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Completed

NCT Number: NCT03142503

The DIET Trial - Dietetic Intervention in Psoriatic Arthritis

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.

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Key information

Conditions

Arthritis, Psoriatic Arthritis Bone Diseases Glucose Metabolism Disorders Hyperinsulinism Insulin Resistance Joint Diseases Metabolic Diseases Metabolic Syndrome Musculoskeletal Diseases Nutritional and Metabolic Diseases Psoriasis Skin Diseases Skin Diseases, Papulosquamous Skin and Connective Tissue Diseases Spinal Diseases Spondylarthritis Spondylarthropathies Spondylitis

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Diet + supplementation

Dietary Supplement

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

Dietary Supplement

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

Dietary Supplement

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

Primary outcomes

  1. Disease activity

    Time frame: 12 weeks

    To evaluate the increase of Minimal Disease Activity (MDA) after intervention

Secondary outcomes

  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).

Sponsors and collaborators

Lead sponsor

Federal University of São Paulo

Other

Registry information

Official study 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

Acronym: DIET

Important dates

Study start
2013
Primary completion
2015
Study completion
2015
First posted
May 5, 2017
Registry last updated
May 5, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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