Diet Interventions in Psoriatic Arthritis

NCT ID: NCT04180904

Last Updated: 2025-01-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-03-11

Study Completion Date

2024-11-25

Brief Summary

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

Detailed Description

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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.

Conditions

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Psoriatic Arthritis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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 Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors
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.

Study Groups

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Diet 1

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

Group Type ACTIVE_COMPARATOR

Diet 1

Intervention Type OTHER

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

Diet 2

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

Group Type ACTIVE_COMPARATOR

Diet 2

Intervention Type 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 3

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Diet 1

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

Intervention Type OTHER

Diet 2

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).

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Women's College Hospital

OTHER

Sponsor Role collaborator

NYU Langone Health

OTHER

Sponsor Role collaborator

University of Pennsylvania

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Alexis Ogdie-Beatty, MD, MSCE

Role: PRINCIPAL_INVESTIGATOR

University of Pennsylvania

Lihi Eder, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Women's College Hospital, University of Toronto

Locations

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University of Pennsylvania

Philadelphia, Pennsylvania, United States

Site Status

Women's College Hospital, University of Toronto

Toronto, Ontario, Canada

Site Status

Countries

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United States Canada

Other Identifiers

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834176

Identifier Type: -

Identifier Source: org_study_id

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