Ultrasound Assessment of Rheumatoid Arthritis Patients Who Changed Diet

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-10-31

Study Completion Date

2022-05-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

The Effect of a Plant-based Diet on the Active Rheumatoid Arthritis Activity.

NCT05911880

Rheumatoid Arthritis Diet, Healthy Inflammatory Response

UNKNOWN NA

Ultrasonography as a Biomarker in Early Rheumatoid Arthritis

NCT00781989

Rheumatoid Arthritis

COMPLETED

A Nutrition Intervention for Arthritis -2

NCT01700881

Rheumatoid Arthritis

COMPLETED NA

A Nutritional Intervention for Arthritis

NCT01544101

Rheumatoid Arthritis

COMPLETED NA

Rheumatoid Arthritis Coping Enhancement

NCT04246827

Rheumatoid Arthritis Obesity Pain

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Rheumatoid Arthritis Overweight

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Randomized Controlled Clinical Trial

Primary Study Purpose

OTHER

Blinding Strategy

TRIPLE

Caregivers Investigators Outcome Assessors

Ultrasonographer and joint assessor are blinded to the diet intervention and to each others assessments.

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Dietary Supplement

Group Type EXPERIMENTAL

Whey Protein&Prebiotic Supplement

Intervention Type DIETARY_SUPPLEMENT

Dietary supplement (protein drink) commercially available protein shakes

Dietary recommendations

Intervention Type BEHAVIORAL

recommendations for one meal per day including lean protein and vegetables

Dietary Counseling

Group Type ACTIVE_COMPARATOR

Dietary Counseling

Intervention Type BEHAVIORAL

Dietary Counseling

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Whey Protein&Prebiotic Supplement

Dietary supplement (protein drink) commercially available protein shakes

Intervention Type DIETARY_SUPPLEMENT

Dietary Counseling

Intervention Type BEHAVIORAL

Dietary recommendations

recommendations for one meal per day including lean protein and vegetables

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No