Diet Intervention for Juvenile Arthritis

(DIGEST-JA Trial)

Recruiting at 7 trial locations

Overseen By Hayyah Clairman

Age: < 65

Sex: Any

Trial Phase: Academic

Sponsor: The Hospital for Sick Children

Must be taking: Dmards, Corticosteroids

Disqualifiers: Food allergies, Celiac, Type I diabetes, others

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

Compensation: Varies

Number of Visits: 3

54 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if a diet based on Mediterranean principles (Mediterranean Diet) can improve juvenile arthritis in children. Researchers are particularly interested in whether changes in the gut microbiome (the bacteria and other organisms in the intestines) contribute to improvements in the condition. Children with juvenile idiopathic arthritis (excluding certain types) who are on stable treatment may be suitable for this trial. Participants will follow the diet for 8 weeks, with an option for an additional 4 weeks, and provide stool and blood samples to assess any changes. The study's findings could guide larger future research and help families better understand dietary impacts on arthritis. As an unphased trial, this study offers families a chance to contribute to groundbreaking research on diet and juvenile arthritis.

Will I have to stop taking my current medications?

The trial does not require you to stop taking your current medications. Participants must be on stable treatment, meaning their medication should not have changed for 8 weeks and is unlikely to change for 12 weeks.

What prior data suggests that this diet is safe for children with arthritis?

Studies have shown that the Mediterranean diet is generally easy to follow and is linked to health benefits. Research indicates that people who follow this diet often have a lower risk of developing osteoarthritis and may experience milder symptoms if they do develop it.

One study found that about half of the parents whose children tried special diets, including the Mediterranean diet, noticed improvements in their children’s pain or joint swelling. This suggests that dietary changes might help alleviate symptoms of juvenile arthritis.

Reports of negative effects from the Mediterranean diet are rare, making it a seemingly safe choice for many. However, consulting a healthcare provider before making significant dietary changes is advisable, especially for children with medical conditions. ^{1 2 3 4 5}

Why are researchers excited about this trial?

The Mediterranean Diet is unique because it offers a natural and holistic approach to managing juvenile arthritis, focusing on anti-inflammatory foods rather than medications. Unlike typical treatments that often include NSAIDs or biologics, this diet emphasizes fruits, vegetables, whole grains, and healthy fats, which can help reduce inflammation. Researchers are excited about this treatment because it not only targets inflammation but also promotes overall health and well-being without the side effects commonly associated with pharmaceuticals.

What evidence suggests that the Mediterranean Diet might be an effective treatment for juvenile arthritis?

Research has shown that the Mediterranean Diet can help with arthritis. One study found that people with rheumatoid arthritis who followed this diet experienced less inflammation and improved mobility. Another study discovered that adherence to this diet enhanced knee and hip movement. Although less information exists about its effects on juvenile arthritis, these findings suggest potential benefits, as the diet can alter gut bacteria, influencing the immune system. In this trial, participants will follow the Mediterranean Diet to evaluate its potential to improve symptoms of juvenile arthritis by reducing inflammation and supporting gut health. ^{1 6 7 8 9}

Who Is on the Research Team?

Brian M. Feldman

Principal Investigator

The Hospital for Sick Children

Are You a Good Fit for This Trial?

This trial is for children with juvenile arthritis. Participants will try a Mediterranean-based diet to see if it improves their condition. They must be willing to change their diet, provide stool and blood samples, and complete health questionnaires at specified times during the study.

Inclusion Criteria

I have been diagnosed with JIA, but not the systemic or enthesitis-related types, nor RF positive polyarthritis.

My current treatment for arthritis has been stable for 8 weeks and won't change soon.

