, special diets). * Participation in a clinical trial with drugs or dietary intervention in the year prior to inclusion in this study. * Patients who during the recruitment period are expected to have poor collaboration, lack of commitment or real difficulties in following the development of the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline in the Psoriasis Area and Severity Index (PASI) at week 16 | Baseline and week 16 | The Psoriasis Area Severity Index (PASI) is the most widely used scale for assessing the severity of psoriasis and for therapeutic decision making. It ranges from 0 (no lesions) to 72 (worst possible lesions throughout all body surface). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline in body mass index (BMI) at week 16 | Baseline and week 16 | BMI in kg/m\^2 will be assessed by a physician at baseline and week 16 |
| Change from baseline in abdominal circumference at week 16 | Baseline and week 16 | Abdominal circumference in centimetres will be assessed by a physician at baseline and week 16 |
| Change from baseline in serum inflammatory interleukins at week 16 | Baseline and week 16 | Change in levels of Granulocyte-macrophage colony-stimulating factor (GM-CSF), interferon gamma (IFNγ), interleukin 1β (IL-1β), IL 2, IL 4, IL 5, IL 6, IL 9, IL 10, IL 12 (p70), IL 13, IL 15, IL 17A/CTLA8, IL-17E/ IL-25, IL 17F, IL 21, IL 22, IL 23, IL 27, IL 28A/IFNλ2, IL 31, IL 33/NF HEV (mature), MIP-3α/CCL20, tumoral necrosis factor alpha (TNFα) and TNFβ/Lymphotoxin-α (LTA), all of them measured in pg/ml will also be assessed. |
| Change from baseline in serum lipids at week 16 | Baseline and week 16 | Change in levels of serum cholesterol, low-density lipoproteins (LDL), high-density lipoproteins (HDL), lipoprotein A, apolipoprotein A1, apolipoprotein B1 measured in mg/dl will also be assessed. |
| Change from baseline in fasting serum insulin levels at week 16 | Baseline and week 16 | Change in levels of fasting serum insulin levels measured in µUl/ml will also be assessed. |
| Change from baseline in weight at week 16 | Baseline and week 16 | Weight in kilograms will be assessed by a physician at baseline and week 16 |
| Change from baseline in C reactive protein at week 16 | Baseline and week 16 | Change in levels of C reactive protein measured in mg/L will also be assessed. |
| Change from baseline in adherence to mediterranean diet at week 16 | Baseline and week 16 | Change in adherence to mediterranean diet will be assessed by the validated questionnaire energy-restricted Mediterranean Diet Adherence Screener (er-MEDAS), which ranges from 0 to 17 (higher score means better adherence to Mediterranean diet) |
| Change from baseline in quality of life at week 16 | Baseline and week 16 | Change in quality of life will be assessed by the validated questionnaire Dermatology Life Quality Index (DLQI), which ranges from 0 to 30 (higher score means worse quality of life) |
| Change from baseline in quality of sleep at week 16 | Baseline and week 16 | Change in quality of sleep will be assessed by the validated questionnaire Insomnia Severity Index (ISI), which ranges from 0 to 28 (higher score means more severe insomnia) |
| Change from baseline in emotional state at week 16 | Baseline and week 16 | Change in emotional state will be assessed by the validated questionnaire Hospital Anxiety and Depression Scale (HADS). It consists of two sub-scales for Anxiety and Depression, both of which range from 0 to 21 (higher score means more severe anxiety/depression symptoms) |
| Change from baseline in glycated haemoglobin at week 16 | Baseline and week 16 | Change in levels of glycated haemoglobin measured in percentage (%) will also be assessed. |
Countries
Spain
Outcome results
None listed