Mediterranean Diet for Inflammatory Bowel Disease

Overseen By Mehrnaz Aghili, M.D.

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of California, San Diego

Must not be taking: Antibiotics, Steroids

Disqualifiers: Drug abuse, Pregnancy, C difficile, others

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

Compensation: Varies

Number of Visits: 2

Duration: 6 weeks

90 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how a Mediterranean diet, rich in fruits, vegetables, and healthy fats, might benefit people with inflammatory bowel disease (IBD). Researchers aim to determine if adopting this diet can reduce inflammation, a common concern for those with IBD. Participants will undergo blood and stool tests to monitor changes in inflammation. This trial suits individuals with mild to moderate Crohn's Disease who have not recently changed their medication and are not on antibiotics. As an unphased trial, it offers a unique opportunity to contribute to understanding dietary impacts on IBD.

Will I have to stop taking my current medications?

The trial does not specify if you must stop taking your current medications, but it requires that you are on a stable dose of medications during the study. If your medication dose has changed recently, you may not be eligible to participate.

What prior data suggests that the Mediterranean Diet is safe for individuals with inflammatory bowel disease?

Research has shown that the Mediterranean diet is generally safe and easy for individuals with inflammatory bowel disease (IBD) to follow. Studies have found that this diet can reduce gut inflammation and improve the quality of life for those with IBD, such as Crohn's disease. Reports of negative side effects from this diet are rare. Overall, the Mediterranean diet is considered a helpful way to manage IBD symptoms, with a strong likelihood of providing benefits without causing harm. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike the standard treatments for Inflammatory Bowel Disease (IBD), which often include medications like corticosteroids and immunosuppressants, the Mediterranean Diet offers a dietary approach to managing the condition. This diet is rich in fruits, vegetables, whole grains, and healthy fats, which may help reduce inflammation naturally. Researchers are excited because this diet could potentially offer a non-pharmacological option that promotes overall health and well-being, possibly reducing the need for medication and its associated side effects.

What evidence suggests that the Mediterranean Diet might be an effective treatment for inflammatory bowel disease?

Research has shown that the Mediterranean diet, which participants in this trial will follow, benefits gut health and helps reduce inflammation in people with inflammatory bowel disease (IBD). Studies have found that this diet can significantly improve symptom frequency, leading to decreased symptoms. For example, one study found that people who followed this diet experienced a better quality of life and less disease activity. Another study reported that 96% of participants had fewer symptoms and less inflammation. Overall, the Mediterranean diet appears promising for managing IBD. ^{6 7 8 9 10}

Are You a Good Fit for This Trial?

This trial is for adults over 18 with mild to moderate Crohn's Disease, as indicated by specific disease activity and inflammation markers. Participants must not have started or changed their standard treatment recently, be on stable medication doses, and free from certain infections or antibiotic use.

Inclusion Criteria

I have mild to moderate Crohn's Disease with specific test results.

Exclusion Criteria

I started or changed my standard cancer treatment dose within the last 3 months.

Subjects with significant other medical or psychiatric comorbidities and/or medication use which in physician's clinical judgment might difficult the interpretation of the results

Known allergy to any component of the proposed diet

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants follow a Mediterranean Diet for 42 days, with blood and stool samples collected for analysis

6 weeks

2 visits (in-person) for sample collection

Follow-up

Participants are monitored for changes in disease state by measuring markers of inflammation

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Mediterranean Diet

Trial Overview

The study explores how a Mediterranean Diet affects individuals with Inflammatory Bowel Disease (IBD). It involves analyzing blood and stool samples before and after dietary changes to assess the impact on microbiome composition and inflammation levels in patients.

How Is the Trial Designed?

Group I: Mediterranean Diet Experimental Treatment 1 Intervention

Mediterranean Diet for 42 Days

Who Is Running the Clinical Trial?

University of California, San Diego

Lead Sponsor

Trials

1,215

Recruited

1,593,000+

Published Research Related to This Trial

The Mediterranean diet (MD), rich in plant foods and beneficial for gut health, may help improve the gut microbiota and reduce inflammation in patients with inflammatory bowel diseases (IBD).

