Ultrasound Assessment of Rheumatoid Arthritis Patients Who Changed Diet

Study Purpose

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

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 and Over
Gender	All

More Inclusion & Exclusion Criteria

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 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.	NCT02881307
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.	Dr. Veena Ranganath
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Veena K Ranganath, M.D., M.S.
Principal Investigator Affiliation	University of California, Los Angeles
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Recruiting
Countries	United States
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Rheumatoid Arthritis, Overweight

Additional Details

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).

Arms & Interventions

Arms

Experimental: Dietary Supplement

Active Comparator: Dietary Counseling

Interventions

Dietary Supplement: - Whey Protein&Prebiotic Supplement

Dietary supplement (protein drink) commercially available protein shakes

Behavioral: - Dietary Counseling

Dietary Counseling

Behavioral: - Dietary recommendations

recommendations for one meal per day including lean protein and vegetables

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.

Los Angeles, California

Status

Recruiting

Address

UCLA David Geffen School of Medicine, Division of Rheumatology

Los Angeles, California, 90095

Site Contact

Jennifer Raymond

[email protected]

310-206-4112

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