The DIET Trial - Dietetic Intervention in Psoriatic Arthritis

Federal University of São Paulo

Status: Completed

Conditions: Arthritis, Psoriatic; Metabolic Syndrome

Treatments: Dietary Supplement: Diet + supplementation; Dietary Supplement: Placebo; Dietary Supplement: Diet + placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT03142503

2012/18701-2

Details and patient eligibility

About

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.

Enrollment: 194 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Double Blind

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194 participants in 3 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

Soybean supplementation

Treatment:

Dietary Supplement: Placebo

Diet + placebo

Active Comparator group

Description:

Soybean supplementation and diet intervention

Treatment:

Dietary Supplement: Diet + placebo

Diet + Supplementation

Experimental group

Description:

Omega 3 and diet intervention

Treatment:

Dietary Supplement: Diet + supplementation