Diet Interventions in Psoriatic Arthritis (DIPSA)

University of Pennsylvania

Status: Completed

Conditions: Psoriatic Arthritis

Treatments: Other: Diet 2; Other: Diet 1

Study type: Interventional

Funder types: Other

Identifiers

NCT04180904

834176

Details and patient eligibility

About

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

Full 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.

Enrollment: 90 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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90 participants in 3 patient groups

Diet 1

Active Comparator group

Description:

Diet 1 will focus on the dietary pattern and monitor types of foods, supplementary nutrition, and provide nutritional support with a dietitian.

Treatment:

Other: Diet 1

Diet 2

Active Comparator group

Description:

Diet 2 will focus on the dietary pattern and monitor the amount of food, complimentary nutrition, and nutritional support with a dietitian.

Treatment:

Other: Diet 2

Diet 3

No Intervention group

Description:

Diet 3 will focus on healthy dietary patterns and provide nutritional support with a dietitian.