Anti-Inflammatory Dietary Intervention for Rheumatoid Arthritis

NCT05291299 | Unknown

• 1 other identifier: 227188
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

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.

Conditions

Rheumatoid Arthritis

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (10)

• Patient reported outcomes

  8 weeks

• Patient reported outcomes

  52 weeks

• Patient reported outcomes

  8 weeks

• Patient reported outcomes

  52 weeks

• Anthropometric measurements

  8 weeks

Study Arms (2)

Standard of Care (Control Group)

OTHER

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

Anti-inflammatory Diet (Intervention Group)

EXPERIMENTAL

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

Interventions

Anti-inflammatory diet BEHAVIORAL

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.

Anti-inflammatory Diet (Intervention Group)

Control/Standard of Care OTHER

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.

Standard of Care (Control Group)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Younger than 18 years.
• Unable to attend the 8 weekly nutrition appointment.
• History of documented eating disorders.

Sponsors & Collaborators

• Attune Health Research, Inc.: lead
• Cedars-Sinai Medical Center: collaborator

Study Sites (1)

Attune Health Research Inc

Beverly Hills, California, 90211, United States

RECRUITING

Related Publications (21)

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MeSH Terms

Conditions

Arthritis, Rheumatoid

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Central Study Contacts

Natalie Fortune, MS

CONTACT

3106520010; research.admin@attunehealth.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 27, 2022
• First Posted: March 22, 2022
• Study Start: July 5, 2022
• Primary Completion: December 1, 2024
• Study Completion: March 1, 2025
• Last Updated: July 19, 2023

Record last verified: 2023-07

Locations

US (1)