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| ID | Type | Description | Link |
|---|---|---|---|
| CDMRP-PR251962 | Other Grant/Funding Number | Defense Health Agency |
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| Name | Class |
|---|---|
| United States Department of Defense | FED |
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The purpose of this study is to test the effect of an anti-inflammatory diet tailored for patients living in the United States with Crohn's Disease (CD) on clinical symptoms and disease inflammation and to identify biomarkers of response to dietary therapy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sequence A→B: Catered Anti-Inflammatory Diet Followed by Diet Guidance Group | Experimental | Participants in this group will first receive an 8-week catered anti-inflammatory diet intervention, followed by a 2-week washout period, then an 8-week diet guidance period in which they consume their usual diet with weekly counseling focused on safe food preparation. |
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| Sequence B→A: Diet Guidance Followed by Catered Anti-Inflammatory Diet Group | Experimental | Participants in this group will first receive an 8-week diet guidance period with weekly counseling while consuming their usual diet, followed by a 2-week washout period, then an 8-week catered anti-inflammatory diet intervention. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Catered Anti-Inflammatory Diet | Behavioral | Participants will receive a fully catered anti-inflammatory diet for 8 weeks, with meals delivered twice weekly. The diet is designed to provide >25 g fiber/day, a <3:1 n-6:n-3 fatty acid ratio, and <30% of total calories from fat, and excludes red meat, processed meats, fried foods, emulsifiers, artificial sweeteners, food colorings, and other ultra-processed ingredients. Participants will also receive weekly remote sessions with a registered dietitian focused on dietary adherence, meal customization, grocery shopping, food affordability, and basic cooking skills. |
| Measure | Description | Time Frame |
|---|---|---|
| Participants Achieving Crohn's Disease Activity Index (CDAI) Clinical Response | Clinical response is defined as a ≥70-point reduction from baseline in the Crohn's Disease Activity Index (CDAI). The outcome is the percentage of participants who achieve this response following the dietary intervention. | Baseline, Week 8, Week 10, Week 18 |
| Participants Achieving Fecal Calprotectin (FC) Reduction | Reduction is defined as a >50% decrease from baseline in fecal calprotectin (FC). The outcome is the percentage of participants who achieve this reduction. | Baseline, Week 8, Week 10, Week 18 |
| Measure | Description | Time Frame |
|---|---|---|
| Participants Achieving Crohn's Disease Activity Index (CDAI) Clinical Remission | Clinical Remission is defined as achieving a Crohn's Disease Activity Index (CDAI) score of <150. The outcome is the percentage of participants who achieve this score. | Baseline, Week 8, Week 10, Week 18 |
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Inclusion Criteria:
Crohn's disease activity index (CDAI) 150-250 (mild-to-moderate only active disease) AND presence of active inflammation either by: fecal calprotectin >150mg/dl. or radiologic findings of active ileal and/or colonic disease, or endoscopic findings showing active ileal and/or colonic disease within 4 weeks of baseline
-On stable medications for their disease as or 3 months if medication is not listed
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Eytan I Stern, MS, RD, LD/N, CNSC | Contact | 305-243-6405 | eis43@miami.edu |
| Name | Affiliation | Role |
|---|---|---|
| Oriana M Damas, MD, MSCTI | University of Miami | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Miami | Miami | Florida | 33136 | United States |
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| ID | Term |
|---|---|
| D003424 | Crohn Disease |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D015212 | Inflammatory Bowel Diseases |
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
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| Diet Guidance for Usual Diet | Behavioral | Participants will continue consuming their self-selected usual diet for 8 weeks. During this period, participants will receive weekly remote sessions with a registered dietitian focused on safe food handling, food preparation and cooking practices, and general nutrition education. Participants will also receive grocery gift cards to support food purchasing and to maintain equivalent contact time and participant engagement across study periods. No specific dietary pattern, food restrictions, or nutrient intake targets will be prescribed during this phase. |
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| D007410 | Intestinal Diseases |
| D001519 | Behavior |