Willingness to provide stool samples

Exclusion Criteria

Documented specific food allergies, celiac disease

Co-morbidities that might impact the tolerability of the study diet, e.g., type I diabetes, peptic ulcer disease, etc.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Diet Intervention

Participants change their diet based on the Mediterranean Diet principles for 8 weeks

8 weeks

3 visits (in-person) at beginning, 8 weeks, and 12 weeks

Optional Extension

Participants have the option to continue the diet for an additional 4 weeks

4 weeks

Follow-up

Participants are monitored for changes in disease activity and microbiome

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Mediterranean Diet

Trial Overview The study tests whether a Mediterranean Diet can improve juvenile arthritis by altering the gut microbiome. Fifty-four participants will follow this diet for 8 weeks, with an optional extension of 4 more weeks, while providing samples and information for analysis.

How Is the Trial Designed?

Group I: Intervention Experimental Treatment 1 Intervention

Diet (MedDiet)

Who Is Running the Clinical Trial?

The Hospital for Sick Children

Lead Sponsor

Trials

724

Recruited

6,969,000+

Canadian Institutes of Health Research (CIHR)

Collaborator

Trials

1,417

Recruited

26,550,000+

Published Research Related to This Trial

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]

In a study of 205 rheumatoid arthritis patients, adherence to the Mediterranean diet was linked to improved health outcomes, including better scores on the RA Impact of Disease (RAID), patient global assessment (PGA), and general health (GH).

While the Mediterranean diet showed potential benefits for overall well-being in RA patients, it did not significantly correlate with lower disease activity scores, suggesting that while diet may help with certain symptoms, it may not directly impact the severity of the disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adherence to Mediterranean diet and patient perception of rheumatoid arthritis. Ingegnoli, F., Schioppo, T., Scotti, I., et al.[2021]

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]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11614952/

Mediterranean diet and osteoarthritis: an update - PMC The 16 weeks dietary intervention was associated with improvement on knee and hip mobility, modest reductsion in cartilage degradation, ...

2. nature.com nature.com/articles/s41430-025-01628-8

Mediterranean diet and rheumatoid arthritis: A nine-year ... This study aimed to examine the association between adherence to MD and the risk of developing rheumatoid arthritis RA.

3. sciencedirect.com sciencedirect.com/science/article/abs/pii/S000349672409068X

An experimental study of a Mediterranean diet intervention ... The results indicate that patients with RA, by adjusting to a Mediterranean diet, did obtain a reduction in inflammatory activity, an increase in physical ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9806873/

a systematic review and meta-analysis - PMC The association between diet, symptoms and health related quality of life in children and young people with Juvenile idiopathic arthritis (JIA) is not clearly ...

5. rheumatologyadvisor.com rheumatologyadvisor.com/news/proposed-study-aims-to-assess-mediterranean-diet-efficacy-for-rheumatoid-arthritis/

Proposed Study Aims to Assess Mediterranean Diet ... Primary outcome measures include change in participants' quality of life (using the Rheumatoid Arthritis Quality of Life instrument) and ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9610591/

An Overview of Nutritional Aspects in Juvenile Idiopathic ... About 50% of parents whose children adopted special diets perceived improvement in pain or joint swelling. When looking at medication changes ...

7. researchgate.net researchgate.net/publication/388335391_Exploring_nutritional_risks_of_the_specific_carbohydrate_diet_food_and_nutrient_intake_in_children_with_juvenile_idiopathic_arthritis

Exploring nutritional risks of the specific carbohydrate diet PDF | Diet is considered a key research priority for juvenile idiopathic arthritis (JIA), garnering considerable interest from affected families.

8. mjrheum.org mjrheum.org/sept-2020/newsid792/259/showfulltext792/1

The Case of The Mediterranean Diet in Rheumatoid Arthritis The present review discusses the major findings of the clinical studies conducted in patients suffering from RA. ADHERENCE TO THE MD AND RISK FOR DEVELOPING RA.

9. mdpi.com mdpi.com/2072-6643/10/8/1030

Osteoarthritis and the Mediterranean Diet: A Systematic ... In conclusion, the three studies included in this systematic review demonstrated some relation between osteoarthritis and a Mediterranean diet. However, ...