Study of Dietary Composition in Crohn's Disease (CD)

University of California, Los Angeles (UCLA)

Status: Terminated

Conditions: Inflammatory Bowel Diseases; Crohn Disease

Treatments: Other: Regular diet; Other: Anti-inflammatory diet

Study type: Interventional

Funder types: Other

Identifiers

NCT04431700

20-001120

Details and patient eligibility

About

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.

Full description

A randomized controlled trial of the anti-inflammatory whole food diet versus usual diet for the induction of remission in 104 adults with mild-to-moderate Crohn's Disease (CD). The anti-inflammatory whole food diet will be compared to participants usual diet for understanding its effects on achieving clinical remission, clinical response, reduction in serological and fecal markers of inflammation, and improvement in patient-reported outcomes, such as physical activity, anxiety, depression, fatigue, pain, sleep disturbance, social satisfaction, and quality of life. The study will involve collection of blood and fecal specimens to evaluate the effects of the anti-inflammatory diet on the gut microbiome, bacterial metabolome, innate immune markers, and fecal microRNA profiles. The participants will be placed on anti-inflammatory diet for 8 weeks and assessed every 2 weeks for adherence.

Enrollment: 28 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age of 18 to 75 years old
• History of Crohn's Disease (CD) with mild to moderate symptoms and prior biopsy proof

Exclusion criteria

1. History or current diagnosis of any of the following:

   • Stroke or Arrhythmia
   • Seizures
   • Liver Disease
   • Untreated hypertension (High Blood Pressure)
   • Active malignancy
   • Bleeding disorders
   • Heart Disease
   • Lung disease
   • Previous Heart surgery
   • Previous Gastrointestinal Surgery
   • Kidney Disease
   • Chronic Diarrhea
   • End enterostomy
   • Bulimia
   • Anorexia
   • Laxative Abuse
   • Endocrine Disorder
   • Current history of smoking tobacco
   • Urgent need for abdominal sugery
   • Severe Malnutrition
   • Active alcohol or non-cannabinoid substance abuse

2. Recent hospitalization within the last 30 days

3. Currently pregnant of lactating.

4. Current use probiotics or dietary supplements that would not be willing to discontinue for the length of the study.

5. Concerns for non-compliance

6. If currently on immunosuppressants, immunomodulators, cotticosteroids, and/or 5-aminosalicylates, no changes in doses will be permitted during the trial except for tapering of corticosteroids.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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28 participants in 2 patient groups

Anti-inflammatory whole food

Experimental group

Description:

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.

Treatment:

Other: Anti-inflammatory diet

Regular Diet

Active Comparator group

Description:

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

Treatment:

Other: Regular diet