Diet Interventions in Psoriatic Arthritis

University of Pennsylvania92 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Psoriatic Arthritis

Interventions

Diet 1OTHER

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

Diet 2OTHER

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).

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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

Locations (2)

University of Pennsylvania

Philadelphia, Pennsylvania, United States

Women's College Hospital, University of Toronto

Toronto, Ontario, Canada

Outcomes

Primary Outcomes

Change in Disease Activity in Psoriatic Arthritis (DAPSA)

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 1. Tender Joints Count (0-68 joints) 2. Swollen Joints Count (0-66 joints) 3. CRP (mg/dl) 4. Patient's assessment of disease activity and pain: 1. How active was your rheumatic disease on average during the last week? Scale of 1-10 (Not Active -Active) 2. How would you describe the overall level of joint pain during the last week? Scale of 1-10 (None-Very Severe)

Time frame: 12 weeks

Secondary Outcomes

Change in Disease Activity in Psoriatic Arthritis (DAPSA)

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 1. Tender Joints Count (0-68 joints) 2. Swollen Joints Count (0-66 joints) 3. CRP (mg/dl) 4. Patient's assessment of disease activity and pain: 1. How active was your rheumatic disease on average during the last week? Scale of 1-10 (Not Active -Active) 2. How would you describe the overall level of joint pain during the last week? Scale of 1-10 (None-Very Severe)

Time frame: 24 weeks

Patient Reported Outcomes-Psoriatic Arthritis Disease Impact

-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.

Data from ClinicalTrials.gov

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