Study Results
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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COMPLETED
NA
90 participants
INTERVENTIONAL
2021-03-11
2024-11-25
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
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.
Diet 1
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.
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).
Diet 3
Diet 3 will focus on healthy dietary patterns and provide nutritional support with a dietitian.
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.
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).
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
80 Years
ALL
No
Sponsors
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Women's College Hospital
OTHER
NYU Langone Health
OTHER
University of Pennsylvania
OTHER
Responsible Party
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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
Women's College Hospital, University of Toronto
Toronto, Ontario, Canada
Countries
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Other Identifiers
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834176
Identifier Type: -
Identifier Source: org_study_id
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