Clinical trial NCT04180904: Diet Interventions in Psoriatic Arthritis
Official title: Diet Interventions in Psoriatic Arthritis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Psoriatic Arthritis
Keywords: PsA (Psoriatic Arthritis), Diet, Food, Nutrition
Lead sponsor: University of Pennsylvania
Sponsor class: OTHER
Collaborators: name: Women's College Hospital
name: NYU Langone Health
First posted: 2019-11-29
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: In this randomized controlled pilot trial, we will test different diets to determine the impact on disease outcomes among patients with psoriatic arthritis. This is a 24-week trial that will enroll 90 patients with active psoriatic arthritis despite stable therapy among three sites in the US and Canada. Dietary interventions will be enhanced with gamification, including feedback and competition. Biomarker samples including blood, urine and stool specimens will be collected and banked for exploratory analyses.
Primary purpose: TREATMENT

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

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in Disease Activity in Psoriatic Arthritis (DAPSA)
timeFrame: 12 weeks
Secondary outcomes:
measure: Change in Psoriasis Area and Severity Index (PASI)
timeFrame: 24 weeks
measure: Change in Disease Activity in Psoriatic Arthritis (DAPSA)
timeFrame: 24 weeks
measure: Patient Reported Outcomes-Physical Function
timeFrame: Varying times: (at Baseline) 0,12, 24 Weeks
measure: Patient Reported Outcomes-Psoriatic Arthritis Disease Impact
timeFrame: Varying times: (at Baseline) 0, 4, 8, 12, 16, 20, 24 Weeks
measure: Patient Reported Outcomes-Skin Disease Impact
timeFrame: Varying times: (at Baseline) 0,12, 24 Weeks
measure: Patient Reported Outcomes-Fatigue
timeFrame: Varying times: (at Baseline) 0, 4, 8, 12, 16, 20, 24 Weeks
measure: Patient Reported Outcomes-Depression
timeFrame: Varying times: (at Baseline) 0,12, 24 Weeks
measure: Metabolic Profile-Blood Pressure
timeFrame: Varying times: (at Baseline) 0, 12, 24 Weeks
measure: Metabolic Profile-Weight
timeFrame: Varying times: (at Baseline) 0, 12, 24 Weeks
measure: Metabolic Profile-Height
timeFrame: Varying times: (at Baseline) 0, 12, 24 Weeks
measure: Metabolic Profile-Waist Measurement
timeFrame: Varying times: (at Baseline) 0, 12, 24 Weeks
measure: Metabolic Profile- Blood Glucose Studies
timeFrame: Varying times: (at Baseline) 0, 12, 24 Weeks
measure: Metabolic Profile- C-reactive protein
timeFrame: Varying times: (at Baseline) 0, 12, 24 Weeks
measure: Therapy changes
timeFrame: Chart review at 12 and 24 Weeks
measure: Preliminary Safety: Adverse event (AE)/ Serious Adverse Event (SAE)
timeFrame: 12 Weeks, 24 Weeks
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
city: Toronto
country: Canada
facility: Women's College Hospital, University of Toronto
state: Ontario
Study officials:
affiliation: University of Pennsylvania
name: Alexis Ogdie-Beatty, MD, MSCE
role: PRINCIPAL_INVESTIGATOR
affiliation: Women's College Hospital, University of Toronto
name: Lihi Eder, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: