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: Unknown

32 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

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 data supports the idea that Anti-inflammatory Diet for Rheumatoid Arthritis is an effective treatment?

The available research shows that the Mediterranean diet, a type of anti-inflammatory diet, can be effective for people with rheumatoid arthritis. One study found that patients following the Mediterranean diet had improvements in joint pain and swelling compared to those on a low-fat diet or their regular diet. Another review highlighted that some studies reported improvements in pain levels for those on the Mediterranean diet. However, one review noted that the overall evidence is low, and the diet may not significantly affect all measures of rheumatoid arthritis. Compared to other diets, the Mediterranean diet seems to offer some benefits in reducing symptoms. ^{1 2 3 4 5}

What safety data exists for the anti-inflammatory diet in treating rheumatoid arthritis?

The studies reviewed primarily focus on the efficacy of the Mediterranean diet in managing rheumatoid arthritis, with no specific mention of safety concerns. The diet is generally considered safe and is often used as a complementary approach to pharmacotherapy. However, the evidence on its impact on rheumatoid arthritis indices is low, and no adverse effects were reported in the studies. ^{1 2 4 5 6}

Is the Anti-inflammatory diet a promising treatment for Rheumatoid Arthritis?

Yes, the Anti-inflammatory diet, also known as the Mediterranean diet, shows promise as a treatment for Rheumatoid Arthritis. Studies suggest it can help reduce pain and improve joint health. ^{1 2 4 5 7}

Eligibility Criteria

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.

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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 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]

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]

References

1. India 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. [2023]

2. Germany pubmed.ncbi.nlm.nih.gov

The effects of the Mediterranean diet on rheumatoid arthritis prevention and treatment: a systematic review of human prospective studies. [2019]

3. Germany 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. [2023]

4. England pubmed.ncbi.nlm.nih.gov

An experimental study of a Mediterranean diet intervention for patients with rheumatoid arthritis. [2022]

5. Greece pubmed.ncbi.nlm.nih.gov

Let Food Be Thy Medicine: The Case of The Mediterranean Diet in Rheumatoid Arthritis. [2020]

6. United States pubmed.ncbi.nlm.nih.gov

Mediterranean diet and incidence of rheumatoid arthritis in women. [2022]

7. Chile pubmed.ncbi.nlm.nih.gov

Effects of Mediterranean diet on the treatment of rheumatoid arthritis. [2020]