The DIET Trial - Dietetic Intervention in Psoriatic Arthritis (DIET)

May 4, 2017 updated by: Marcelo M Pinheiro, Federal University of São Paulo

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

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

194

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Soybean supplementation
Dietary supplement: Placebo
Supplementation of 1g soybean oil, 3 times a day.
Active Comparator: Diet + placebo
Soybean supplementation and diet intervention
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.
Experimental: Diet + Supplementation
Omega 3 and diet 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Disease activity
Time Frame: 12 weeks
To evaluate the increase of Minimal Disease Activity (MDA) after intervention
12 weeks

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Federal University of São Paulo

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 21, 2013

Primary Completion (Actual)

March 16, 2015

Study Completion (Actual)

June 22, 2015

Study Registration Dates

First Submitted

April 6, 2017

First Submitted That Met QC Criteria

May 4, 2017

First Posted (Actual)

May 5, 2017

Study Record Updates

Last Update Posted (Actual)

May 5, 2017

Last Update Submitted That Met QC Criteria

May 4, 2017

Last Verified

May 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2012/18701-2

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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