Rheumatoid Arthritis
Conditions
Brief summary
The primary objective of this study is to assess if there is a significant difference in the mean disease activity score in individuals with RA participating in a dietary intervention compared to those in the control group measured by DAS-28. Other measures to track disease activity will include monitoring number and severity of disease flares and any changes in medications. This will be done by completing a single-blinded randomized controlled trial, parallel in design. The study population will consist of adults diagnosed with Seropositive and Seronegative RA based on the American College of Rheumatology criteria. Participants will have low, moderate, or high disease activity based on DAS-28 where the investigator feels that they can see improvement from a dietary intervention.
Detailed description
Per the Schedule of Assessments, upon enrollment, participants will be required to come in for a total of five on site visits. The first visit, also known as the baseline visit, will require participants to provided informed consent after all eligibility criteria is met. Subsequently, participants' Demographics, Medical History, EULAR/ACR classification, and physicians' assessments will be documented. Participants' vital signs will be checked and a thorough physical exam will also be performed after which safety labs will be drawn in addition to a routine urinalysis. Participants will complete outcome surveys and a food frequency questionnaire. Participants' body composition will be measured. Concomitant medications will be reviewed. Each participant will receive nutrition education from an approved MD or a consultation with an approved RD depending on the group to which they have been randomized. Participants who receive consultations with an RD will have seven follow up visits after the baseline visit.
Interventions
BEHAVIORALAnti-inflammatory diet
Patients randomized to the intervention group will work with a registered dietitian to create an individualized diet program to help reduce inflammation and Rheumatoid arthritis related symptoms.
Patients randomized to the control group will be following standard of care where their doctor will instruct them to follow a Mediterranean diet and provides them with an instructional sheet.
Sponsors
Cedars-Sinai Medical Center
Attune Health Research, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age greater than 18 years. * Diagnosed RA by a rheumatologist determined by the 2010 ACR/EULAR Classification Criteria. * Low, moderate, or highly active disease state based on clinical assessment where the investigator feels there is potential to see a difference. * Able to read and write in English.
Exclusion criteria
* Younger than 18 years. * Unable to attend the 8 weekly nutrition appointment. * History of documented eating disorders.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Disease Activity | 8 weeks | Rheumatoid arthritis disease activity Measured by Disease Activity Score-28, higher score is associated with increased disease activity. a Disease Activity Score greater than 5.1 indicated very active disease while a Disease Activity Score that is lower than 2.6 indicates disease remission |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Patient reported outcomes | 8 weeks | change in patient reported disease related outcomes measured by Health Assessment Questionaire-Disability Index, where a higher score indicates lower quality of health. A 0 indicates no difficulty in task performance while a score of 3 indicates much difficulty in task performance |
| Anthropometric measurements | 8 weeks | Assess the change in anthropometric measurements by weight |
Countries
United States
Contacts
Primary ContactNatalie Fortune, MS
Outcome results
None listed