Metabolic Syndrome Clinical Trial
— DIETOfficial title:
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
Verified date | May 2017 |
Source | Federal University of São Paulo |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 194 |
Est. completion date | June 22, 2015 |
Est. primary completion date | March 16, 2015 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 80 Years |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Federal University of São Paulo |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Disease activity | To evaluate the increase of Minimal Disease Activity (MDA) after intervention | 12 weeks | |
Secondary | Fat Mass | To analyze the decrease of Fat Mass Index (kg/m^2) | 12 weeks | |
Secondary | Lean Mass | To evaluate the increase of Muscle Mass (kg) | 12 weeks | |
Secondary | Waist circumference | To observe the improvement of waist circumference (cm) | 12 weeks | |
Secondary | Body Mass Index | To analyze the improvement of Body Mass Index (kg/m^2) | 12 weeks | |
Secondary | Glycation markers | To analyze the decrease of receptor for advanced glycation end products receptor (RAGE) | 12 weeks | |
Secondary | Anti-inflammatory marker | To analyze the increase of adiponectin | 12 weeks | |
Secondary | Lipidic Peroxidation | To analyze the improvement of malondialdehyde (TBARs) | 12 weeks | |
Secondary | Inflammatory markers | To observe the improvement of LDL fractions | 12 weeks | |
Secondary | Cutaneous activity | To evaluated the reduction in cutaneous activity, evaluated by PASI (Psoriasis Area Severity Index) | 12 weeks | |
Secondary | 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 |
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