Diet Intervention for Juvenile Arthritis

(DIGEST-JA Trial)

Recruiting at 6 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

Trial Summary

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 data supports the effectiveness of the Mediterranean Diet treatment for juvenile arthritis?

Research on rheumatoid arthritis, a condition similar to juvenile arthritis, shows that following a Mediterranean diet can help reduce disease activity and improve overall health. This suggests that the diet might also be beneficial for juvenile arthritis patients. ^{1 2 3 4 5}

Is the Mediterranean diet safe for people with arthritis?

The Mediterranean diet is generally considered safe for people, including those with arthritis, as it focuses on healthy foods like fruits, vegetables, whole grains, and healthy fats. ^{1 2 3 6 7}

How is the Mediterranean Diet treatment different from other treatments for juvenile arthritis?

The Mediterranean Diet is unique because it focuses on anti-inflammatory foods like fruits, vegetables, whole grains, and healthy fats, which may help reduce inflammation in juvenile arthritis without the side effects associated with drugs like methotrexate and glucocorticosteroids. ^{1 3 8 9 10}

What is the purpose of this trial?

Families of children with arthritis are highly interested in the benefits of diet to improve their child's disease and future health outcomes. Previous research shows that the germs - bacteria and other organisms - that live in the intestines (gut microbiome) are important to how well immune systems work, and that what people eat changes their gut microbiome. The investigators want to study whether a certain diet - based on the principles of the Mediterranean Diet - will improve arthritis for children and whether it was changes in the microbiome that led to improvement. Fifty-four participants in this study will change their diet for an 8-week period, and will have the option of remaining on the diet for an additional 4 weeks. At three time points during the study (beginning, 8 weeks, and 12 weeks), participants will provide stool and blood samples, will complete questionnaires about diet and other aspects of lifestyle and health, and will complete a disease assessment by a clinician. From collecting all these samples and information, the investigators will be able to determine if the diet was successful in improving disease activity in children with arthritis and if the gut microbiome was changed as well. This study will help the investigators figure out if a larger, and more definitive, study like this is possible to do in children with arthritis and will help the investigators design a bigger multinational study to confirm how diet affects disease outcomes and the microbiome in children with arthritis. If successful, this research will provide scientific knowledge to help families make their way through this difficult to- navigate topic.

Research Team

Brian M. Feldman

Principal Investigator

The Hospital for Sick Children

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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 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 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 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]

References

1. Brazil pubmed.ncbi.nlm.nih.gov

[Dietetic and anthropometric assessment in juvenile rheumatoid arthritis patients]. [2019]

2. England pubmed.ncbi.nlm.nih.gov

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

3. Uganda pubmed.ncbi.nlm.nih.gov

Body composition in children with juvenile idiopathic arthritis: effect of dietary intake of macronutrient: results from a cross sectional study. [2018]

4. 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]

5. Scotland pubmed.ncbi.nlm.nih.gov

Adherence to Mediterranean diet and patient perception of rheumatoid arthritis. [2021]

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

Dietary patterns and nutrient intake of individuals with rheumatoid arthritis and osteoarthritis in the United States. [2020]

7. 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]

8. Switzerland pubmed.ncbi.nlm.nih.gov

Nutritional Aspects of Juvenile Idiopathic Arthritis: An A to Z for Dietitians. [2023]

9. England pubmed.ncbi.nlm.nih.gov

A pilot study of possible anti-inflammatory effects of the specific carbohydrate diet in children with juvenile idiopathic arthritis. [2022]

10. Brazil pubmed.ncbi.nlm.nih.gov

Inadequate dietary intake of children and adolescents with juvenile idiopathic arthritis and systemic lupus erythematosus. [2020]