Ultrasound Assessment of Rheumatoid Arthritis Patients Who Changed Diet

Study Overview
=================
Brief Summary
-----------------
The purpose of this research study is to evaluate if a weight loss intervention will improve your rheumatoid arthritis disease activity.

Detailed Description
-----------------
This is a pilot 12-week RCT (Randomized Clinical Trial) in 60 obese RA (Rheumatoid Arthritis) patients to evaluate if a weight loss intervention will improve PDUS (Power Doppler Ultra Sound), traditional disease activity measures (DAS28, Disease Activity Score - 28), and adipokine/MBDA (Multi-Biomarker Disease Activity) assessments. While there have been observational weight loss RA studies, none were RCTs and they did not utilize objective measures (PDUS or MBDA).

Official Title
-----------------
Ultrasound Assessment of Rheumatoid Arthritis Patients Who Changed Diet

Conditions
-----------------
Rheumatoid Arthritis, Overweight

Intervention / Treatment
-----------------
* Dietary Supplement: Whey Protein&Prebiotic Supplement
* Behavioral: Dietary Counseling
* Behavioral: Dietary recommendations


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient must meet 1987 ACR (American College of Rheumatology) criteria Age > 18 years of age Baseline DAS28/ESR>3.2 (ESR-erythrocyte sedimentation rate) Stable DMARDs or biologic therapy for at least 12 weeks, or stable off RA therapy 12 weeks. Willingness to participate in a weight loss program BMI > 30 Prednisone ≤ 10 mg Patient has provided informed consent Exclusion Criteria: Major surgery (including joint surgery) within 8 weeks prior to baseline or planned major surgery within 3 months after baseline Evidence of serious uncontrolled concomitant cardiovascular, nervous system, pulmonary, renal, hepatic, endocrine, or gastrointestinal disease Known active current or history of recurrent bacterial, viral, fungal, mycobacterial or other infections (as this may falsely elevate biomarkers) Any major episode of infection requiring hospitalization or treatment with IV antibiotics within 4 weeks of baseline or oral antibiotics within 2 weeks prior to baseline Pregnant women or nursing (breast feeding) mothers Neuropathies or other conditions that might interfere with pain evaluation unless related to primary disease under investigation History of an eating disorder History of bariatric surgery EKG results deeming patient to unsafe for study intervention Allergy to study intervention

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomized Controlled Clinical Trial
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Dietary Supplement<br> | Dietary Supplement: Whey Protein&Prebiotic Supplement<br>* Dietary supplement (protein drink) commercially available protein shakes<br>Behavioral: Dietary recommendations<br>* recommendations for one meal per day including lean protein and vegetables<br>|
| Active Comparator: Dietary Counseling<br> | Behavioral: Dietary Counseling<br>* Dietary Counseling<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change in PDUS | Change in Synovitis measure using Ultrasound | change from baseline to 6 and 12 months | 
| change in DAS28 | Change in DAS28 represents conventional measure of reduced disease activity | change from baseline to 6 and 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| MBDA | Biomarker | Baseline, 6 weeks and 12 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Rheumatoid Arthritis (RA), Musculoskeletal Ultrasound (MSUS)