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

NCT07671872 | Not Yet Recruiting

• 2 other identifiers: 20260433CDMRP-PR251962
• Study Type: interventional
• Target: 122
• Locations: 1 country
• Sites: 1

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.

Conditions

Crohn's Disease, Active; Crohn's Disease (CD); Diet Interventions

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• Participants Achieving Crohn's Disease Activity Index (CDAI) Clinical Remission

  Baseline, Week 8, Week 10, Week 18

Study Arms (2)

Sequence A→B: Catered Anti-Inflammatory Diet Followed by Diet Guidance Group

EXPERIMENTAL

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; Behavioral: Diet Guidance for Usual Diet

Sequence B→A: Diet Guidance Followed by Catered Anti-Inflammatory Diet Group

EXPERIMENTAL

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; Behavioral: Diet Guidance for Usual Diet

Interventions

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.

Sequence A→B: Catered Anti-Inflammatory Diet Followed by Diet Guidance Group; Sequence B→A: Diet Guidance Followed by Catered Anti-Inflammatory Diet Group

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.

Sequence A→B: Catered Anti-Inflammatory Diet Followed by Diet Guidance Group; Sequence B→A: Diet Guidance Followed by Catered Anti-Inflammatory Diet Group

Eligibility Criteria

• Age: 16 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Miami: lead
• United States Department of Defense: collaborator

Study Sites (1)

University of Miami

Miami, Florida, 33136, United States

Location

MeSH Terms

Conditions

Crohn Disease; Motor Activity

Condition Hierarchy (Ancestors)

Inflammatory Bowel Diseases; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases; Behavior

Study Officials

• Oriana M Damas, MD, MSCTI

  University of Miami

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Eytan I Stern, MS, RD, LD/N, CNSC

CONTACT

305-243-6405; eis43@miami.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Medicine

Study Record Dates

• First Submitted: June 22, 2026
• First Posted: June 26, 2026
• Study Start: August 1, 2026
• Primary Completion (Estimated): August 1, 2030
• Study Completion (Estimated): August 1, 2030
• Last Updated: June 26, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)