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

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Crohn's Disease, Active; Crohn's Disease (CD); Diet Interventions
• Intervention / Treatment: Behavioral: Catered Anti-Inflammatory Diet; Behavioral: Diet Guidance for Usual Diet

• Study Type: Interventional
• Enrollment (Estimated): 122
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Eytan I Stern, MS, RD, LD/N, CNSC; Phone Number: 305-243-6405; Email: eis43@miami.edu

Study Locations

• United States
  • Florida
    • Miami, Florida, United States, 33136
      • University of Miami
      • Contact: Eytan I Stern, MS, RD, LD/N, CNSC; Phone Number: 305-243-6405; Email: eis43@miami.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Sequence A→B: Catered Anti-Inflammatory Diet Followed by Diet Guidance Group; 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.	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.
Experimental: Sequence B→A: Diet Guidance Followed by Catered Anti-Inflammatory Diet Group; 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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: University of Miami
• Collaborators: United States Department of Defense
• Investigators: Principal Investigator: Oriana M Damas, MD, MSCTI, University of Miami

Study record dates

Study Major Dates

• Study Start (Estimated): August 1, 2026
• Primary Completion (Estimated): August 1, 2030
• Study Completion (Estimated): August 1, 2030

Study Registration Dates

• First Submitted: June 22, 2026
• First Submitted That Met QC Criteria: June 22, 2026
• First Posted (Actual): June 26, 2026

Study Record Updates

• Last Update Posted (Actual): June 26, 2026
• Last Update Submitted That Met QC Criteria: June 22, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Intestinal Diseases; Digestive System Diseases; Gastrointestinal Diseases; Gastroenteritis; Inflammatory Bowel Diseases; Behavior; Crohn Disease; Motor Activity
• Other Study ID Numbers: 20260433; CDMRP-PR251962 (Other Grant/Funding Number: Defense Health Agency)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No