Diet Interventions in Psoriatic Arthritis

Study Purpose

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

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	18 Years - 80 Years
Gender	All

More Inclusion & Exclusion 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

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT04180904
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	N/A
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	University of Pennsylvania
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Alexis Ogdie-Beatty, MD, MSCELihi Eder, MD, PhD
Principal Investigator Affiliation	University of PennsylvaniaWomen's College Hospital, University of Toronto
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Recruiting
Countries	Canada, United States
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Psoriatic Arthritis

Additional Details

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.

Arms & Interventions

Arms

Active Comparator: Diet 1

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

Active Comparator: Diet 2

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

No Intervention: Diet 3

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

Interventions

Other: - Diet 1

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

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).

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

University of Pennsylvania, Philadelphia, Pennsylvania

Status

Recruiting

Address

University of Pennsylvania

Philadelphia, Pennsylvania, 19104

Site Contact

Sarah Gillespie, MS

[email protected]

215-614-1840

International Sites

Toronto, Ontario, Canada

Status

Recruiting

Address

Women's College Hospital, University of Toronto

Toronto, Ontario,

Site Contact

Shani Nagler, M.Sc.

[email protected]

416-323-6400 #5109

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