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

Federal University of São Paulo0 sites194 target enrollmentJanuary 21, 2013

ConditionsArthritis, Psoriatic Metabolic Syndrome

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Arthritis, Psoriatic
Sponsor: Federal University of São Paulo
Enrollment: 194
Primary Endpoint: Disease activity
Status: Completed
Last Updated: 8 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

January 21, 2013

End Date

June 22, 2015

Last Updated

8 years ago

Study Type

Interventional

Study Design

Factorial

Sex

All

Investigators

Sponsor

Federal University of São Paulo

Responsible Party

Principal Investigator

Marcelo M Pinheiro

Assistant Professor

Federal University of São Paulo

Eligibility Criteria

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