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

• ClinicalTrials.gov Identifier: NCT04431700
• Recruitment Status: Recruiting
• First Posted: June 16, 2020
• Last Update Posted: November 11, 2021
• Sponsor: University of California, Los Angeles
• Information provided by (Responsible Party): Zhaoping Li, University of California, Los Angeles

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Inflammatory Bowel Diseases; Crohn Disease	Other: Anti-inflammatory diet; Other: Regular diet	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 116 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: This is a randomized, single-blind, controlled trial. All eligible participants will be randomly assigned to one of two diets.
• Masking: None (Open Label)
• Primary Purpose: Prevention
• Official Title: Impact of Anti-Inflammatory Whole-Food Diet in Crohn's Disease and Predicting Response to Therapy
• Actual Study Start Date: October 5, 2020
• Estimated Primary Completion Date: January 31, 2023
• Estimated Study Completion Date: May 1, 2023

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures :

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

Eligibility Criteria

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

Criteria

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.

Contacts and Locations

Contacts

Contact: Gail Thames; 310-825-0453; Gthames@mednet.ucla.edu

Contact: Dina Ben-Nissan; 310-206-2582; Dbennissan@mednet.ucla.edu

Locations

United States, California

UCLA Center for Human Nutrition, 1000 Veteran Ave.; Recruiting

Los Angeles, California, United States, 90095

Contact: Gail Thames 310-825-0453 gthames@mednet.ucla.edu

Contact: Dina Ben-Nissan 310-206-2582 dbennissan@mednet.ucla.edu

Principal Investigator: Zhaoping Li

Sponsors and Collaborators

University of California, Los Angeles

Investigators

• Principal Investigator: Zhaoping Li, MD, PhD; University of California, Los Angeles

More Information

• Responsible Party: Zhaoping Li, Principal Investigator, University of California, Los Angeles
• ClinicalTrials.gov Identifier: NCT04431700
• Other Study ID Numbers: 20-001120
• First Posted: June 16, 2020
• Last Update Posted: November 11, 2021
• Last Verified: November 2021

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Zhaoping Li, University of California, Los Angeles:

Crohn's Disease; IBD; Anti-inflammatory Diet

Additional relevant MeSH terms:

Crohn Disease; Inflammatory Bowel Diseases; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases; Anti-Inflammatory Agents