Psoriatic ArthritisDIPSANCT04180904
Diet Interventions in Psoriatic Arthritis
A study testing Diet 1 and Diet 2 in people with Psoriatic Arthritis, run by University of Pennsylvania at 2 sites in 2 countries.
Trial summary
The purpose of this study is to learn whether changing diet impacts psoriatic arthritis (PsA). Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Psoriatic Arthritis
- What is being tested?
- Diet 1 and Diet 2
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 92 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 11 Mar 2021to 25 Nov 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 9Show fewer
- 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
Who cannot join
- 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
Show all 9Show fewer
- 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 locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
United States1 site
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
About this study
The purpose of this study is to learn whether changing diet impacts psoriatic arthritis (PsA).
Read the detailed 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.
- Conditions
- Psoriatic Arthritis
- Being tested
- Diet 1, Diet 2
- Keywords
- PsA (Psoriatic Arthritis), Diet, Food, Nutrition
- Medical subject headings
- Arthritis, Psoriatic, Salivary Gland Adenoma, Pleomorphic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diet 1Other
Diet 1 will focus on which foods are eaten and the impact on disease outcomes.
Diet 2Other
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).
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Diet 2 |
| Diet 3 | No intervention | Diet 3 will focus on healthy dietary patterns and provide nutritional support with a dietitian. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Disease Activity in Psoriatic Arthritis (DAPSA)
Disease Activity in Psoriatic Arthritis (DAPSA) is a total of the 5 elements listed below to assess disease activity from both clinical and patient-reported data. The total score falls within a range to indicate level of disease activity: 0-4 = Remission (minimum); 5-14 = Low; 15-28 = Moderate; >28 = High Disease Activity. There is no theoretical upper limit to the DAPSA score.
Total DAPSA score = TJ (Tender Joints) + SJ (Swollen Joints) + CRP (C-reactive protein) + Activity + Pain
- Tender Joints Count (0-68 joints)
- Swollen Joints Count (0-66 joints)
- CRP (mg/dl)
- 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)
Measured: 12 weeks
Secondary outcomes (5)
Change in Disease Activity in Psoriatic Arthritis (DAPSA)
Disease Activity in Psoriatic Arthritis (DAPSA) is a total of the 5 elements listed below to assess disease activity from both clinical and patient-reported data. The total score falls within a range to indicate level of disease activity: 0-4 = Remission (minimum); 5-14 = Low; 15-28 = Moderate; >28 = High Disease Activity. There is no theoretical upper limit to the DAPSA score.
DAPSA = TJ (Tender Joints) + SJ (Swollen Joints) + CRP (C-reactive protein) + Activity + Pain
- Tender Joints Count (0-68 joints)
- Swollen Joints Count (0-66 joints)
- CRP (mg/dl)
- 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)
Measured: 24 weeks
Patient Reported Outcomes-Psoriatic Arthritis Disease Impact
-Psoriatic Arthritis Disease Impact- Psoriatic Arthritis Impact of Disease (PSAID). The PsAID is a measure developed by the European League Against Rheumatism (EULAR) and is composed of domains selected by an international group of patients with psoriatic arthritis. The questionnaire uses a weighted scoring system (weights were derived by patient impression of importance) and has a range of 0-10. A lower score indicates lower impact of disease from the patient perspective, and a score of 4 is considered a patient acceptable symptom state.
Measured: Varying times: (at Baseline) 0, 12, 24 Weeks
Patient Reported Outcomes-Fatigue
-Fatigue- PROMIS (Patient-Reported Outcomes Measurement Information System) Fatigue (CAT) The PROMIS Fatigue scale assesses fatigue experience and impact of fatigue over 7 days. The instrument includes items on exhaustion and ability to function normally in physical, social, mental and family roles and activities. This instrument has good content validity and responsiveness in rheumatoid arthritis, a similar inflammatory arthritis. We will use the CAT (Computerized Adaptive Test) response instrument. PROMIS uses Item Response Theory (IRT) statistical model that links individual questions to a presumed underlying trait or concept of global health represented by all items in the scale; instruments are scored using item-level calibrations ("response pattern scoring") in an online tool (T-Score range 0-100, where 50 is the mean with a standard deviation of 10). Increasing score indicates higher level of fatigue.
Measured: Varying times: (at Baseline) 0, 12, 24 Weeks
Metabolic Profile-Weight
Changes in Weight; Weight_kg; Weight and Height will be combined to report BMI in kg/m^2; Body Mass Index (BMI) _ wt/h²; The standard weight status categories associated with BMI ranges for adults are listed as;
BMI Weight Status:
Below 18.5 Underweight 18.5 - 24.9 Normal or Healthy Weight 25.0 - 29.9 Overweight 30.0 and Above Obese
Accessed on 11/19/19, https://www.cdc.gov/healthyweight/assessing/bmi/adult_bmi/index.html#Interpreted
Measured: Varying times: (at Baseline) 0, 12, 24 Weeks
Metabolic Profile-Waist Measurement
Waist measurement_cm
Measured: Varying times: (at Baseline) 0, 12, 24 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2019
- Study start11 Mar 2021
- Primary completion25 Nov 2024
- Study completion25 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Psoriatic ArthritisStudies of the same condition, open and under way.
