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Anti-inflammatory Diet for Rheumatoid Arthritis (RA-Diet Trial)

N/A

Recruiting

Research Sponsored by Attune Health Research, Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Diagnosed RA by a rheumatologist determined by the 2010 ACR/EULAR Classification Criteria

Age greater than 18 years

Must not have

Younger than 18 years

Unable to attend the 8 weekly nutrition appointment

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 52 weeks

Awards & highlights

No Placebo-Only Group

Summary

This trial is designed to see if there is a difference in disease activity scores for people with RA who participate in a dietary intervention, compared to those who don't. The study population will consist of adults with RA, who will be monitored for disease activity.

Who is the study for?

Adults over 18 with Rheumatoid Arthritis (RA), as diagnosed by a rheumatologist, who have varying levels of disease activity and can potentially benefit from dietary changes. Participants must be able to read and write in English but cannot join if they're under 18, unable to attend weekly nutrition meetings, or have a history of eating disorders.

What is being tested?

The trial is testing whether an anti-inflammatory diet can reduce disease activity in RA patients compared to standard care. It's a single-blinded study where participants are randomly assigned to the diet group or control group without knowing which one they're in.

What are the potential side effects?

Since this trial involves dietary changes rather than medication, side effects may include adjustments in digestion or food sensitivities. However, significant adverse effects are not typically expected from such interventions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have been diagnosed with RA by a specialist.

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I am older than 18 years.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am under 18 years old.

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I cannot attend the 8 weekly nutrition appointments.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 52 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~52 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 52 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Disease Activity

Secondary study objectives

Anthropometric measurements

Patient reported outcomes

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Group I: Standard of Care (Control Group)Experimental Treatment1 Intervention

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.

Group II: Anti-inflammatory Diet (Intervention Group)Experimental Treatment1 Intervention

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.

0 / 4Eligibility criteria met