Rheumatoid ArthritisNCT02881307
Ultrasound Assessment of Rheumatoid Arthritis Patients Who Changed Diet
A study testing Whey Protein&Prebiotic Supplement, Dietary Counseling and Dietary recommendations in people with Rheumatoid Arthritis and Overweight, run by Veena Ranganath, MD, MS at 1 site in United States.
Trial summary
The purpose of this research study is to evaluate if a weight loss intervention will improve your rheumatoid arthritis disease activity. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rheumatoid Arthritis, Overweight
- What is being tested?
- Whey Protein&Prebiotic Supplement, Dietary Counseling and Dietary recommendations
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2016to May 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- History of an eating disorder
- History of bariatric surgery
- EKG results deeming patient to unsafe for study intervention
- Allergy to study intervention
Trial locations and contacts
1 site in 1 country.
United States1 site
UCLA David Geffen School of Medicine, Division of Rheumatology
Los Angeles, California, 90095
About this study
The purpose of this research study is to evaluate if a weight loss intervention will improve your rheumatoid arthritis disease activity.
Read the 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
- Being tested
- Whey Protein&Prebiotic Supplement, Dietary Counseling, Dietary recommendations
- Keywords
- Rheumatoid Arthritis (RA), Musculoskeletal Ultrasound (MSUS)
- Medical subject headings
- Arthritis, Rheumatoid, Overweight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Whey Protein&Prebiotic SupplementDietary supplement
Dietary supplement (protein drink) commercially available protein shakes
Dietary CounselingBehavioural
Dietary Counseling
Dietary recommendationsBehavioural
recommendations for one meal per day including lean protein and vegetables
| Study group | Role | What they receive |
|---|---|---|
| Dietary Supplement | Experimental | Not described Receives: Dietary Supplement: Whey Protein&Prebiotic Supplement; Behavioral: Dietary recommendations |
| Dietary Counseling | Active comparator | Not described Receives: Behavioral: Dietary Counseling |
What is being measured
The primary outcome is the main question the study is designed to answer.
change in PDUS
Change in Synovitis measure using Ultrasound
Measured: change from baseline to 6 and 12 months
change in DAS28
Change in DAS28 represents conventional measure of reduced disease activity
Measured: change from baseline to 6 and 12 months
Secondary outcomes (1)
MBDA
Biomarker
Measured: Baseline, 6 weeks and 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2016 (estimated)
- Study startOct 2016
- Primary completionMay 2022
- Study completionMay 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Rheumatoid ArthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized Controlled Clinical Trial
- Masking
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Veena Ranganath, MD, MS
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Veena Ranganath, MD, MS, University of California, Los Angeles
- Investigators
- Veena K Ranganath, M.D., M.S., Principal investigator, University of California, Los Angeles
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02881307
- Sponsor's protocol ID
- Weight Loss Ultrasound RA Proj
- Status last verified
- May 2022
- First submitted
- 19 Aug 2016
- Last updated
- 20 May 2022
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
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.
PubMed 35640116
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasound Assessment of Rheumatoid Arthritis Patients Who Changed Diet
- ClinicalTrials.gov ID
- NCT02881307
- Acronym / sponsor ID
- Weight Loss Ultrasound RA Proj
- Conditions
- Rheumatoid Arthritis, Overweight
- Keywords
- Rheumatoid Arthritis (RA), Musculoskeletal Ultrasound (MSUS)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Veena Ranganath, MD, MSUniversity, hospital or other
- Study start
- Oct 2016
- Primary completion
- May 2022 (actual)
- Study completion
- May 2022 (actual)
- First posted
- 26 Aug 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized Controlled Clinical Trial
| Arm | Type | Receives |
|---|---|---|
| Dietary Supplement | Experimental | Dietary Supplement: Whey Protein&Prebiotic Supplement, Behavioral: Dietary recommendations |
| Dietary Counseling | Active comparator | Behavioral: Dietary Counseling |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Whey Protein&Prebiotic SupplementDietary supplement (protein drink) commercially available protein shakes | Dietary supplement | Dietary Supplement |
| Dietary CounselingDietary Counseling | Behavioural | Dietary Counseling |
| Dietary recommendationsrecommendations for one meal per day including lean protein and vegetables | Behavioural | Dietary Supplement |
Primary outcome
change in PDUS
Time frame: change from baseline to 6 and 12 months
Change in Synovitis measure using Ultrasound
change in DAS28
Time frame: change from baseline to 6 and 12 months
Change in DAS28 represents conventional measure of reduced disease activity
1 secondary outcome
MBDA
Time frame: Baseline, 6 weeks and 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 May 2022.
- Derived from this study: PubMed 35640116Ranganath 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Veena K Ranganath, M.D., M.S. principal investigator
University of California, Los Angeles
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Whey Protein&Prebiotic Supplement, Dietary Counseling and Dietary recommendations in people with Rheumatoid Arthritis and Overweight, run by Veena Ranganath, MD, MS at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
change in PDUS (time frame: change from baseline to 6 and 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02881307, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 May 2022.