32 Participants Needed

Anti-inflammatory Diet for Rheumatoid Arthritis

(RA-Diet Trial)

NF
Overseen ByNatalie Fortune, MS
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Attune Health Research, Inc.
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Approved in 1 JurisdictionThis treatment is already approved in other countries

What You Need to Know Before You Apply

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 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.12345

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.12456

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.12457

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.
See 1 more

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?
2Treatment groups
Experimental Treatment
Group I: Standard of Care (Control Group)Experimental Treatment1 Intervention
Group II: Anti-inflammatory Diet (Intervention Group)Experimental Treatment1 Intervention

Find a Clinic Near You

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.
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.
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.
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]

Citations

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]
The effects of the Mediterranean diet on rheumatoid arthritis prevention and treatment: a systematic review of human prospective studies. [2019]
The Mediterranean diet, and not dietary inflammatory index, is associated with rheumatoid arthritis disease activity, the impact of disease and functional disability. [2023]
An experimental study of a Mediterranean diet intervention for patients with rheumatoid arthritis. [2022]
Let Food Be Thy Medicine: The Case of The Mediterranean Diet in Rheumatoid Arthritis. [2020]
Mediterranean diet and incidence of rheumatoid arthritis in women. [2022]
Effects of Mediterranean diet on the treatment of rheumatoid arthritis. [2020]
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