Diet Interventions in Psoriatic Arthritis

NCT04180904 | Completed

• 1 other identifier: 834176
• Study Type: interventional
• Target: 90
• Locations: 2 countries
• Sites: 2

Brief Summary

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

Conditions

Psoriatic Arthritis

Keywords

PsA (Psoriatic Arthritis), Diet, Food, Nutrition

Outcome Measures

Primary Outcomes (1)

• Change in Disease Activity in Psoriatic Arthritis (DAPSA)

  Disease Activity(DAPSA): 0-4 Remission; 5-14 Low; 15-28 Moderate; \> (Greater than) 28 High Disease Activity, DAPSA = TJ (Tender Joints) + SJ (Swollen Joints) + CRP (C-reactive protein) + Activity + Pain 1. Tender Joints Count (0-68), TJ: 2. Swollen Joints Count (0-66), SJ: 3. CRP (mg/dl): 4. 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)

  12 weeks

Secondary Outcomes (15)

• Change in Psoriasis Area and Severity Index (PASI)

  24 weeks

• Change in Disease Activity in Psoriatic Arthritis (DAPSA)

  24 weeks

• Patient Reported Outcomes-Physical Function

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

• Patient Reported Outcomes-Psoriatic Arthritis Disease Impact

  Varying times: (at Baseline) 0, 4, 8, 12, 16, 20, 24 Weeks

• Patient Reported Outcomes-Skin Disease Impact

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

Study Arms (3)

Diet 1

ACTIVE COMPARATOR

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

Other: Diet 1

Diet 2

ACTIVE COMPARATOR

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

Other: Diet 2

Diet 3

NO INTERVENTION

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

Interventions

Diet 1 OTHER

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

Diet 1

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).

Diet 2

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Pennsylvania: lead
• Women's College Hospital: collaborator
• NYU Langone Health: collaborator

Study Sites (2)

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Women's College Hospital, University of Toronto

Toronto, Ontario, Canada

Location

MeSH Terms

Conditions

Arthritis, Psoriatic; Salivary Gland Adenoma, Pleomorphic

Condition Hierarchy (Ancestors)

Spondylarthropathies; Spondylarthritis; Spondylitis; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Arthritis; Joint Diseases; Psoriasis; Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Alexis Ogdie-Beatty, MD, MSCE

  University of Pennsylvania

  PRINCIPAL INVESTIGATOR

• Lihi Eder, MD, PhD

  Women's College Hospital, University of Toronto

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: In a study assessing dietary behavioral interventions, absolute blinding of the participants is not possible because of obvious differences between intervention diets. However, we will avoid naming the allocated dietary intervention and withhold information about our research hypothesis from the patients. Participants in the control group will receive the same schedule of visits and patient reported outcomes. The study rheumatologists (outcome assessors) will be blinded to the allocated group and the participants will be asked to avoid discussing the details of their diet with them.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: November 14, 2019
• First Posted: November 29, 2019
• Study Start: March 11, 2021
• Primary Completion: November 25, 2024
• Study Completion: November 25, 2024
• Last Updated: January 14, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1); US (1)