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NOT YET RECRUITING
NCT07671872
NA

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

Sponsor: University of Miami

View on ClinicalTrials.gov

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.

Official title: Targeting Gut Inflammation Through Diet: a Tailored American Diet for Patients With Crohn's Disease

Key Details

Gender

All

Age Range

16 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

122

Start Date

2026-08

Completion Date

2030-08

Last Updated

2026-06-26

Healthy Volunteers

No

Interventions

BEHAVIORAL

Catered 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.

BEHAVIORAL

Diet 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.

Locations (1)

University of Miami

Miami, Florida, United States