Crohn's Disease, Active, Crohn's Disease (CD), Diet Interventions
Conditions
Brief summary
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.
Interventions
BEHAVIORALCatered Anti-Inflammatory Diet
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.
BEHAVIORALDiet Guidance for Usual Diet
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.
Sponsors
University of Miami
United States Department of Defense
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
16 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Documented diagnosis with Crohn's Disease from medical records. * Ages 16-75 * Mild to moderately active CD disease, defined by one of the following 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
* Diagnosis of Ulcerative Colitis (UC). * Prior J pouch or diversion * Recent inflammatory bowel disease (IBD) related hospitalizations in the last 4 weeks * Clostridium difficile or enteric infections in the last 4 weeks * Use of probiotics in the last 4 weeks * Patients following the specific carbohydrate diet or Mediterranean diet or anti-inflammatory diet * Active cancer or conditions limiting their ability to follow a diet (heart failure, end stage renal disease) * Pregnancy, breastfeeding or planning to become pregnant during study period * Use of Total Parenteral Nutrition at the time of screening and during the study period * Other significant or life-threatening co-morbidities * The need for antibiotic use during the study period * Adults unable to consent * Ages \< 16 and \> 75 years old * Prisoners * Crohn's specific complicated disease including active Stenotic (stricturing, B2) disease within the past 12 months, or Internal penetrating (B3) disease, or Draining perianal fistula, or Prior bowel resection * Patients with concomitant Celiac disease
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Participants Achieving Crohn's Disease Activity Index (CDAI) Clinical Response | Baseline, Week 8, Week 10, Week 18 | 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. |
| Participants Achieving Fecal Calprotectin (FC) Reduction | Baseline, Week 8, Week 10, Week 18 | Reduction is defined as a \>50% decrease from baseline in fecal calprotectin (FC). The outcome is the percentage of participants who achieve this reduction. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Participants Achieving Crohn's Disease Activity Index (CDAI) Clinical Remission | Baseline, Week 8, Week 10, Week 18 | 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. |
Countries
United States
Contacts
CONTACTEytan I Stern, MS, RD, LD/N, CNSC
PRINCIPAL_INVESTIGATOROriana M Damas, MD, MSCTI
University of Miami
Outcome results
None listed