Study of Dietary Composition in Crohn's Disease

NCT ID: NCT04431700

Last Updated: 2025-12-18

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 28 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-10-05
• Study Completion Date: 2025-03-31

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.

Conditions

Inflammatory Bowel Diseases; Crohn Disease

Keywords

Crohn's Disease; IBD; Anti-inflammatory Diet

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Anti-inflammatory diet

Intervention Type: 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.

Regular Diet

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

Group Type: ACTIVE_COMPARATOR

Regular diet

Intervention Type: OTHER

Focus on food journal and recording all food intake.

Interventions

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.

Intervention Type: OTHER

Regular diet

Focus on food journal and recording all food intake.

Intervention Type: OTHER

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of California, Los Angeles

OTHER

Sponsor Role: lead

Responsible Party

Zhaoping Li

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Zhaoping Li, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University of California, Los Angeles

Locations

UCLA Center for Human Nutrition, 1000 Veteran Ave.

Los Angeles, California, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 40818622 (View on PubMed)

Other Identifiers

20-001120

Identifier Type: -

Identifier Source: org_study_id