An interventional study of Anti-inflammatory diet and Regular diet in Inflammatory Bowel Diseases and Crohn Disease, sponsored by University of California, Los Angeles. Terminated at 1 site in United States. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2025-12-18.
Sponsored by University of California, Los Angeles · Not applicable, Interventional, and Prevention
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.
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.
1,460 studies on the registry are indexed under Inflammatory Bowel Diseases; 437 are open to participants now.
This study's enrollment of 28 is below the median of 70 across 770 interventional studies indexed under Inflammatory Bowel Diseases.
Browse Inflammatory Bowel Diseases studies →University of California, Los Angeles is the lead sponsor of 1,142 studies on the registry; 192 are open to participants now.
Of its 91 completed or terminated interventional studies of FDA-regulated products, 66 (73%) have results posted.
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Exclusion Criteria:
History or current diagnosis of any of the following:
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
Patients in the control diet arm will be counseled to continue their regular diets and focus on recording all food intake.
Other: Regular 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.
Focus on food journal and recording all food intake.
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.
Time frame: 8 weeks
Plan to share: No
This study is terminated, as verified in Dec 2025. You cannot join it, but the record below documents what was studied.
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University of California, Los Angeles