University of Miami
Miami, Florida, 33136, United States
NCT Number: NCT07671872
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.
Trial opening soon.
Get Notified16 year–75 year
All sexes
Interventional
Not applicable
Miami, Florida, 33136, United States
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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
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.
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Contact information is provided by the study sponsor or research team.
University of Miami
Other
Targeting Gut Inflammation Through Diet: a Tailored American Diet for Patients With Crohn's Disease
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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