Crohn Disease
Tirzepatide and a Mediterranean Diet for Adults With Mild Crohn’s Disease
This pilot study is investigating tirzepatide-mediated weight loss and a Mediterranean diet in adults with mildly active Crohn’s disease, a body mass index of at least 27, and stable anti-tumor necrosis factor therapy.
Registry title: Glucagon-like Peptide-1 Receptor Agonist (GLP-1 RA) and Diet in Inflammatory Bowel Disease (IBD) Patients
1 recruiting U.S. site ↓Study at a glance
- Age
- 18 Years and older
- Treatment
- Tirzepatide or Mediterranean diet
- Design
- Randomized · Single
- Central study contact
- Stephanie Ioannou, MD305-243-2515s.ioannou@med.miami.edu
- Sponsor
- University of Miami
Research question
Researchers are asking what effect tirzepatide-mediated weight loss and a Mediterranean diet have on clinical response in adults with mildly active Crohn’s disease who remain on stable biologic therapy.
Participant snapshot
Who the study is looking for
- The study is looking for adults age 18 or older with a confirmed Crohn’s disease diagnosis.
- The study is looking for people with mildly active disease, defined as a Harvey-Bradshaw Index score from 5 through 7.
- The study is looking for people with a body mass index of at least 27 kg/m².
- The study is looking for people taking stable doses of anti-tumor necrosis factor therapy; the summary identifies infliximab or adalimumab.
- The listed recruiting location is the University of Miami in Miami, Florida.
Participation overview
What participation may involve
Participants follow a Mediterranean diet for up to 12 weeks. Those assigned to the tirzepatide group also give themselves weekly injections with increasing doses. The study tracks retention, adherence, calls, dietary recalls, symptom surveys, and completion of blood and stool samples. What participation may involve: - Follow Mediterranean-diet guidance, with encouragement to use the diet for up to three meals per day. - Attend weekly 30-minute guided dietary sessions with a dietitian. - If assigned to the tirzepatide group, take a weekly injection under the skin using the reported step-up dosing schedule. - Complete 24-hour dietary recalls and self-report medication adherence. - Complete study calls, clinical-symptom surveys, blood samples, and stool samples. Each study group is described as lasting up to 12 weeks. The registry reports weekly 30-minute dietitian sessions and calls that may occur by phone or Zoom, but it does not provide a complete visit schedule.
Study interventions
What participants may receive or do
- Tirzepatide: Participants assigned to the tirzepatide group receive a weekly injection under the skin: 2.5 mg for four weeks, 5 mg for four weeks, and 7.5 mg for the final four weeks. Injection sites may include the abdomen, thigh, or upper arm.
- Mediterranean diet: Participants in both groups receive Mediterranean-diet guidance, including a goal of 25–30 grams of fiber daily from fruits, vegetables, and whole grains, less animal protein, and minimally processed foods. The registry reports weekly 30-minute sessions with a dietitian.
Study design
How the comparison works
This Phase 4 pilot study plans to enroll 24 participants into two parallel groups for up to 12 weeks: tirzepatide plus a Mediterranean diet, or the Mediterranean diet alone. The registry states that participants are randomly assigned to one of the two parallel groups. The study is listed as single-masked, with participants identified as the masked group. The diet-only group provides a comparison with the group receiving tirzepatide plus the same Mediterranean-diet intervention.
Reported activities
Procedures and tests
- Weekly injections under the skin for participants assigned to tirzepatide.
- Weekly 30-minute guided dietitian sessions.
- Twenty-four-hour dietary-recall assessments, including ASA24 surveys.
- Self-reported medication-adherence assessments.
- Study calls conducted by phone or virtually through Zoom.
- Clinical-symptom surveys using the Harvey-Bradshaw Index or Crohn’s Disease Activity Index.
- Collection of blood samples.
- Collection of stool samples.
- Screening may include confirming pregnancy status with a pregnancy test.
Eligibility highlights
Details that may affect whether you contact the study
These are selected highlights, not a complete eligibility check. Exact criteria remain in the full registry record below.
Common requirements
- Participants must be adults age 18 or older.
- Participants must have a confirmed diagnosis of Crohn’s disease.
- Disease must be mildly active, defined as a Harvey-Bradshaw Index score from 5 through 7.
- Body mass index must be at least 27 kg/m².
- Participants must be taking stable doses of anti-tumor necrosis factor alpha-blocker therapy.
Possible reasons someone may not be able to join
- People with ulcerative colitis or infectious colitis are excluded.
