Study of Dietary Composition in Crohn's Disease

Not Applicable

Recruiting

• Conditions: Inflammatory Bowel Diseases; Crohn Disease
• Interventions: Other: Anti-inflammatory diet; Other: Regular diet

• Registration Number: NCT04431700
• Lead Sponsor: University of California, Los Angeles

Brief Summary

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.

Detailed 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.

Study Timeline

• Study First Submitted: 2020-06-04
• Study First Submitted QC: 2020-06-11
• Study First Posted: 2020-06-16
• Study Start: 2020-10-05
• Status Verified: 2023-05
• Last Update Submitted: 2023-05-04
• Last Update Posted: 2023-05-06
• Primary Completion: 2025-01-31
• Study Completion: 2025-05-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 116

Inclusion Criteria

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

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Anti-inflammatory whole food	Anti-inflammatory diet	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.
Regular Diet	Regular diet	Patients in the control diet arm will be counseled to continue their regular diets and focus on recording all food intake.

Primary Outcome Measures

Name	Time	Method
Efficacy of the anti-inflammatory whole food diet for the induction of remission in Crohn's Disease	8 weeks	The patients' clinical response, defined by the Harvey-Bradshaw Index (HBI) (5 through 16 points) for clinical symptom improvement and/or remission.

Trial Locations

Locations (1)

UCLA Center for Human Nutrition, 1000 Veteran Ave.; 🇺🇸 Los Angeles, California, United States