NCT02881307

Ultrasound Assessment of Rheumatoid Arthritis Patients Who Changed Diet

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: Veena Ranganath, MD, MS · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Rheumatoid Arthritis
• Overweight

Interventions

Type	Name	Description
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

Timeline

• Start date: 2016-10-01
• Primary completion: 2022-05-01
• Completion: 2022-05-01
• First posted: 2016-08-26
• Last updated: 2022-05-20

Locations

1 site across 1 country: United States