Arthritis, Psoriatic, Metabolic Syndrome
Conditions
Keywords
psoriatic arthritis, psoriasis, body composition, DXA measurements, spondyloarthritis, diet therapy, adipose tissue
Brief summary
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.
Interventions
DIETARY_SUPPLEMENTDiet + supplementation
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.
DIETARY_SUPPLEMENTDiet + placebo
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.
DIETARY_SUPPLEMENTPlacebo
Supplementation of 1g soybean oil, 3 times a day.
Sponsors
Federal University of São Paulo
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Disease activity | 12 weeks | To evaluate the increase of Minimal Disease Activity (MDA) after intervention |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Lean Mass | 12 weeks | To evaluate the increase of Muscle Mass (kg) |
| Waist circumference | 12 weeks | To observe the improvement of waist circumference (cm) |
| Body Mass Index | 12 weeks | To analyze the improvement of Body Mass Index (kg/m\^2) |
| Glycation markers | 12 weeks | To analyze the decrease of receptor for advanced glycation end products receptor (RAGE) |
| Fat Mass | 12 weeks | To analyze the decrease of Fat Mass Index (kg/m\^2) |
| Lipidic Peroxidation | 12 weeks | To analyze the improvement of malondialdehyde (TBARs) |
| Inflammatory markers | 12 weeks | To observe the improvement of LDL fractions |
| Cutaneous activity | 12 weeks | To evaluated the reduction in cutaneous activity, evaluated by PASI (Psoriasis Area Severity Index) |
| Articular activity | 12 weeks | 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). |
| Anti-inflammatory marker | 12 weeks | To analyze the increase of adiponectin |
Outcome results
None listed