Anti-inflammatory Diet for Rheumatoid Arthritis

(RA-Diet Trial)

Overseen By Natalie Fortune, MS

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Attune Health Research, Inc.

Disqualifiers: Under 18, Eating disorders, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 13

Duration: 8 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how a specific anti-inflammatory diet might help people with rheumatoid arthritis (RA) manage their symptoms. Participants will either follow a typical Mediterranean diet, a type of anti-inflammatory dietary intervention, or try an elimination diet, which involves removing certain foods and slowly reintroducing them under a dietitian's guidance. The goal is to determine if these diets can reduce disease activity, such as flare-ups or medication use. This trial could suit adults with RA experiencing low to high disease activity who are open to dietary changes. As an unphased trial, it offers a unique opportunity for participants to explore innovative dietary approaches to managing RA symptoms.

Do I have to stop taking my current medications for this trial?

The trial protocol does not specify whether you need to stop taking your current medications. It seems likely that you can continue them, but you should confirm with the trial organizers.

What prior data suggests that this dietary intervention is safe for individuals with rheumatoid arthritis?

Research shows that anti-inflammatory diets can be safe and beneficial for people with rheumatoid arthritis (RA). Studies have found that these diets can significantly reduce pain compared to regular diets. For instance, one study discovered that an anti-inflammatory diet led to lower pain levels, with participants experiencing much less discomfort.

Similarly, another study found that diets like the Mediterranean diet, which is anti-inflammatory, resulted in less pain and better outcomes for those with RA. Overall, this evidence suggests that following an anti-inflammatory diet is generally well-tolerated and may help manage RA symptoms without causing serious side effects. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike traditional treatments for rheumatoid arthritis, which often involve medications like NSAIDs, DMARDs, or biologics, the anti-inflammatory diet being studied offers a food-based approach to managing the disease. This diet is distinctive because it involves an individualized elimination diet supervised by a Registered Dietitian, aiming to reduce inflammation naturally through tailored nutrition. Researchers are excited about this method as it empowers patients with dietary choices that may complement or even reduce the need for medications, potentially leading to fewer side effects and a more holistic treatment strategy.

What evidence suggests that this anti-inflammatory diet could be effective for rheumatoid arthritis?

Research has shown that certain diets can help reduce pain for people with rheumatoid arthritis (RA). One study found that these diets significantly lowered pain levels compared to regular diets. In this trial, participants in the control group will follow a Mediterranean diet, known for reducing inflammation and rich in vegetables and fruits, which may help manage RA symptoms. Meanwhile, the intervention group will follow an individualized elimination diet, supervised by a Registered Dietitian, to assess its impact on RA symptoms. Elimination diets, which remove certain foods to see if symptoms improve, have shown benefits for people with autoimmune diseases like RA. These findings suggest that dietary changes could be a promising way to manage RA symptoms. ^{1 2 6 7 8}

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

Able to read and write in English

I have been diagnosed with RA by a specialist.

My disease is active, and my doctor believes treatment could help.

Exclusion Criteria

History of documented eating disorders

I am under 18 years old.

I cannot attend the 8 weekly nutrition appointments.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Baseline

Baseline assessments including informed consent, medical history, physical exam, and initial nutrition education

1 day

1 visit (in-person)

Treatment

Participants follow an 8-week nutrition program with individualized elimination diet and systematic food reintroduction

8 weeks

7 visits (virtual)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including disease activity and anthropometric measurements

44 weeks

4 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Anti-inflammatory diet

Trial Overview

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.

How Is the Trial Designed?

Group I: Standard of Care (Control Group) Experimental Treatment 1 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 Treatment 1 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.

Who Is Running the Clinical Trial?

Attune Health Research, Inc.

Lead Sponsor

Trials

6

Recruited

1,600+

Cedars-Sinai Medical Center

Collaborator

Trials

523

Recruited

165,000+

Published Research Related to This Trial

In a 12-week randomized trial involving 154 overweight and obese patients with rheumatoid arthritis, the Mediterranean diet (MD) significantly reduced disease activity scores (DAS 28) compared to a low-fat high-carbohydrate diet and control group, indicating better management of RA symptoms.

