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

Trial Summary

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 data supports the effectiveness of the Mediterranean Diet as a treatment for Inflammatory Bowel Disease?

Research suggests that following a Mediterranean Diet, which is rich in antioxidants and has anti-inflammatory effects, can improve disease activity and reduce inflammation in patients with Inflammatory Bowel Disease, including children and those with ulcerative colitis. ^{1 2 3 4 5}

Is the Mediterranean Diet safe for people with inflammatory bowel disease?

The Mediterranean Diet is generally considered safe for people, including those with inflammatory bowel disease, as it is rich in antioxidants and has anti-inflammatory effects. Studies have evaluated its safety and tolerability, showing it can improve health markers without significant safety concerns. ^{1 2 3 5 6}

How does the Mediterranean Diet treatment differ from other treatments for inflammatory bowel disease?

The Mediterranean Diet is unique because it focuses on a high intake of plant foods, olive oil, and low amounts of dairy and meat, which may help reduce inflammation and improve gut health by enriching beneficial bacteria. Unlike standard drug treatments, it is a dietary approach that can be adjusted based on individual tolerance, potentially offering a natural way to manage symptoms. ^{1 2 3 4 7}

What is the purpose of this trial?

The effects of diet on inflammatory bowel disease is an under-studied area of research. The investigators are interested in further investigating the role that diet contributes to inflammatory bowel disease severity. The investigators will collect blood and stool samples from patients with inflammatory bowel disease (IBD) before and after diet changes. The stool samples will be analyzed using metabolomics and microbiome analysis to determine changes after the new diet has been implemented. The investigators will then compare changes in the patient's overall disease state by measuring markers of inflammation including C-reactive protein (CRP) and fecal calprotectin to determine how this diet affects the disease state.

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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 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]

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 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]

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]

References

1. Turkey pubmed.ncbi.nlm.nih.gov

The Effect of Adherence to Mediterranean Diet on Disease Activity in Patients with Inflammatory Bowel Disease. [2023]

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

Adherence to mediterranean diet in patients with inflammatory bowel disease. [2022]

3. New Zealand 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. [2022]

4. Switzerland pubmed.ncbi.nlm.nih.gov

Dietary adherence to the Mediterranean diet pattern in a randomized clinical trial of patients with quiescent ulcerative colitis. [2023]

5. Germany pubmed.ncbi.nlm.nih.gov

Adherence to the Mediterranean diet is associated with decreased fecal calprotectin in patients with ulcerative colitis after pouch surgery. [2021]

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

A Mediterranean diet supplemented with dairy foods improves markers of cardiovascular risk: results from the MedDairy randomized controlled trial. [2023]

7. Switzerland pubmed.ncbi.nlm.nih.gov

Should the Mediterranean diet be recommended for inflammatory bowel diseases patients? A narrative review. [2023]