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Completed

NCT Number: NCT04180904

Diet Interventions in Psoriatic Arthritis

The purpose of this study is to learn whether changing diet impacts psoriatic arthritis (PsA).

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Key information

Conditions

Psoriatic Arthritis Arthritis Arthritis, Psoriatic Bone Diseases Joint Diseases Musculoskeletal Diseases Psoriasis Salivary Gland Adenoma, Pleomorphic 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

Primary location

Women's College Hospital, University of Toronto, Toronto, Ontario, Canada

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About this study

The study asks if dietary change and nutritional support improves disease activity and if patients are better able to improve or sustain progress with additional incentives. The study will use an online program to communicate with participants through text and online surveys. This 24-week trial will enroll 90 patients in the US and Canada with New York University as a back-up site.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Age 18-80
  • Required Rheumatologist-confirmed diagnosis of PsA fulfilling Classification of Psoriatic Arthritis Criteria (CASPAR)
  • Willing to alter diet and participate for 24 weeks
  • Able to attend follow-up visits
  • Body mass index (BMI) > 25 and <40
  • No history of eating disorders such as anorexia or bulimia
  • Disease Activity in Psoriatic Arthritis Assessment (DAPSA) > 10
  • Stable treatment for PsA for ≥3 months prior to enrollment (patients may be on any disease modifying anti-rheumatic drugs (DMARDs) or they can be free of systemic medications
  • Owns and uses an iPhone or Android smart phone, or is willing to use a device provided by the study team

Exclusion criteria

  • Inability to provide informed consent
  • Plan to change systemic treatment for psoriasis or PsA in the next 4-8 weeks
  • Use of systemic corticosteroids
  • All persons who would be placed at an increased risk including any medical condition that will impair the ability of the person to participate in a nutritional intervention study (e.g. insulin dependent diabetes, use of coumadin, advanced malignancy, inflammatory bowel disease, dementia)
  • History of food allergy to any of the components of olive oil or nuts
  • Inability to read and write in English
  • Unwillingness to change dietary habits
  • Known pregnancy (pregnancy testing will be performed for women of childbearing age; weight changes will not accurately reflect the changes we would anticipate in pregnant patients and weight loss may be detrimental to maternal and/or fetal outcomes).
  • Participation in another physical activity study and/or diet trial

Treatment and study plan

Diet 1

Other

Diet 1 will focus on which foods are eaten and the impact on disease outcomes.

Diet 2

Other

This diet will limit the amount of food energy consumed each day and the impact on disease outcomes. This will be determined by factors including the subject's demographics (age, sex, weight, height).

Primary outcomes

  1. Change in Disease Activity in Psoriatic Arthritis (DAPSA)

    Time frame: 12 weeks

    Disease Activity in Psoriatic Arthritis (DAPSA) is a total of the 5 elements listed below to assess disease activity from both clinical and patient-reported data. The total score falls within a range to indicate level of disease activity: 0-4 = Remission (minimum); 5-14 = Low; 15-28 = Moderate; >28 = High Disease Activity. There is no theoretical upper limit to the DAPSA score.

    Total DAPSA score = TJ (Tender Joints) + SJ (Swollen Joints) + CRP (C-reactive protein) + Activity + Pain

    • Tender Joints Count (0-68 joints)
    • Swollen Joints Count (0-66 joints)
    • CRP (mg/dl)
    • Patient's assessment of disease activity and pain:
    • How active was your rheumatic disease on average during the last week? Scale of 1-10 (Not Active -Active)
    • How would you describe the overall level of joint pain during the last week? Scale of 1-10 (None-Very Severe)

Secondary outcomes

  1. Change in Disease Activity in Psoriatic Arthritis (DAPSA)

    Time frame: 24 weeks

    Disease Activity in Psoriatic Arthritis (DAPSA) is a total of the 5 elements listed below to assess disease activity from both clinical and patient-reported data. The total score falls within a range to indicate level of disease activity: 0-4 = Remission (minimum); 5-14 = Low; 15-28 = Moderate; >28 = High Disease Activity. There is no theoretical upper limit to the DAPSA score.

    DAPSA = TJ (Tender Joints) + SJ (Swollen Joints) + CRP (C-reactive protein) + Activity + Pain

    • Tender Joints Count (0-68 joints)
    • Swollen Joints Count (0-66 joints)
    • CRP (mg/dl)
    • Patient's assessment of disease activity and pain:
    • How active was your rheumatic disease on average during the last week? Scale of 1-10 (Not Active -Active)
    • How would you describe the overall level of joint pain during the last week? Scale of 1-10 (None-Very Severe)

  2. Patient Reported Outcomes-Psoriatic Arthritis Disease Impact

    Time frame: Varying times: (at Baseline) 0, 12, 24 Weeks

    -Psoriatic Arthritis Disease Impact- Psoriatic Arthritis Impact of Disease (PSAID). The PsAID is a measure developed by the European League Against Rheumatism (EULAR) and is composed of domains selected by an international group of patients with psoriatic arthritis. The questionnaire uses a weighted scoring system (weights were derived by patient impression of importance) and has a range of 0-10. A lower score indicates lower impact of disease from the patient perspective, and a score of 4 is considered a patient acceptable symptom state.

  3. Patient Reported Outcomes-Fatigue

    Time frame: Varying times: (at Baseline) 0, 12, 24 Weeks

    -Fatigue- PROMIS (Patient-Reported Outcomes Measurement Information System) Fatigue (CAT) The PROMIS Fatigue scale assesses fatigue experience and impact of fatigue over 7 days. The instrument includes items on exhaustion and ability to function normally in physical, social, mental and family roles and activities. This instrument has good content validity and responsiveness in rheumatoid arthritis, a similar inflammatory arthritis. We will use the CAT (Computerized Adaptive Test) response instrument. PROMIS uses Item Response Theory (IRT) statistical model that links individual questions to a presumed underlying trait or concept of global health represented by all items in the scale; instruments are scored using item-level calibrations ("response pattern scoring") in an online tool (T-Score range 0-100, where 50 is the mean with a standard deviation of 10). Increasing score indicates higher level of fatigue.

  4. Metabolic Profile-Weight

    Time frame: Varying times: (at Baseline) 0, 12, 24 Weeks

    Changes in Weight; Weight_kg; Weight and Height will be combined to report BMI in kg/m^2; Body Mass Index (BMI) _ wt/h²; The standard weight status categories associated with BMI ranges for adults are listed as;

    BMI Weight Status:

    Below 18.5 Underweight 18.5 - 24.9 Normal or Healthy Weight 25.0 - 29.9 Overweight 30.0 and Above Obese

    Accessed on 11/19/19, https://www.cdc.gov/healthyweight/assessing/bmi/adult_bmi/index.html#Interpreted

  5. Metabolic Profile-Waist Measurement

    Time frame: Varying times: (at Baseline) 0, 12, 24 Weeks

    Waist measurement_cm

Sponsors and collaborators

Lead sponsor

University of Pennsylvania

Other

Collaborators

  • NYU Langone Health
  • Women's College Hospital

Registry information

Acronym: DIPSA

Important dates

Study start
2021
Primary completion
2024
Study completion
2024
First posted
Nov 29, 2019
Registry last updated
Jun 29, 2026

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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