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

Primary Purpose

Arthritis, Psoriatic, Metabolic Syndrome

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Diet + supplementation
Diet + placebo
Placebo
Sponsored by
Federal University of São Paulo
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Arthritis, Psoriatic focused on measuring psoriatic arthritis, psoriasis, body composition, DXA measurements, spondyloarthritis, diet therapy, adipose tissue

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Placebo Comparator

    Active Comparator

    Experimental

    Arm Label

    Placebo

    Diet + placebo

    Diet + Supplementation

    Arm Description

    Soybean supplementation

    Soybean supplementation and diet intervention

    Omega 3 and diet intervention

    Outcomes

    Primary Outcome Measures

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

    Secondary Outcome Measures

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

    Full Information

    First Posted
    April 6, 2017
    Last Updated
    May 4, 2017
    Sponsor
    Federal University of São Paulo
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03142503
    Brief Title
    The DIET Trial - Dietetic Intervention in Psoriatic Arthritis
    Acronym
    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
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2017
    Overall Recruitment Status
    Completed
    Study Start Date
    January 21, 2013 (Actual)
    Primary Completion Date
    March 16, 2015 (Actual)
    Study Completion Date
    June 22, 2015 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Federal University of São Paulo

    4. Oversight

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Arthritis, Psoriatic, Metabolic Syndrome
    Keywords
    psoriatic arthritis, psoriasis, body composition, DXA measurements, spondyloarthritis, diet therapy, adipose tissue

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Factorial Assignment
    Masking
    ParticipantInvestigator
    Allocation
    Randomized
    Enrollment
    194 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Placebo
    Arm Type
    Placebo Comparator
    Arm Description
    Soybean supplementation
    Arm Title
    Diet + placebo
    Arm Type
    Active Comparator
    Arm Description
    Soybean supplementation and diet intervention
    Arm Title
    Diet + Supplementation
    Arm Type
    Experimental
    Arm Description
    Omega 3 and diet intervention
    Intervention Type
    Dietary Supplement
    Intervention Name(s)
    Diet + supplementation
    Intervention Description
    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.
    Intervention Type
    Dietary Supplement
    Intervention Name(s)
    Diet + placebo
    Intervention Description
    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.
    Intervention Type
    Dietary Supplement
    Intervention Name(s)
    Placebo
    Intervention Description
    Supplementation of 1g soybean oil, 3 times a day.
    Primary Outcome Measure Information:
    Title
    Disease activity
    Description
    To evaluate the increase of Minimal Disease Activity (MDA) after intervention
    Time Frame
    12 weeks
    Secondary Outcome Measure Information:
    Title
    Fat Mass
    Description
    To analyze the decrease of Fat Mass Index (kg/m^2)
    Time Frame
    12 weeks
    Title
    Lean Mass
    Description
    To evaluate the increase of Muscle Mass (kg)
    Time Frame
    12 weeks
    Title
    Waist circumference
    Description
    To observe the improvement of waist circumference (cm)
    Time Frame
    12 weeks
    Title
    Body Mass Index
    Description
    To analyze the improvement of Body Mass Index (kg/m^2)
    Time Frame
    12 weeks
    Title
    Glycation markers
    Description
    To analyze the decrease of receptor for advanced glycation end products receptor (RAGE)
    Time Frame
    12 weeks
    Title
    Anti-inflammatory marker
    Description
    To analyze the increase of adiponectin
    Time Frame
    12 weeks
    Title
    Lipidic Peroxidation
    Description
    To analyze the improvement of malondialdehyde (TBARs)
    Time Frame
    12 weeks
    Title
    Inflammatory markers
    Description
    To observe the improvement of LDL fractions
    Time Frame
    12 weeks
    Title
    Cutaneous activity
    Description
    To evaluated the reduction in cutaneous activity, evaluated by PASI (Psoriasis Area Severity Index)
    Time Frame
    12 weeks
    Title
    Articular activity
    Description
    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).
    Time Frame
    12 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    80 Years
    Accepts Healthy Volunteers
    No
    Eligibility 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

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    35387686
    Citation
    Leite BF, Morimoto MA, Gomes CMF, Klemz BNC, Genaro PS, Shivappa N, Hebert JR, Damasceno NRT, Pinheiro MM. Dietetic intervention in psoriatic arthritis: the DIETA trial. Adv Rheumatol. 2022 Apr 6;62(1):12. doi: 10.1186/s42358-022-00243-6.
    Results Reference
    derived

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    The DIET Trial - Dietetic Intervention in Psoriatic Arthritis

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