The DIET Trial - Dietetic Intervention in Psoriatic Arthritis

Federal University of São Paulo194 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

DOUBLE

Enrollment

194

Conditions

Arthritis, Psoriatic Metabolic Syndrome

Interventions

Diet + supplementationDIETARY_SUPPLEMENT

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.

Diet + placeboDIETARY_SUPPLEMENT

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.

PlaceboDIETARY_SUPPLEMENT

Supplementation of 1g soybean oil, 3 times a day.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Disease activity

To evaluate the increase of Minimal Disease Activity (MDA) after intervention

Time frame: 12 weeks

Secondary Outcomes

Fat Mass

To analyze the decrease of Fat Mass Index (kg/m\^2)

Time frame: 12 weeks

Lean Mass

To evaluate the increase of Muscle Mass (kg)

Time frame: 12 weeks

Waist circumference

To observe the improvement of waist circumference (cm)

Time frame: 12 weeks

Body Mass Index

To analyze the improvement of Body Mass Index (kg/m\^2)

Time frame: 12 weeks

Glycation markers

To analyze the decrease of receptor for advanced glycation end products receptor (RAGE)

Time frame: 12 weeks

Anti-inflammatory marker

To analyze the increase of adiponectin

Time frame: 12 weeks

Lipidic Peroxidation

To analyze the improvement of malondialdehyde (TBARs)

Time frame: 12 weeks

Inflammatory markers

To observe the improvement of LDL fractions

Time frame: 12 weeks

Data from ClinicalTrials.gov

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