Crohn's Disease, ActiveNCT07671872
Tailored Anti-Inflammatory American Diet for Patients With Crohn's Disease
A study testing Catered Anti-Inflammatory Diet and Diet Guidance for Usual Diet in people with Crohn's Disease, Active and Crohn's Disease (CD), run by University of Miami at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 16 to 75 years
- Conditions the study is for
- Crohn's Disease, Active, Crohn's Disease (CD), Diet Interventions
- What is being tested?
- Catered Anti-Inflammatory Diet and Diet Guidance for Usual Diet
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 122 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Sep 2026to Aug 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 75 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 16Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Miami
Miami, Florida, 33136
Eytan I Stern, MS, RD, LD/N, CNSC, 305-243-6405, eis43@miami.edu
About this study
Official title: 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.
- Being tested
- Catered Anti-Inflammatory Diet, Diet Guidance for Usual Diet
- Medical subject headings
- Crohn Disease, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Catered Anti-Inflammatory DietBehavioural
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 DietBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Catered Anti-Inflammatory Diet; Behavioral: Diet Guidance for Usual Diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Baseline, Week 8, Week 10, Week 18
Secondary outcomes (1)
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.
Measured: Baseline, Week 8, Week 10, Week 18
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2026
- Study start16 Sep 2026
- Primary completionAug 2030 (estimated)
- Study completionAug 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Crohn's Disease, ActiveStudies of the same condition, open and under way.
- More trials run by University of MiamiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 122 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Miami
- Sponsor type
- University, hospital or other
- Collaborators
- United States Department of Defense
- Responsible party
- Principal investigator, Oriana Mazorra Damas, University of Miami
- Investigators
- Oriana M Damas, MD, MSCTI, Principal investigator, University of Miami
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07671872
- Sponsor's protocol ID
- 20260433
- Other IDs
- CDMRP-PR251962
- Status last verified
- Sep 2026
- First submitted
- 22 Jun 2026
- Last updated
- 24 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Targeting Gut Inflammation Through Diet: a Tailored American Diet for Patients With Crohn's Disease
- ClinicalTrials.gov ID
- NCT07671872
- Acronym / sponsor ID
- 20260433
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 122 participants (estimated)
- Lead sponsor
- University of MiamiUniversity, hospital or other
- Collaborators
- United States Department of Defense
- Study start
- 16 Sep 2026 (actual)
- Primary completion
- Aug 2030 (estimated)
- Study completion
- Aug 2030 (estimated)
- First posted
- 26 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sequence A→B: Catered Anti-Inflammatory Diet Followed by Diet Guidance Group | Experimental | Behavioral: Catered Anti-Inflammatory Diet, Behavioral: Diet Guidance for Usual DietParticipants 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. |
| Sequence B→A: Diet Guidance Followed by Catered Anti-Inflammatory Diet Group | Experimental | Behavioral: Catered Anti-Inflammatory Diet, Behavioral: Diet Guidance for Usual DietParticipants 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. |
Who may qualify
- Ages
- 16 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (16 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Catered Anti-Inflammatory DietParticipants 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. | Behavioural | 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 DietParticipants 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. | Behavioural | Sequence A→B: Catered Anti-Inflammatory Diet Followed by Diet Guidance Group, Sequence B→A: Diet Guidance Followed by Catered Anti-Inflammatory Diet Group |
Primary outcome
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.
1 secondary outcome
Participants Achieving Crohn's Disease Activity Index (CDAI) Clinical Remission
Time frame: Baseline, Week 8, Week 10, Week 18
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2026.
- Individual participant dataSharing planned: No
Related trials for Crohn's Disease, Active
Not yet recruitingPhase 1
An Open-label, DDI Study to Investigate the Effects of Duvakitug on the PK of Selected Cytochrome P450 Substrates
Ulcerative Colitis, Crohn's Disease
RecruitingPhase 3
A Study to Assess the Pharmacokinetics, Effectiveness and Safety of Afimkibart for Induction and Maintenance Therapy in Children With Moderately to Severely Active Crohn's Disease
Moderately to Severely Active Crohns Disease
RecruitingPhase 3
Mirikizumab and Tirzepatide Administered in Adult Participants With Moderately to Severely Active Crohn's Disease and Obesity or Overweight
Crohn's Disease, Obesity or Overweight
RecruitingPhase 2
A Master Protocol (IIBD): A Study of Multiple Drugs in Adults With Ulcerative Colitis or Crohn's Disease
Colitis, Ulcerative, Crohn Disease
Not yet recruiting
Effects of Different Physical Activity Strategies on Disease Activity of IBD Patients
Inflammatory Bowel Disease (Crohn's Disease and Ulcerative Colitis)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Oriana M Damas, MD, MSCTI principal investigator
University of Miami
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Catered Anti-Inflammatory Diet and Diet Guidance for Usual Diet in people with Crohn's Disease, Active and Crohn's Disease (CD), run by University of Miami at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 24 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Eytan I Stern, MS, RD, LD/N, CNSC (305-243-6405, eis43@miami.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Participants Achieving Crohn's Disease Activity Index (CDAI) Clinical Response (time frame: Baseline, Week 8, Week 10, Week 18). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Sep 2026.