NCT03142503

The DIET Trial - Dietetic Intervention in Psoriatic Arthritis

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 194 (actual)
• Sponsor: Federal University of São Paulo · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Arthritis, Psoriatic
• Metabolic Syndrome

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Diet + supplementation	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.
DIETARY_SUPPLEMENT	Diet + placebo	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.
DIETARY_SUPPLEMENT	Placebo	Supplementation of 1g soybean oil, 3 times a day.

Timeline

• Start date: 2013-01-21
• Primary completion: 2015-03-16
• Completion: 2015-06-22
• First posted: 2017-05-05
• Last updated: 2017-05-05