90 Participants Needed

Mediterranean Diet for Inflammatory Bowel Disease

MG
MA
Overseen ByMehrnaz Aghili, M.D.
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: University of California, San Diego
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

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.12345

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.678910

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
See 6 more

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?
1Treatment groups
Experimental Treatment
Group I: Mediterranean DietExperimental Treatment1 Intervention

Find a Clinic Near You

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.
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.
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.
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]

Citations

Should the Mediterranean diet be recommended for ...The data suggest, MD affect gut microbiota positively, decreasing risk of IBD (51). Mediterranean-like dietary pattern reduces intestinal inflammation among ...
S1916 The Mediterranean Diet and Inflammatory Bowel...The MD was associated with a statistically significant improvement in clinical remission compared to NMD (RR 1.18, P = 0.02). When compared specifically to a ...
The Effect of Adherence to Mediterranean Diet on Disease ...Stronger adherence to the Mediterranean diet in patients with ulcerative colitis can help improve quality of life and modulate disease activity.
A Mediterranean Diet Pattern Improves Intestinal Inflammation ...The MDP reduces clinical symptoms and reduces inflammation. A total of 96% [27/28] of participants entered the study in remission [PMS of 0], ...
Diet, Food, and Nutritional Exposures and Inflammatory ...Several dietary patterns have been associated with clinical remission of IBD, including Mediterranean diets [8,27,51], a specific carbohydrate diet low in ...
Mechanistic Implications of the Mediterranean Diet in ...Clinical Research Relevance. This study associates the Mediterranean diet with beneficial clinical outcomes in patients with Crohn's disease.
Mediterranean Diet Adherence and Dietary Attitudes in ...Overall, the MD is considered to have a high potential to modulate gut inflammation and to be a therapeutic and preventive tool for IBD [25,26].
Association between adherence to Mediterranean-DASH ...The results indicated that the patients in the higher tertile of the MIND diet score had 61% lower odds of having severe UC than those in the ...
Effect of Mediterranean Diet in Inflammatory Bowel DiseaseThe 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.
From Evidence to Practice: A Narrative Framework for ...Collectively, these studies highlight the potential of the MD to improve clinical outcomes and enhance quality of life in patients with IBD, with minimal ...
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