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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
History or current diagnosis of any of the following:
Recent hospitalization within the last 30 days
Currently pregnant of lactating.
Current use probiotics or dietary supplements that would not be willing to discontinue for the length of the study.
Concerns for non-compliance
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.
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| Name | Affiliation | Role |
|---|---|---|
| Zhaoping Li, MD, PhD | University of California, Los Angeles | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UCLA Center for Human Nutrition, 1000 Veteran Ave. | Los Angeles | California | 90095 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40818622 | Derived | 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. |
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| ID | Term |
|---|---|
| D015212 | Inflammatory Bowel Diseases |
| D003424 | Crohn Disease |
| ID | Term |
|---|---|
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D007410 | Intestinal Diseases |
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| ID | Term |
|---|---|
| D004032 | Diet |
| ID | Term |
|---|---|
| D009747 | Nutritional Physiological Phenomena |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
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This is a randomized, single-blind, controlled trial. All eligible participants will be randomly assigned to one of two diets.
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| Regular diet | Other | Focus on food journal and recording all food intake. |
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