Recruiting

Dietary Intervention

Sponsor:

Attune Health Research, Inc.

Code:

NCT05291299

Conditions

Rheumatoid Arthritis

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Anti-inflammatory diet

Control/Standard of Care

Study Details

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

Study ID

NCT05291299

Start date

Jul 5, 2022

Status verified date

Jul, 2023

Completion date

Mar, 2025

Anticipated

Primary completion date

Dec, 2024

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Enrollment

32 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

other: Standard of Care (Control Group)

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.

experimental: Anti-inflammatory Diet (Intervention Group)

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.

Interventions

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.

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.

Primary outcome measure

  • Disease Activity [ Time Frame: 8 weeks ]
  • Disease Activity [ Time Frame: 52 weeks ]

Central Contacts and Locations

Central contacts

Natalie Fortune, MS

3106520010research.admin@attunehealth.com

Locations

Attune Health Research Inc

Recruiting

Beverly Hills, California, United States, 90211

Contacts

Natalie Fortune, MS

131-065-2001research.Admin@attunehealth.com

More Information

Sponsor

Attune Health Research, Inc.

Last update posted

Jul 19, 2023

Last verified

Jul, 2023

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Attune Health Research, Inc. on 2023-07-19.