NCT07671872 · University of Miami
Tailored Anti-Inflammatory American Diet for Patients With Crohn's Disease
What this study is about
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.
View original scientific description
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.
Interventions
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.
Primary outcome measures
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.
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Documented diagnosis with Crohn's Disease from medical records.
- 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
- 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
Where
- Miami, Florida
Collaborators
United States Department of Defense
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Sep 24, 2026 · Source of record for eligibility and locations