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Diet Interventions in Psoriatic Arthritis (DIPSA)

Primary Purpose

Psoriatic Arthritis

Status

Recruiting

Phase

Not Applicable

Locations

International

Study Type

Interventional

Intervention

Diet 1

Diet 2

About this trial

This is an interventional treatment trial for Psoriatic Arthritis focused on measuring PsA (Psoriatic Arthritis), Diet, Food, Nutrition

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

University of PennsylvaniaRecruiting
Women's College Hospital, University of TorontoRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

No Intervention

Arm Label

Diet 1

Diet 2

Diet 3

Arm Description

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

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

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

Outcomes

Primary Outcome Measures

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 Tender Joints Count (0-68), TJ: Swollen Joints Count (0-66), SJ: 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)

Secondary Outcome Measures

Change in Psoriasis Area and Severity Index (PASI)

A measurement of the severity of psoriasis; 0 (no disease) to 72 (maximal disease)

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 + SJ + CRP + Activity + Pain Tender Joints Count (0-68), TJ: Swollen Joints Count (0-66), SJ: 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)

Patient Reported Outcomes-Physical Function

-Physical Function-International Physical Activity Questionnaire (IPAQ) We will examine change in physical activity over the study (as we will be advising patients not to change exercise habits). IPAQ is an instrument for assessing levels and patterns of physical activity. IPAQ has been validated in healthy adults and is publicly available, open access, and no permissions are required for use.

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 with 4 being considered a patient acceptable symptom state. The proposed Minimal Clinically Important Difference (MCID) is 3.

Patient Reported Outcomes-Skin Disease Impact

-Skin Disease Impact- Psoriasis Area and Severity Index (PASI). The Psoriasis Area Severity Index (PASI) is an index used to express the severity of psoriasis. It combines the severity (erythema (redness), induration (thickness) and desquamation (peeling) and percentage of affected area. This is the primary outcome measure in trials of psoriatic arthritis.

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.

Patient Reported Outcomes-Depression

-Depression- PROMIS (Patient-Reported Outcomes Measurement Information System) Depression (CAT) The PROMIS Depression assesses sadness, guilt, self-criticism, worthlessness, loneliness, loss of interest, meaning, and purpose. The PROMIS depression scale is used across diseases but has been specifically demonstrated to have good responsiveness with therapy in patients with rheumatoid arthritis. The item bank assesses symptoms over the past 7 days. (Suicidality is not assessed in this questionnaire). We will use the CAT (Computerized Adaptive Test) response instrument.

Metabolic Profile-Blood Pressure

Change in Blood Pressure Blood Pressure; BP _ systolic/diastolic; Both pressures will be assessed during the study period.

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

Metabolic Profile-Height

Height_M; Height and Weight will be combined to report BMI in kg/m^2

Metabolic Profile-Waist Measurement

Waist measurement_cm

Metabolic Profile- Blood Glucose Studies

Blood Glucose Studies-HbA1C; HbA1c___________ % Normal: HbA1c below 5.7% Prediabetes: HbA1c between 5.7% and 6.4 Diabetes: HbA1c of 6.5% or higher; Accessed on 11/19/19, https://medlineplus.gov/lab-tests/hemoglobin-a1c-hba1c-test/

Metabolic Profile- C-reactive protein

C-reactive protein: General index used for inflammation

Therapy changes

Any changes in medications therapies will be recorded (in particular psoriatic arthritis medications, NSAIDs, cholesterol medications, high blood pressure medications, and Type 2 diabetes medications).

Preliminary Safety: Adverse event (AE)/ Serious Adverse Event (SAE)

AEs and SAEs are reported separately. Participants can report an adverse event at any time but will be asked about it at 12 weeks and analyzed at 24 weeks.

Full Information

NCT ID

NCT04180904

First Posted

November 14, 2019

Last Updated

January 17, 2023

Sponsor

University of Pennsylvania

Collaborators

Women's College Hospital, NYU Langone Health

1. Study Identification

Unique Protocol Identification Number

NCT04180904

Brief Title

Diet Interventions in Psoriatic Arthritis

Acronym

DIPSA

Official Title

Diet Interventions in Psoriatic Arthritis

Study Type

Interventional

2. Study Status

Record Verification Date

January 2023

Overall Recruitment Status

Recruiting

Study Start Date

March 11, 2021 (Actual)

Primary Completion Date

November 2024 (Anticipated)

Study Completion Date

November 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University of Pennsylvania

Collaborators

Women's College Hospital, NYU Langone Health

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Psoriatic Arthritis

Keywords

PsA (Psoriatic Arthritis), Diet, Food, Nutrition

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

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

Outcomes Assessor

Masking Description

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.

