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

Impact of Anti-Inflammatory Whole-Food Diet in Crohn's Disease and Predicting Response to Therapy

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.

Study Overview

• Status: Recruiting
• Conditions: Inflammatory Bowel Diseases; Crohn Disease
• Intervention / Treatment: Other: Anti-inflammatory diet; Other: Regular diet

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 Type: Interventional
• Enrollment (Anticipated): 116
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Dina Ben-Nissan; Phone Number: 310-206-2582; Email: dbennissan@mednet.ucla.edu

Study Locations

• United States
  • California
    • Los Angeles, California, United States, 90095
      • Recruiting
      • UCLA Center for Human Nutrition, 1000 Veteran Ave.
      • Contact: Dina Ben-Nissan; Phone Number: 310-206-2582; Email: dbennissan@mednet.ucla.edu
      • Principal Investigator: Zhaoping Li

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Anti-inflammatory whole food; 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.	Other: Anti-inflammatory diet; Anti-inflammatory diet with increased vegetables, fruit, plant polyphenols, lean proteins, foods rich in omega-3s and unsaturated fats as well as decreased in processed refined foods.
Active Comparator: Regular Diet; Patients in the control diet arm will be counseled to continue their regular diets and focus on recording all food intake.	Other: Regular diet; Focus on food journal and recording all food intake.

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: University of California, Los Angeles

Study record dates

Study Major Dates

• Study Start (Actual): October 5, 2020
• Primary Completion (Anticipated): January 31, 2025
• Study Completion (Anticipated): May 1, 2025

Study Registration Dates

• First Submitted: June 4, 2020
• First Submitted That Met QC Criteria: June 11, 2020
• First Posted (Actual): June 16, 2020

Study Record Updates

• Last Update Posted (Estimate): May 5, 2023
• Last Update Submitted That Met QC Criteria: May 4, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Keywords: IBD; Crohn's Disease; Anti-inflammatory Diet
• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Gastroenteritis; Intestinal Diseases; Inflammatory Bowel Diseases; Crohn Disease; Anti-Inflammatory Agents
• Other Study ID Numbers: 20-001120

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No