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NCT Number: NCT07671872

Tailored Anti-Inflammatory 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.

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Key information

Age range

16 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

Primary outcomes

  1. Participants Achieving Crohn's Disease Activity Index (CDAI) Clinical Response

    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.

  2. Participants Achieving Fecal Calprotectin (FC) Reduction

    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.

Secondary outcomes

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

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

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

CONTACT

[email protected]

305-243-6405

Sponsors and collaborators

Lead sponsor

University of Miami

Other

Collaborators

  • United States Department of Defense

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2030
Study completion
2030
First posted
Jun 26, 2026
Registry last updated
Jun 26, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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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