Ultrasound Assessment of Rheumatoid Arthritis Patients Who Changed Diet

NCT02881307 | Completed

• 1 other identifier: Weight Loss Ultrasound RA Proj
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Rheumatoid Arthritis; Overweight

Keywords

Rheumatoid Arthritis (RA); Musculoskeletal Ultrasound (MSUS)

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• MBDA

  Baseline, 6 weeks and 12 weeks

Study Arms (2)

Dietary Supplement

EXPERIMENTAL

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

Dietary Counseling

ACTIVE COMPARATOR

Behavioral: Dietary Counseling

Interventions

Whey Protein&Prebiotic Supplement DIETARY_SUPPLEMENT

Dietary supplement (protein drink) commercially available protein shakes

Dietary Supplement

Dietary Counseling BEHAVIORAL

Dietary Counseling

Dietary Counseling

Dietary recommendations BEHAVIORAL

recommendations for one meal per day including lean protein and vegetables

Dietary Supplement

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Veena Ranganath, MD, MS: lead

Study Sites (1)

UCLA David Geffen School of Medicine, Division of Rheumatology

Los Angeles, California, 90095, United States

Location

Related Publications (1)

• Ranganath VK, La Cava A, Vangala S, Brook J, Kermani TA, Furst DE, Taylor M, Kaeley GS, Carpenter C, Elashoff DA, Li Z. Improved outcomes in rheumatoid arthritis with obesity after a weight loss intervention: randomized trial. Rheumatology (Oxford). 2023 Feb 1;62(2):565-574. doi: 10.1093/rheumatology/keac307.

  PMID: 35640116 DERIVED

MeSH Terms

Conditions

Arthritis, Rheumatoid; Overweight

Interventions

Nutrition Assessment

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Epidemiologic Measurements; Public Health; Environment and Public Health

Study Officials

• Veena K Ranganath, M.D., M.S.

  University of California, Los Angeles

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Ultrasonographer and joint assessor are blinded to the diet intervention and to each others assessments.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Clinical Professor

Model Details: Randomized Controlled Clinical Trial

Study Record Dates

• First Submitted: August 19, 2016
• First Posted: August 26, 2016
• Study Start: October 1, 2016
• Primary Completion: May 1, 2022
• Study Completion: May 1, 2022
• Last Updated: May 20, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)