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

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ClinicalTrials.gov Identifier: NCT03142503
Recruitment Status : Completed
First Posted : May 5, 2017
Last Update Posted : May 5, 2017
Sponsor:
Information provided by (Responsible Party):
Marcelo M Pinheiro, Federal University of São Paulo

Study Description
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Brief 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.

Condition or disease Intervention/treatment Phase
Arthritis, Psoriatic Metabolic Syndrome Dietary Supplement: Diet + supplementation Dietary Supplement: Diet + placebo Dietary Supplement: Placebo Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 194 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
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
Actual Study Start Date : January 21, 2013
Actual Primary Completion Date : March 16, 2015
Actual Study Completion Date : June 22, 2015

Resource links provided by the National Library of Medicine


Arms and Interventions
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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.


Outcome Measures
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Primary Outcome Measures :
  1. Disease activity [ Time Frame: 12 weeks ]
    To evaluate the increase of Minimal Disease Activity (MDA) after intervention


Secondary Outcome Measures :
  1. Fat Mass [ Time Frame: 12 weeks ]
    To analyze the decrease of Fat Mass Index (kg/m^2)

  2. Lean Mass [ Time Frame: 12 weeks ]
    To evaluate the increase of Muscle Mass (kg)

  3. Waist circumference [ Time Frame: 12 weeks ]
    To observe the improvement of waist circumference (cm)

  4. Body Mass Index [ Time Frame: 12 weeks ]
    To analyze the improvement of Body Mass Index (kg/m^2)

  5. Glycation markers [ Time Frame: 12 weeks ]
    To analyze the decrease of receptor for advanced glycation end products receptor (RAGE)

  6. Anti-inflammatory marker [ Time Frame: 12 weeks ]
    To analyze the increase of adiponectin

  7. Lipidic Peroxidation [ Time Frame: 12 weeks ]
    To analyze the improvement of malondialdehyde (TBARs)

  8. Inflammatory markers [ Time Frame: 12 weeks ]
    To observe the improvement of LDL fractions

  9. Cutaneous activity [ Time Frame: 12 weeks ]
    To evaluated the reduction in cutaneous activity, evaluated by PASI (Psoriasis Area Severity Index)

  10. 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).


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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No Contacts or Locations Provided
More Information
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Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Marcelo M Pinheiro, Assistant Professor, Federal University of São Paulo
ClinicalTrials.gov Identifier: NCT03142503    
Other Study ID Numbers: 2012/18701-2
First Posted: May 5, 2017    Key Record Dates
Last Update Posted: May 5, 2017
Last Verified: May 2017
Keywords provided by Marcelo M Pinheiro, Federal University of São Paulo:
psoriatic arthritis
psoriasis
body composition
DXA measurements
 spondyloarthritis
diet therapy
adipose tissue
Additional relevant MeSH terms:
Layout table for MeSH terms
Arthritis
Arthritis, Psoriatic
Metabolic Syndrome
Joint Diseases
Musculoskeletal Diseases
Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases
 Spondylarthropathies
Spondylarthritis
Spondylitis
Spinal Diseases
Bone Diseases
Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases