Ultrasound Assessment of Rheumatoid Arthritis Patients Who Changed Diet

• Register: ClinicalTrials.gov
• Last refreshed on: 30 May 2022
• Main ID: NCT02881307
• Date of registration: 19/08/2016
• Prospective Registration: Yes
• Primary sponsor: Veena Ranganath, MD, MS
• Public title: Ultrasound Assessment of Rheumatoid Arthritis Patients Who Changed Diet
• Scientific title: Ultrasound Assessment of Rheumatoid Arthritis Patients Who Changed Diet
• Date of first enrolment: October 2016
• Target sample size: 40
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02881307
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Other. Masking: Triple (Care Provider, Investigator, Outcomes Assessor).
• Phase: N/A

Countries of recruitment

United States

Contacts

• Name: Veena K Ranganath, M.D., M.S.
• Affiliation: University of California, Los Angeles

Key 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



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Rheumatoid Arthritis

Overweight

Intervention(s)

Dietary Supplement: Whey Protein&Prebiotic Supplement

Behavioral: Dietary recommendations

Behavioral: Dietary Counseling

Primary Outcome(s)

change in DAS28 [Time Frame: change from baseline to 6 and 12 months]

change in PDUS [Time Frame: change from baseline to 6 and 12 months]

Secondary Outcome(s)

MBDA [Time Frame: Baseline, 6 weeks and 12 weeks]

Secondary ID(s)

Weight Loss Ultrasound RA Proj

Source(s) of Monetary Support

Please refer to primary and secondary sponsors