Recruiting

Anti-Inflammatory Diet

Sponsor:

University of Miami

Code:

NCT07671872

Conditions

Crohn's Disease, Active

Crohn's Disease (CD)

Diet Interventions

Eligibility Criteria

Sex: All

Age: 16 - 70+

Healthy Volunteers: Not accepted

Interventions

Catered Anti-Inflammatory Diet

Diet Guidance for Usual Diet

Study Details

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

Study ID

NCT07671872

Start date

Sep 16, 2026

Status verified date

Sep, 2026

Completion date

Aug, 2030

Anticipated

Primary completion date

Aug, 2030

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 16 - 70+

Healthy Volunteers: Not accepted

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 Design

Enrollment

122 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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.

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.

Interventions

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.

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.

Primary outcome measure

  • Participants Achieving Crohn's Disease Activity Index (CDAI) Clinical Response [ Time Frame: Baseline, Week 8, Week 10, Week 18 ]
  • Participants Achieving Fecal Calprotectin (FC) Reduction [ Time Frame: Baseline, Week 8, Week 10, Week 18 ]

Central Contacts and Locations

Central contacts

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

305-243-6405eis43@miami.edu

Locations

University of Miami

Recruiting

Miami, Florida, United States, 33136

Contacts

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

305-243-6405eis43@miami.edu

More Information

Sponsor

University of Miami

Last update posted

Sep 24, 2026

Last verified

Sep, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-25. This information was provided to ClinicalTrials.gov by University of Miami on 2026-09-24. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.