Health TrialsbyHealthPanel

Tailored Anti-Inflammatory American Diet for Patients With Crohn's Disease

ConditionsCrohn's Disease, ActiveCrohn's Disease (CD)Diet Interventions
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age16-75
SponsorUniversity of Miami

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Documented diagnosis with Crohn's Disease from medical records.

Ages 16-75

Disqualifiers

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

Trial design

Design model

Crossover

Treatments tested in this trial

  • 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.

  • 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.

Treatment groups

122 Participants
are divided into 2 treatment groups
Group A: Sequence A→B: Catered Anti-Inflammatory Diet Followed by Diet Guidance GroupExperimental treatment 2 interventions
Group B: Sequence B→A: Diet Guidance Followed by Catered Anti-Inflammatory Diet GroupExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

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.

Time frame
Baseline, Week 8, Week 10, Week 18
2

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.

Time frame
Baseline, Week 8, Week 10, Week 18

Secondary outcomes

1

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.

Time frame
Baseline, Week 8, Week 10, Week 18

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Miami

Lead sponsor

United States Department of Defense

Collaborator

Source ClinicalTrials.gov
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