Anti-inflammatory Diet for Crohn's Disease

(CD Trial)

Overseen By Dina Ben-Nissan

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of California, Los Angeles

Must not be taking: Probiotics, Dietary supplements

Disqualifiers: Stroke, Heart disease, Liver disease, others

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

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 4

Duration: 8 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how an anti-inflammatory diet may benefit people with Crohn's Disease, a condition that causes digestive tract inflammation. Researchers aim to determine if dietary changes can improve gut health and reduce symptoms compared to a regular diet. Participants will either follow a special diet rich in fruits, vegetables, nuts, and certain herbs or continue their usual eating habits. This trial may suit those with Crohn's Disease who have mild to moderate symptoms and a biopsy-confirmed diagnosis. As an unphased trial, it offers a unique opportunity to contribute to understanding dietary impacts on Crohn's Disease.

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 there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that an anti-inflammatory diet can safely help manage Crohn's disease. Studies have found that dietary changes can reduce inflammation and improve gut health. For example, one study found that diets like the Mediterranean diet, rich in fruits, vegetables, nuts, and healthy oils, can lead to better outcomes for people with Crohn's disease.

This diet emphasizes consuming beneficial foods such as fruits, vegetables, and whole grains while avoiding foods that may cause inflammation. People generally find this diet easy to follow, and it lacks the side effects that some medications might have.

Overall, while more research is ongoing, current evidence suggests that an anti-inflammatory diet is a safe choice for managing Crohn's disease symptoms. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike the standard of care for Crohn's Disease, which typically includes medications like anti-inflammatory drugs, immune system suppressors, and biologics, the treatment under study here is an anti-inflammatory diet. This diet is unique because it emphasizes a diverse intake of whole foods rich in phytonutrients, such as fruits, vegetables, nuts, and certain herbs like curcumin. Researchers are excited about this approach because it targets inflammation naturally and holistically, potentially reducing reliance on pharmaceutical interventions. By focusing on foods high in phenolic compounds like ellagitannins and sulforaphanes, this diet might offer a more sustainable and gentle way to manage symptoms and improve gut health.

What evidence suggests that the anti-inflammatory diet might be an effective treatment for Crohn's Disease?

Research has shown that anti-inflammatory diets, such as the Mediterranean diet, can benefit people with Crohn's disease. These diets are linked to reduced gut swelling and better disease control. In this trial, participants will either follow an anti-inflammatory whole food diet or continue their regular diet. One study found that an anti-inflammatory diet can improve the quality of life for those with Crohn's. Another study noted that these diets can lower inflammation markers in the body, such as C-reactive protein. Overall, evidence suggests that an anti-inflammatory diet can effectively manage Crohn's disease. ^{6 7 8 9 10}

Who Is on the Research Team?

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.

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?

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.

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

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]

A study involving 24 patients with Crohn's disease showed significant improvements in dietary habits after one year of following the Crohn's disease exclusion diet (CDED), including reduced intake of ultra-processed foods and increased consumption of healthier options like eggs, legumes, and nuts.

Patients demonstrated long-term adherence to the Mediterranean diet, indicating that dietary modifications can play a crucial role in managing Crohn's disease, although other factors also influence disease progression.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dietary Habit Modifications in Paediatric Patients after One Year of Treatment with the Crohn's Disease Exclusion Diet. Martín-Masot, R., Herrador-López, M., Navas-López, VM.[2023]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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]

In a study of 194 patients with mild to moderate Crohn's disease, the Specific Carbohydrate Diet (SCD) did not show superior effectiveness compared to the Mediterranean Diet (MD) in achieving symptomatic remission after 6 weeks, with remission rates of 46.5% for SCD and 43.5% for MD (P = .77).

Both diets resulted in low rates of fecal calprotectin (FC) and C-reactive protein (CRP) responses, indicating limited effectiveness in reducing inflammation, and given the ease of following the MD and its additional health benefits, it may be the preferred option for patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Randomized Trial Comparing the Specific Carbohydrate Diet to a Mediterranean Diet in Adults With Crohn's Disease. Lewis, JD., Sandler, RS., Brotherton, C., et al.[2022]

In a study of 40 patients with inflammatory bowel disease (IBD), 60% of those who followed the Anti-Inflammatory Diet (IBD-AID) reported good or very good responses, with all patients experiencing symptom reduction and the ability to discontinue at least one medication.

Among 11 patients reviewed in detail, significant improvements were observed in disease severity scores, with the Harvey Bradshaw Index decreasing from a mean of 11 to 1.5 and the Modified Truelove and Witts Severity Index dropping from 7 to 0 after following the diet for at least 4 weeks.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An anti-inflammatory diet as treatment for inflammatory bowel disease: a case series report. Olendzki, BC., Silverstein, TD., Persuitte, GM., et al.[2022]

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 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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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.

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]

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