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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03142503
Other study ID # 2012/18701-2
Secondary ID
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
Health authority
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

Study Design


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
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