Ultrasound Assessment of Rheumatoid Arthritis Patients Who Changed Diet

Veena Ranganath, MD, MS

Status: Completed

Conditions: Overweight; Rheumatoid Arthritis

Treatments: Behavioral: Dietary recommendations; Dietary Supplement: Whey Protein&Prebiotic Supplement; Behavioral: Dietary Counseling

Study type: Interventional

Funder types: Other

Identifiers

NCT02881307

Weight Loss Ultrasound RA Proj

Details and patient eligibility

About

The purpose of this research study is to evaluate if a weight loss intervention will improve your rheumatoid arthritis disease activity.

Full 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).

Enrollment: 40 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Patient must meet 1987 ACR (American College of Rheumatology) criteria
2. Age > 18 years of age
3. Baseline DAS28/ESR>3.2 (ESR-erythrocyte sedimentation rate)
4. Stable DMARDs or biologic therapy for at least 12 weeks, or stable off RA therapy 12 weeks.
5. Willingness to participate in a weight loss program
6. BMI > 30
7. Prednisone ≤ 10 mg
8. Patient has provided informed consent

Exclusion criteria

1. Major surgery (including joint surgery) within 8 weeks prior to baseline or planned major surgery within 3 months after baseline
2. Evidence of serious uncontrolled concomitant cardiovascular, nervous system, pulmonary, renal, hepatic, endocrine, or gastrointestinal disease
3. Known active current or history of recurrent bacterial, viral, fungal, mycobacterial or other infections (as this may falsely elevate biomarkers)
4. 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
5. Pregnant women or nursing (breast feeding) mothers
6. Neuropathies or other conditions that might interfere with pain evaluation unless related to primary disease under investigation
7. History of an eating disorder
8. History of bariatric surgery
9. EKG results deeming patient to unsafe for study intervention
10. Allergy to study intervention

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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40 participants in 2 patient groups

Dietary Supplement

Experimental group

Treatment:

Behavioral: Dietary recommendations

Dietary Supplement: Whey Protein&Prebiotic Supplement

Dietary Counseling

Active Comparator group

Treatment:

Behavioral: Dietary Counseling