The MD led to a 76% reduction in DAS 28 scores, demonstrating its effectiveness in reducing pain and inflammation in RA patients, regardless of weight loss outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dietary Pattern or Weight Loss: Which One Is More Important to Reduce Disease Activity Score in Patients with Rheumatoid Arthritis? A Randomized Feeding Trial. Sadeghi, A., Tabatabaiee, M., Mousavi, MA., et al.[2023]

In a study involving 174,638 women from the Nurses' Health Study, researchers found no significant link between adherence to a Mediterranean diet and the risk of developing rheumatoid arthritis (RA) over a follow-up period of 3,511,050 person-years.

The analysis showed that even women with the highest adherence to the Mediterranean dietary pattern had a hazard ratio of 0.98 for RA risk, indicating no meaningful difference compared to those with the lowest adherence, suggesting that this diet may not influence RA risk in women.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mediterranean diet and incidence of rheumatoid arthritis in women. Hu, Y., Costenbader, KH., Gao, X., et al.[2022]

A review of studies on the Mediterranean diet (MD) and its impact on rheumatoid arthritis (RA) found low evidence supporting its effectiveness in preventing or managing RA.

Adherence to the Mediterranean diet does not seem to significantly affect rheumatoid arthritis indices, suggesting that dietary changes may not be a key factor in RA treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Let Food Be Thy Medicine: The Case of The Mediterranean Diet in Rheumatoid Arthritis. Vranou, P., Gkoutzourelas, A., Athanatou, D., et al.[2020]

In a study of 120 rheumatoid arthritis patients, those who adhered more closely to the Mediterranean Diet showed significantly lower disease activity and functional disability, as indicated by lower Disease Activity Score (DAS28-CRP), Rheumatoid Arthritis Impact of Disease (RAID), and Health Assessment Questionnaire (HAQ) scores.

Higher adherence to the Mediterranean Diet reduced the odds of having a higher DAS28 score by 70%, suggesting that dietary choices can play a crucial role in managing rheumatoid arthritis symptoms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Mediterranean diet, and not dietary inflammatory index, is associated with rheumatoid arthritis disease activity, the impact of disease and functional disability. Charneca, S., Ferro, M., Vasques, J., et al.[2023]

Patients with rheumatoid arthritis (RA) following a Mediterranean diet showed significant improvements in disease activity, physical function, and vitality over 12 weeks, with a notable decrease in the disease activity score (DAS28) by 0.56 (p<0.001).

In contrast, patients on a Western diet did not experience significant changes, highlighting the potential of the Mediterranean diet as an effective dietary intervention for managing RA symptoms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An experimental study of a Mediterranean diet intervention for patients with rheumatoid arthritis. Sköldstam, L., Hagfors, L., Johansson, G.[2022]

The Mediterranean diet has shown beneficial effects in managing rheumatoid arthritis, with two studies reporting significant improvements in pain levels and physical function (p < 0.05).

While some evidence suggests the diet may help reduce disease activity, there is not enough data to recommend it for the prevention of rheumatoid arthritis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effects of the Mediterranean diet on rheumatoid arthritis prevention and treatment: a systematic review of human prospective studies. Forsyth, C., Kouvari, M., D'Cunha, NM., et al.[2019]

The Mediterranean diet may have little to no impact on pain or disease activity in rheumatoid arthritis patients, with a slight potential increase in weight, but the evidence supporting these conclusions is of low certainty.

There is insufficient evidence to determine the effects of the Mediterranean diet on functionality, morning stiffness, or quality of life in rheumatoid arthritis, as the certainty of the evidence is assessed as very low.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of Mediterranean diet on the treatment of rheumatoid arthritis. Porras, M., Rada, G., Durán, J.[2020]

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