Study of Dietary Composition in Crohn's Disease

NCT04431700 | Terminated

• 1 other identifier: 20-001120
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

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.

Conditions

Inflammatory Bowel Diseases; Crohn Disease

Keywords

Crohn's Disease; IBD; Anti-inflammatory Diet

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Anti-inflammatory whole food

EXPERIMENTAL

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

Regular Diet

ACTIVE COMPARATOR

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

Other: Regular diet

Interventions

Anti-inflammatory diet OTHER

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.

Anti-inflammatory whole food

Regular diet OTHER

Focus on food journal and recording all food intake.

Regular Diet

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of California, Los Angeles: lead

Study Sites (1)

UCLA Center for Human Nutrition, 1000 Veteran Ave.

Los Angeles, California, 90095, United States

Location

Related Publications (1)

• Limketkai BN, Yang J, Chau L, Noorian S, Li Z. Randomized controlled trial of a natural whole food diet versus habitual diet for Crohn's disease: Is diet quality the key? Clin Nutr ESPEN. 2025 Oct;69:580-589. doi: 10.1016/j.clnesp.2025.08.015. Epub 2025 Aug 14.

  PMID: 40818622 DERIVED

MeSH Terms

Conditions

Inflammatory Bowel Diseases; Crohn Disease

Interventions

Diet

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Intervention Hierarchy (Ancestors)

Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Study Officials

• Zhaoping Li, MD, PhD

  University of California, Los Angeles

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: This is a randomized, single-blind, controlled trial. All eligible participants will be randomly assigned to one of two diets.

Study Record Dates

• First Submitted: June 4, 2020
• First Posted: June 16, 2020
• Study Start: October 5, 2020
• Primary Completion: March 31, 2025
• Study Completion: March 31, 2025
• Last Updated: December 18, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)