- More trials run by University of PennsylvaniaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 92 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Collaborators
- Women's College Hospital, NYU Langone Health
- Responsible party
- Sponsor
- Investigators
- Alexis Ogdie-Beatty, MD, MSCE, Principal investigator, University of PennsylvaniaLihi Eder, MD, PhD, Principal investigator, Women's College Hospital, University of Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04180904
- Sponsor's protocol ID
- 834176
- Acronym
- DIPSA
- Status last verified
- Jun 2026
- First submitted
- 14 Nov 2019
- Last updated
- 29 Jun 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Manuscripts describing research results will be drafted and submitted in a timely manner for publication in widely circulated peer-reviewed journals. Physicians and researchers may request de-identified data from the PI and research plans will be reviewed on a case by case basis.
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diet Interventions in Psoriatic Arthritis
- ClinicalTrials.gov ID
- NCT04180904
- Acronym / sponsor ID
- DIPSA / 834176
- Conditions
- Psoriatic Arthritis
- Keywords
- PsA (Psoriatic Arthritis), Diet, Food, Nutrition
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 92 participants (actual)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Collaborators
- Women's College Hospital, NYU Langone Health
- Study start
- 11 Mar 2021 (actual)
- Primary completion
- 25 Nov 2024 (actual)
- Study completion
- 25 Nov 2024 (actual)
- First posted
- 29 Nov 2019 (actual)
- Results
- Posted 29 Jun 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to learn whether changing diet impacts psoriatic arthritis (PsA).
Detailed 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Diet 1 | Active comparator | Other: Diet 1Diet 1 will focus on the dietary pattern and monitor types of foods, supplementary nutrition, and provide nutritional support with a dietitian. |
| Diet 2 | Active comparator | Other: Diet 2Diet 2 will focus on the dietary pattern and monitor the amount of food, complimentary nutrition, and nutritional support with a dietitian. |
| Diet 3 | No intervention | –Diet 3 will focus on healthy dietary patterns and provide nutritional support with a dietitian. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Diet 1Diet 1 will focus on which foods are eaten and the impact on disease outcomes. | Other | Diet 1 |
| Diet 2This 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). | Other | Diet 2 |
Primary outcome
Change in Disease Activity in Psoriatic Arthritis (DAPSA)
Time frame: 12 weeks
Disease Activity in Psoriatic Arthritis (DAPSA) is a total of the 5 elements listed below to assess disease activity from both clinical and patient-reported data. The total score falls within a range to indicate level of disease activity: 0-4 = Remission (minimum); 5-14 = Low; 15-28 = Moderate; >28 = High Disease Activity. There is no theoretical upper limit to the DAPSA score. Total DAPSA score = TJ (Tender Joints) + SJ (Swollen Joints) + CRP (C-reactive protein) + Activity + Pain 1. Tender Joints Count (0-68 joints) 2. Swollen Joints Count (0-66 joints) 3. CRP (mg/dl) 4. Patient's assessment of disease activity and pain: 1. How active was your rheumatic disease on average during the last week? Scale of 1-10 (Not Active -Active) 2. How would you describe the overall level of joint pain during the last week? Scale of 1-10 (None-Very Severe)
5 secondary outcomes
Change in Disease Activity in Psoriatic Arthritis (DAPSA)
Time frame: 24 weeks
Patient Reported Outcomes-Psoriatic Arthritis Disease Impact
Time frame: Varying times: (at Baseline) 0, 12, 24 Weeks
Patient Reported Outcomes-Fatigue
Time frame: Varying times: (at Baseline) 0, 12, 24 Weeks
Metabolic Profile-Weight
Time frame: Varying times: (at Baseline) 0, 12, 24 Weeks
Metabolic Profile-Waist Measurement
Time frame: Varying times: (at Baseline) 0, 12, 24 Weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No. Manuscripts describing research results will be drafted and submitted in a timely manner for publication in widely circulated peer-reviewed journals. Physicians and researchers may request de-identified data from the PI and research plans will be reviewed on a case by case basis.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alexis Ogdie-Beatty, MD, MSCE principal investigator
University of Pennsylvania
Lihi Eder, MD, PhD principal investigator
Women's College Hospital, University of Toronto
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Diet 1 and Diet 2 in people with Psoriatic Arthritis, run by University of Pennsylvania at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 29 Jun 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Disease Activity in Psoriatic Arthritis (DAPSA) (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jun 2026.