The DIET Trial - Dietetic Intervention in Psoriatic Arthritis

Not Applicable

Completed

• Conditions: Arthritis, Psoriatic; Metabolic Syndrome
• Interventions: Dietary Supplement: Placebo; Dietary Supplement: Diet + placebo; Dietary Supplement: Diet + supplementation

• Registration Number: NCT03142503
• Lead Sponsor: Federal University of São Paulo

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-01-21
• Primary Completion: 2015-03-16
• Study Completion: 2015-06-22
• Study First Submitted: 2017-04-06
• Status Verified: 2017-05
• Study First Submitted QC: 2017-05-04
• Last Update Submitted: 2017-05-04
• Study First Posted: 2017-05-05
• Last Update Posted: 2017-05-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 194

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Soybean supplementation
Diet + placebo	Diet + placebo	Soybean supplementation and diet intervention
Diet + Supplementation	Diet + supplementation	Omega 3 and diet intervention

Primary Outcome Measures

Name	Time	Method
Disease activity	12 weeks	To evaluate the increase of Minimal Disease Activity (MDA) after intervention

Secondary Outcome Measures

Name	Time	Method
Glycation markers	12 weeks	To analyze the decrease of receptor for advanced glycation end products receptor (RAGE)
Lean Mass	12 weeks	To evaluate the increase of Muscle Mass (kg)
Waist circumference	12 weeks	To observe the improvement of waist circumference (cm)
Lipidic Peroxidation	12 weeks	To analyze the improvement of malondialdehyde (TBARs)
Body Mass Index	12 weeks	To analyze the improvement of Body Mass Index (kg/m\^2)
Inflammatory markers	12 weeks	To observe the improvement of LDL fractions
Fat Mass	12 weeks	To analyze the decrease of Fat Mass Index (kg/m\^2)
Anti-inflammatory marker	12 weeks	To analyze the increase of adiponectin
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).