Anti-Inflammatory Dietary Intervention for Rheumatoid Arthritis

Not Applicable

Recruiting

• Conditions: Rheumatoid Arthritis

• Registration Number: NCT05291299
• Lead Sponsor: Attune Health Research, Inc.

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.

Study Timeline

• Study First Submitted: 2022-01-27
• Study First Submitted QC: 2022-03-21
• Study First Posted: 2022-03-22
• Study Start: 2022-07-05
• Status Verified: 2023-07
• Last Update Submitted: 2023-07-18
• Last Update Posted: 2023-07-19
• Primary Completion: 2024-12
• Study Completion: 2025-03

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 32

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Disease Activity	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 Outcome Measures

Name	Time	Method
Patient reported outcomes	52 weeks	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.
Anthropometric measurements	52 weeks	Assess the change in anthropometric measurements by waist/hip ratio

Trial Locations

Locations (1)

Attune Health Research Inc; 🇺🇸 Beverly Hills, California, United States