Despite its potential benefits, adherence to the Mediterranean diet among IBD patients is low due to gastrointestinal symptoms, suggesting that a modified version of the diet, tailored to individual tolerances, could be a better approach for these patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Should the Mediterranean diet be recommended for inflammatory bowel diseases patients? A narrative review. Ratajczak, AE., Festa, S., Aratari, A., et al.[2023]

In a study of 100 children and adolescents with mild to moderate inflammatory bowel disease (IBD), those who adhered to the Mediterranean diet (MD) for 12 weeks showed significant improvements in disease activity and inflammatory markers compared to those on their usual diet.

Patients following the MD experienced earlier and greater reductions in clinical scores and inflammatory markers, indicating that the MD may be a beneficial dietary intervention for managing IBD in young patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adherence to the Mediterranean Diet Improved Clinical Scores and Inflammatory Markers in Children with Active Inflammatory Bowel Disease: A Randomized Trial. El Amrousy, D., Elashry, H., Salamah, A., et al.[2022]

In a study of 83 patients with inflammatory bowel disease, only 21.7% showed strong adherence to the Mediterranean diet, which was associated with lower disease activity and improved quality of life in those with ulcerative colitis.

While stronger adherence to the Mediterranean diet positively impacted quality of life and disease activity in ulcerative colitis patients, no significant effects were observed for Crohn's disease, indicating the need for further research on dietary interventions in inflammatory bowel disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Effect of Adherence to Mediterranean Diet on Disease Activity in Patients with Inflammatory Bowel Disease. Çelik, K., Güveli, H., Erzin, Y., et al.[2023]

In a 12-week study with 32 adults having quiescent Ulcerative Colitis, those following the Mediterranean diet pattern (MDP) showed significantly higher adherence and improved diet quality compared to those on the Canadian Habitual Diet.

Participants on the MDP experienced reductions in certain bowel symptoms, such as gas and tenesmus, without any reported adverse events, although nutritional inadequacies in key vitamins and minerals were noted, highlighting the need for tailored dietary education.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dietary adherence to the Mediterranean diet pattern in a randomized clinical trial of patients with quiescent ulcerative colitis. Haskey, N., Shim, RCK., Davidson-Hunt, A., et al.[2023]

In a study of 153 patients with ulcerative colitis after pouch surgery, adherence to the Mediterranean diet (MED) was linked to lower levels of fecal calprotectin, a marker of intestinal inflammation, suggesting that MED may help reduce inflammation in inflammatory bowel diseases.

Patients with normal pouch function who adhered more closely to the MED showed a trend towards a lower risk of developing pouchitis over an 8-year follow-up, indicating potential long-term benefits of the diet.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adherence to the Mediterranean diet is associated with decreased fecal calprotectin in patients with ulcerative colitis after pouch surgery. Godny, L., Reshef, L., Pfeffer-Gik, T., et al.[2021]

A Mediterranean diet supplemented with dairy foods significantly reduced systolic and diastolic blood pressure in participants at risk of cardiovascular disease, indicating improved cardiovascular health.

The MedDairy diet also led to favorable changes in cholesterol levels, including higher HDL cholesterol and lower triglycerides, suggesting it may be an effective dietary approach for managing cardiovascular risk factors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Mediterranean diet supplemented with dairy foods improves markers of cardiovascular risk: results from the MedDairy randomized controlled trial. Wade, AT., Davis, CR., Dyer, KA., et al.[2023]

In a study of 80 Italian patients with inflammatory bowel disease (IBD), adherence to the Mediterranean diet (MD) was found to be significantly higher in patients with Crohn's Disease who were in an inactive disease phase, suggesting that disease activity impacts dietary adherence.

The study indicated that better adherence to the Mediterranean diet could potentially improve quality of life and modulate disease activity in IBD patients, highlighting the importance of nutritional education in managing the condition.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adherence to mediterranean diet in patients with inflammatory bowel disease. Fiorindi, C., Dinu, M., Gavazzi, E., et al.[2022]

Citations

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The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure.

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