NCT04431700

Study of Dietary Composition in Crohn's Disease

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

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 28 (actual)
• Sponsor: University of California, Los Angeles · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
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.
OTHER	Regular diet	Focus on food journal and recording all food intake.

Timeline

• Start date: 2020-10-05
• Primary completion: 2025-03-31
• Completion: 2025-03-31
• First posted: 2020-06-16
• Last updated: 2025-12-18

Locations

1 site across 1 country: United States