NCT05291299

Anti-Inflammatory Dietary Intervention for Rheumatoid Arthritis

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 32 (estimated)
• Sponsor: Attune Health Research, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Rheumatoid Arthritis

Interventions

Type	Name	Description
BEHAVIORAL	Anti-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.
OTHER	Control/Standard of Care	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.

Timeline

• Start date: 2022-07-05
• Primary completion: 2024-12-01
• Completion: 2025-03-01
• First posted: 2022-03-22
• Last updated: 2023-07-19

Locations

1 site across 1 country: United States