Anti-inflammatory Diet for Crohn's Disease

(CD Trial)

Recruiting in Palo Alto (17 mi)

Overseen by Zhaoping Li, MD, PhD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: University of California, Los Angeles

Must not be taking: Probiotics, Dietary supplements

Disqualifiers: Stroke, Heart disease, Liver disease, others

No Placebo Group

Approved in 1 Jurisdiction

Trial Summary

What is the purpose of this trial?

Patients with inflammatory bowel disease (IBD) often have narrowed microbial diversity and altered composition and function of the gut microbiome. We anticipate the anti-inflammatory diet, when compared with the usual diet, to produce favorable changes in these multi-omics profiles. These findings will provide insight into the interactions between diet and host biology, while providing clues on the mechanisms of diet therapy's effect and CD pathogenesis.

Will I have to stop taking my current medications?

The trial requires that if you are currently taking immunosuppressants, immunomodulators, corticosteroids, or 5-aminosalicylates, you must keep the same doses during the study, except for corticosteroids, which can be tapered off. You must also stop using probiotics or dietary supplements for the length of the study.

What data supports the effectiveness of the treatment Anti-inflammatory diet for Crohn's Disease?

Research shows that the Mediterranean diet, which is part of the anti-inflammatory diet, can help reduce inflammation and improve symptoms in people with Crohn's disease. Studies have found that this diet improves clinical scores and inflammatory markers, suggesting it can be beneficial for managing the condition.

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Is the anti-inflammatory or Mediterranean diet safe for humans?

The Mediterranean diet, which is similar to an anti-inflammatory diet, has been studied for safety and is generally considered safe for humans, including children and adolescents with inflammatory bowel disease.

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How is the anti-inflammatory diet treatment for Crohn's disease different from other treatments?

The anti-inflammatory diet, specifically the Mediterranean diet, is unique because it focuses on reducing inflammation through dietary changes, such as increasing antioxidants and modifying dietary fats, rather than using medication. This approach can improve disease activity and inflammatory markers in Crohn's disease patients by altering gut microbiota and reducing chronic inflammation.

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Eligibility Criteria

This trial is for adults aged 18-75 with mild to moderate Crohn's Disease, confirmed by a previous biopsy. Participants should not have severe other conditions like heart or liver disease, recent hospitalizations, substance abuse issues, or be pregnant. They must be willing to stop taking probiotics and certain medications without changing their dosage during the study.

Inclusion Criteria

I have mild to moderate Crohn's Disease confirmed by a biopsy.

I am between 18 and 75 years old.

Exclusion Criteria

Current history of smoking tobacco

I have been diagnosed with or have a history of anorexia.

I have had surgery on my digestive system in the past.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants are placed on an anti-inflammatory whole food diet for 8 weeks and assessed every 2 weeks for adherence

8 weeks

4 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Participant Groups

The study compares the effects of an anti-inflammatory diet versus a regular diet on patients with Crohn's Disease. It aims to see if the special diet can positively change gut bacteria diversity and function, which could provide insights into how diet affects this condition.

Group I: Anti-inflammatory whole food Experimental Treatment 1 Intervention

Included food items will include a defined minimum diversity of fruits, vegetables, and nuts based on complementary phytonutrient contents, particularly those rich in phenolic compounds such as ellagitannins and sulforaphanes. Selected herbs (e.g., curcumin), fermented foods, fats (e.g., avocado), and oils (e.g., olive oil) will be permitted or encouraged. Recommended portions of complex carbohydrates (50% - 60%) and lean proteins (20% - 30%) will form the basis of weight-based caloric needs. The goal is to have 5 servings of vegetables, 2 fruits per day, and 5 vegetable color groups per week. Vegetables with high insoluble fiber content will be cooked instead of eaten raw.

Group II: Regular Diet Active Control 1 Intervention

Patients in the control diet arm will be counseled to continue their regular diets and focus on recording all food intake.

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

UCLA Center for Human Nutrition, 1000 Veteran Ave. Los Angeles, CA

Who Is Running the Clinical Trial?

