The DIET Trial - Dietetic Intervention in Psoriatic Arthritis

Study Overview
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Brief Summary
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Psoriasis (Ps) and psoriatic arthritis (PsA) are associated with increased risk of metabolic syndrome (MetS), body fatness and cardiovascular risk. Additionally, oxidative stress and inflammation are also contributing mechanisms on Ps and PsA. However, little is known about the influence of diet and micronutrients on the main outcomes of these diseases. The aim of the investigators is to evaluate the effectiveness of an intervention diet program on disease activity, metabolic profile and oxidative stress inpatients with Psoriasis and Psoriatic Arthritis.

Official Title
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Effectiveness of a Dietary Intervention Program on Disease Activity, Metabolism and Oxidative Stress in Patients With Psoriatic Arthritis and Psoriasis Activity: A Clinical, Randomized, Placebo-controlled Trial

Conditions
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Arthritis, Psoriatic, Metabolic Syndrome

Intervention / Treatment
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* Dietary Supplement: Diet + supplementation
* Dietary Supplement: Diet + placebo
* Dietary Supplement: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: patients with psoriatic arthritis, according to the Classification Criteria of Psoriatic Arthritis (CASPAR) Exclusion Criteria: lack of written informed consent; age < 18 years old; history of gastrointestinal, endocrine, pulmonary, kidney, hepatic, and neuromuscular diseases, as well as HIV-positive; pregnant or breast-feeding women; previous history of cancer; use of steroids, protein supplements, vitamins, multivitamins, or antioxidants. Specific medications to PsA and physical activity were required to be stable for the last 3 months to be included in the study

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br>Soybean supplementation | Dietary Supplement: Placebo<br>* Supplementation of 1g soybean oil, 3 times a day.<br>|
| Active Comparator: Diet + placebo<br>Soybean supplementation and diet intervention | Dietary Supplement: Diet + placebo<br>* Supplementation of 1g of soybean oil, 3 times a day, and hypocaloric diet (-500 calories) for 12 weeks, to evaluate weight loss, antioxidant markers and disease activity.<br>|
| Experimental: Diet + Supplementation<br>Omega 3 and diet intervention | Dietary Supplement: Diet + supplementation<br>* Supplementation of 1g of fish oil, 3 time a day, and hypocaloric diet (-500 calories) for 12 weeks, to evaluate weight loss, antioxidant markers and disease activity.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Disease activity | To evaluate the increase of Minimal Disease Activity (MDA) after intervention | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fat Mass | To analyze the decrease of Fat Mass Index (kg/m^2) | 12 weeks | 
| Lean Mass | To evaluate the increase of Muscle Mass (kg) | 12 weeks | 
| Waist circumference | To observe the improvement of waist circumference (cm) | 12 weeks | 
| Body Mass Index | To analyze the improvement of Body Mass Index (kg/m^2) | 12 weeks | 
| Glycation markers | To analyze the decrease of receptor for advanced glycation end products receptor (RAGE) | 12 weeks | 
| Anti-inflammatory marker | To analyze the increase of adiponectin | 12 weeks | 
| Lipidic Peroxidation | To analyze the improvement of malondialdehyde (TBARs) | 12 weeks | 
| Inflammatory markers | To observe the improvement of LDL fractions | 12 weeks | 
| Cutaneous activity | To evaluated the reduction in cutaneous activity, evaluated by PASI (Psoriasis Area Severity Index) | 12 weeks | 
| Articular activity | To evaluate the decrease of articular activity, evaluated by DAS28-CRP (Disease Activity Score-C reactive protein) and DAS28-ESR (Disease Activity Score-Erythrocyte Sedimentation Rate). | 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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psoriatic arthritis, psoriasis, body composition, DXA measurements, spondyloarthritis, diet therapy, adipose tissue