The DIET Trial - Dietetic Intervention in Psoriatic Arthritis

Metabolic Syndrome Clinical Trial

— DIET  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03142503
• Other study ID #: 2012/18701-2
• Status: Completed
• Phase: N/A
• First received: April 6, 2017
• Last updated: May 4, 2017
• Start date: January 21, 2013
• Est. completion date: June 22, 2015

Study information

• Verified date: May 2017
• Source: Federal University of São Paulo
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 194
• Est. completion date: June 22, 2015
• Est. primary completion date: March 16, 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Psoriatic
• Metabolic Syndrome
• Metabolic Syndrome X

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Federal University of São Paulo

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Disease activity	To evaluate the increase of Minimal Disease Activity (MDA) after intervention	12 weeks
Secondary	Fat Mass	To analyze the decrease of Fat Mass Index (kg/m^2)	12 weeks
Secondary	Lean Mass	To evaluate the increase of Muscle Mass (kg)	12 weeks
Secondary	Waist circumference	To observe the improvement of waist circumference (cm)	12 weeks
Secondary	Body Mass Index	To analyze the improvement of Body Mass Index (kg/m^2)	12 weeks
Secondary	Glycation markers	To analyze the decrease of receptor for advanced glycation end products receptor (RAGE)	12 weeks
Secondary	Anti-inflammatory marker	To analyze the increase of adiponectin	12 weeks
Secondary	Lipidic Peroxidation	To analyze the improvement of malondialdehyde (TBARs)	12 weeks
Secondary	Inflammatory markers	To observe the improvement of LDL fractions	12 weeks
Secondary	Cutaneous activity	To evaluated the reduction in cutaneous activity, evaluated by PASI (Psoriasis Area Severity Index)	12 weeks
Secondary	Articular activity	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).	12 weeks