University of California, Los Angeles Lead Sponsor

References

1. England pubmed.ncbi.nlm.nih.gov

Mediterranean diet diminishes the effects of Crohn's disease and improves its parameters: A systematic review. [2022] The pathogenesis and clinical course of Crohn's disease (CD) is influenced by diet. Mediterranean Diet (MD) helps Crohn's patients through many mechanisms.

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

Transcriptomics to study the effect of a Mediterranean-inspired diet on inflammation in Crohn's disease patients. [2021] Inflammation is an essential immune response; however, chronic inflammation results in disease including Crohn's disease. Therefore, reducing the inflammation can yield a significant health benefit, and one way to achieve this is through diet. We developed a Mediterranean-inspired anti-inflammatory diet and used this diet in a 6-week intervention in a Crohn's disease population. We examined changes in inflammation and also in the gut microbiota. We compared the results of established biomarkers, C-reactive protein and the micronuclei assay, of inflammation with results from a transcriptomic approach.

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] The Mediterranean diet (MD) is a well-known style of diet that is full of antioxidants and may have anti-inflammatory effects. We evaluated the safety, tolerability, and effects of adherence to MD on disease activity and inflammatory markers in children and adolescents with active inflammatory bowel disease (IBD).

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

Dietary Habit Modifications in Paediatric Patients after One Year of Treatment with the Crohn's Disease Exclusion Diet. [2023] Gut microbiota alterations play a key role in the pathogenesis of inflammatory bowel disease (IBD), and its modification through specific diets is an emerging line of treatment that is currently being researched. The aim of this study was to assess changes in the dietary habits of patients with Crohn's disease (CD) and their long-term adherence to dietary therapy with the Crohn's disease exclusion diet (CDED) after one year. To analyse the modification of dietary habits and adherence to the Mediterranean diet (DM), the KIDMED questionnaire, a food consumption frequency questionnaire, was used. Twenty-four hour recalls at two timepoints, namely prior to the start of the dietary therapy and one year later, were also carried out. The processing degrees of the foods consumed by the patients were analysed at both timepoints using the NOVA classification system. Data from 24 patients (15 boys), with a mean age of 12.7 ± 2.9 years at the start of the dietary therapy, were analysed. All patients showed an improvement in their dietary pattern in the form of a reduction in the intake of ultra-processed foods (UPFs); a higher adherence to the MD; a decrease in the intake of cold meats, seafood, pasta, precooked foods, soft drinks, and pastries; an increase in the intake of eggs, legumes, dairy products, and nuts (p < 0.05); and adequate adherence, even in the long-term, to foods allowed during the different phases of the dietary regimen. Although more factors have an impact on the course of the disease in these patients, improving their dietary habits is essential.

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

A Randomized Trial Comparing the Specific Carbohydrate Diet to a Mediterranean Diet in Adults With Crohn's Disease. [2022] This study compared the effectiveness of the Specific Carbohydrate Diet (SCD) to the Mediterranean diet (MD) as treatment for Crohn's disease (CD) with mild to moderate symptoms.

6. England pubmed.ncbi.nlm.nih.gov

Adherence to mediterranean diet in patients with inflammatory bowel disease. [2022] Mediterranean diet may be beneficial for inflammatory bowel disease (IBD). The aim of this study was to evaluate the level of adherence to MD in Italian patients with IBD.

7. England pubmed.ncbi.nlm.nih.gov

An anti-inflammatory diet as treatment for inflammatory bowel disease: a case series report. [2022] The Anti-Inflammatory Diet (IBD-AID) is a nutritional regimen for inflammatory bowel disease (IBD) that restricts the intake of certain carbohydrates, includes the ingestion of pre- and probiotic foods, and modifies dietary fatty acids to demonstrate the potential of an adjunct dietary therapy for the treatment of IBD.

8. 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] Mediterranean diet (MED) is associated with health benefits, yet scarce data exist regarding the role of MED in inflammatory bowel diseases (IBD). Herein, we aimed to evaluate the association between MED and inflammatory markers in patients with IBD after pouch surgery.