Anti-Inflammatory Dietary Intervention for Rheumatoid Arthritis
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Rheumatoid Arthritis
- Sponsor
- Attune Health Research, Inc.
- Enrollment
- 32
- Locations
- 1
- Primary Endpoint
- Disease Activity
- Status
- Recruiting
- Last Updated
- 2 years ago
Overview
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.
Investigators
Swamy Venuturupalli
Principal Investigator
Attune Health Research, Inc.
Eligibility Criteria
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.
Outcomes
Primary Outcomes
Disease Activity
Time Frame: 52 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 Outcomes
- Anthropometric measurements(52 weeks)
- Patient reported outcomes(52 weeks)