Anti-Inflammatory Dietary Intervention for Rheumatoid Arthritis

Study Overview
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Brief Summary
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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
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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.

Official Title
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Anti-Inflammatory Dietary Intervention for Rheumatoid Arthritis

Conditions
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Rheumatoid Arthritis

Intervention / Treatment
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* Behavioral: Anti-inflammatory diet
* Other: Control/Standard of Care


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Standard of Care (Control Group)<br>Physicians will follow standard of care and instruct participants in the control group to follow a Mediterranean diet higher in vegetables and fruits[19]. Patients will be provided with a handout detailing the basics of the Mediterranean diet. At follow up visits, physicians will ask participants about how they have been eating and if they have been following the guidelines. | Other: Control/Standard of Care<br>* 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.<br>|
| Experimental: Anti-inflammatory Diet (Intervention Group)<br>An 8-week nutrition program consisting of an individualized elimination diet and systematic food reintroduction implemented and supervised by a Registered Dietitian. Clinical trials have shown some benefit from elimination diets for individuals with autoimmune disease [18]. The specifics of the elimination diet including duration and foods included will be individual and up to the RDs discretion based on the patient's medical and diet history, willingness, current diet, preferences, goals, and ability. The initial diet instruction with a Registered Dietitian will be a one-hour, individual secure video call, with nutrition evaluation/assessment and education on elimination diet protocol. Follow up visits will be approximately 20-30 minutes for the subsequent 7 weeks. | Behavioral: Anti-inflammatory diet<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Disease Activity | 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 | 8 weeks | 
| Disease Activity | 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 | 52 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient reported outcomes | 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 | 8 weeks | 
| Patient reported outcomes | 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 | 52 weeks | 
| Patient reported outcomes | change in patient reported disease related outcomes measured by Physical and Mental Health Summary Score (PROMIS-29) where a score of 0 indicates excellent mental and physical health while a score of 10 indicates poor mental and physical health. | 8 weeks | 
| Patient reported outcomes | change in patient reported disease related outcomes measured by Physical and Mental Health Summary Score (PROMIS-29) where a score of 0 indicates excellent mental and physical health while a score of 10 indicates poor mental and physical health. | 52 weeks | 
| Anthropometric measurements | Assess the change in anthropometric measurements by weight | 8 weeks | 
| Anthropometric measurements | Assess the change in anthropometric measurements by weight | 52 weeks | 
| Anthropometric measurements | Assess the change in anthropometric measurements by body fat percentage (waist circumference) | 8 weeks | 
| Anthropometric measurements | Assess the change in anthropometric measurements by body fat percentage (waist circumference) | 52 weeks | 
| Anthropometric measurements | Assess the change in anthropometric measurements by waist/hip ratio | 8 weeks | 
| Anthropometric measurements | Assess the change in anthropometric measurements by waist/hip ratio | 52 weeks |