Allocation

Randomized

Enrollment

90 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Diet 1

Arm Type

Active Comparator

Arm Description

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

Arm Title

Diet 2

Arm Type

Active Comparator

Arm Description

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

Arm Title

Diet 3

Arm Type

No Intervention

Arm Description

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

Intervention Type

Other

Intervention Name(s)

Diet 1

Intervention Description

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

Intervention Type

Other

Intervention Name(s)

Diet 2

Intervention Description

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).

Primary Outcome Measure Information:

Title

Change in Disease Activity in Psoriatic Arthritis (DAPSA)

Description

Time Frame

12 weeks

Secondary Outcome Measure Information:

Title

Change in Psoriasis Area and Severity Index (PASI)

Description

A measurement of the severity of psoriasis; 0 (no disease) to 72 (maximal disease)

Time Frame

24 weeks

Title

Change in Disease Activity in Psoriatic Arthritis (DAPSA)

Description

Time Frame

24 weeks

Title

Patient Reported Outcomes-Physical Function

Description

Time Frame

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

Title

Patient Reported Outcomes-Psoriatic Arthritis Disease Impact

Description

Time Frame

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

Title

Patient Reported Outcomes-Skin Disease Impact

Description

Time Frame

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

Title

Patient Reported Outcomes-Fatigue

Description

Time Frame

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

Title

Patient Reported Outcomes-Depression

Description

Time Frame

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

Title

Metabolic Profile-Blood Pressure

Description

Change in Blood Pressure Blood Pressure; BP _ systolic/diastolic; Both pressures will be assessed during the study period.

Time Frame

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

Title

Metabolic Profile-Weight

Description

Time Frame

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

Title

Metabolic Profile-Height

Description

Height_M; Height and Weight will be combined to report BMI in kg/m^2

Time Frame

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

Title

Metabolic Profile-Waist Measurement

Description

Waist measurement_cm

Time Frame

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

Title

Metabolic Profile- Blood Glucose Studies

Description

Time Frame

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

Title

Metabolic Profile- C-reactive protein

Description

C-reactive protein: General index used for inflammation

Time Frame

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

Title

Therapy changes

Description

Time Frame

Chart review at 12 and 24 Weeks

Title

Preliminary Safety: Adverse event (AE)/ Serious Adverse Event (SAE)

Description

AEs and SAEs are reported separately. Participants can report an adverse event at any time but will be asked about it at 12 weeks and analyzed at 24 weeks.

Time Frame

12 Weeks, 24 Weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility 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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Kathleen Bush

Phone

215-662-6332

katbu@pennmedicine.upenn.edu

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Alexis Ogdie-Beatty, MD, MSCE

Organizational Affiliation

University of Pennsylvania

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Lihi Eder, MD, PhD

Organizational Affiliation

Women's College Hospital, University of Toronto

Official's Role

Principal Investigator

Facility Information:

Facility Name

University of Pennsylvania

City

Philadelphia

State/Province

Pennsylvania

ZIP/Postal Code

19104

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Michele Almonte, BSN

Phone

215-349-5261

michele.almonte@pennmedicine@upenn.edu

First Name & Middle Initial & Last Name & Degree

Kathleen Bush, BS

katbu@pennmedicine.upenn.edu

First Name & Middle Initial & Last Name & Degree

Alexis Ogdie-Beatty, MD, MSCE

Facility Name

Women's College Hospital, University of Toronto

City

Toronto

State/Province

Ontario

Country

Canada

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Shani Nagler, M.Sc.

Phone

416-323-6400

Ext

5109

Shani.Nagler@wchospital.ca

First Name & Middle Initial & Last Name & Degree

Lihi Eder, MD, PhD

12. IPD Sharing Statement

Plan to Share IPD

IPD Sharing Plan Description

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.

Learn more about this trial

Diet Interventions in Psoriatic Arthritis

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