116 Participants Needed

Anti-inflammatory Diet for Crohn's Disease

(CD Trial)

GT
DB
Overseen ByDina Ben-Nissan
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: University of California, Los Angeles
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Approved in 1 JurisdictionThis treatment is already approved in other countries

What You Need to Know Before You Apply

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.

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.12345

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.12346

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.12678

Who Is on the Research Team?

ZL

Zhaoping Li, MD, PhD

Principal Investigator

University of California, Los Angeles

Are You a Good Fit for This Trial?

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.

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.
See 23 more

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

  • Anti-inflammatory diet
  • Regular diet
Trial Overview 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.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Active Control
Group I: Anti-inflammatory whole foodExperimental Treatment1 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 DietActive Control1 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

Who Is Running the Clinical Trial?

University of California, Los Angeles

Lead Sponsor

Trials
1,594
Recruited
10,430,000+

Published Research Related to This Trial

A systematic review of five studies involving 83,564 participants found that adherence to the Mediterranean Diet (MD) is associated with reduced disease activity in Crohn's disease (CD) patients, indicating its potential anti-inflammatory effects.
Patients with inactive CD who followed the MD showed significant improvements, including a 70-point reduction in Crohn's Disease Activity Index (CDAI) and lower levels of inflammatory markers, suggesting that the MD may help manage symptoms and reduce the risk of future disease development.
Mediterranean diet diminishes the effects of Crohn's disease and improves its parameters: A systematic review.Jaber, M., Altamimi, M., Altamimi, A., et al.[2022]
A 6-week Mediterranean-inspired anti-inflammatory diet significantly reduced established biomarkers of inflammation in participants with Crohn's disease, indicating its potential as a dietary intervention.
Transcriptomic analysis revealed substantial changes in gene expression, suggesting that the diet may have a broader impact on health beyond what traditional biomarkers can measure.
Transcriptomics to study the effect of a Mediterranean-inspired diet on inflammation in Crohn's disease patients.Marlow, G., Ellett, S., Ferguson, IR., et al.[2021]
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]

Citations

Mediterranean diet diminishes the effects of Crohn's disease and improves its parameters: A systematic review. [2022]
Transcriptomics to study the effect of a Mediterranean-inspired diet on inflammation in Crohn's disease patients. [2021]
Adherence to the Mediterranean Diet Improved Clinical Scores and Inflammatory Markers in Children with Active Inflammatory Bowel Disease: A Randomized Trial. [2022]
Dietary Habit Modifications in Paediatric Patients after One Year of Treatment with the Crohn's Disease Exclusion Diet. [2023]
A Randomized Trial Comparing the Specific Carbohydrate Diet to a Mediterranean Diet in Adults With Crohn's Disease. [2022]
Adherence to mediterranean diet in patients with inflammatory bowel disease. [2022]
An anti-inflammatory diet as treatment for inflammatory bowel disease: a case series report. [2022]
Adherence to the Mediterranean diet is associated with decreased fecal calprotectin in patients with ulcerative colitis after pouch surgery. [2021]
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