- People with type 1 or type 2 diabetes are excluded.
- People with a contraindication to a glucose-dependent insulinotropic polypeptide/glucagon-like peptide-1 receptor agonist are excluded, including those with a personal or family history of medullary thyroid cancer or Multiple Endocrine Neoplasia syndrome type 2.
- People already taking a glucose-dependent insulinotropic polypeptide/glucagon-like peptide-1 receptor agonist are excluded.
- People with chronic severe constipation, nausea, or vomiting are excluded.
- People are excluded if they had a small-bowel obstruction within the past year, have an intestinal stricture, or have known or suspected gastroparesis.
- Adults who cannot provide consent are excluded.
- Pregnant people are excluded, and pregnancy will be checked with a test.
- Prisoners are excluded.
Important unknowns
What the record does not make clear
- Weekly 30-minute dietitian sessions and phone or Zoom calls are mentioned, but the complete number, timing, location, and length of study visits are not reported.
- Stable anti-tumor necrosis factor therapy is required, and the summary names infliximab or adalimumab, but the record does not explain whether doses must remain unchanged throughout the study.
- The registry does not describe washout rules or timing restrictions for medications other than the exclusion of people already using a GIP/GLP-1 receptor agonist.
- The registry does not explain what treatment is available if Crohn’s symptoms worsen during the study.
- The registry does not state whether screening or follow-up endoscopy is required.
- The registry does not state which study drugs, tests, visits, or usual-care services are paid for or billed to insurance.
- The registry does not report whether participants receive compensation.
- The registry does not report reimbursement or support for travel, parking, lodging, or meals.
- Some calls may occur by phone or Zoom, but the registry does not state which other activities require travel to the Miami site.
- The registry does not state whether tirzepatide or dietitian support is available after the intervention ends.
Before contacting the site
Questions for the study team
- What is the complete schedule for visits, dietitian sessions, calls, blood draws, stool collections, and surveys?
- How is participant masking maintained when only one group receives weekly tirzepatide injections?
- Must my infliximab or adalimumab dose and schedule remain unchanged, and what happens if a medical change becomes necessary?
- What side-effect monitoring and treatment are provided, and what happens if Crohn’s symptoms worsen?
- Is endoscopy required for screening or follow-up, and how will mildly active Crohn’s disease be confirmed?
- Which costs are covered, is compensation offered, and is help available for travel or parking?
- What happens to tirzepatide and dietitian support after the 12-week intervention ends?
Before changing care
Questions for your gastroenterologist
- How stable is my Crohn’s disease now, and does a Harvey-Bradshaw Index score of 5 through 7 reflect my current symptoms?
- Could tirzepatide’s gastrointestinal effects complicate my Crohn’s symptoms or any history of obstruction, stricture, constipation, nausea, vomiting, or delayed stomach emptying?
- Would my current infliximab or adalimumab treatment need to change, and how should routine Crohn’s care be coordinated with the research team?
- What approved treatment and weight-management alternatives should I understand before considering this study?
- If my symptoms worsen during the study, how should my gastroenterology team and the research team coordinate urgent evaluation and treatment?
This plain-language digest is provided by the Aidy clinical trials API. It may omit details and is not medical advice or an eligibility decision. Review the full registry record and confirm details with the study team.
Source record
Full registry record
The sections below preserve the study information supplied through ClinicalTrials.gov, including complete descriptions, criteria, outcomes, and locations.
About this study
The purpose of this study is to use diet and an injectable medication called tirzepatide (Zepbound) glucose-dependent insulinotropic polypeptide and glucagon-like peptide-1 receptor agonist (GIP-GLP-1 RA) medication as adjunctive therapy (another treatment used together with the primary treatment) for Crohn's disease patients with mild disease who are on stable doses of biologic medication (infliximab or adalimumab) and who have a body mass index (BMI) of at least 27.
Study design and administration
- Organization
- University of Miami
- Organization class
- Other
- Organization study ID
- 20240982
- Lead sponsor
- University of Miami
- Sponsor class
- Other
- Enrollment type
- Estimated
- Allocation
- Randomized
- Intervention model
- Parallel
- Primary purpose
- Supportive Care
- Masking
- Single
- Who is masked
- Participant
- Standard age groups
- Adult, Older Adult
Study arms
Experimental
Tirzepatide group
Participants will be in this group for up to 12 weeks.
Interventions: Drug: Tirzepatide, Behavioral: Mediterranean diet
Experimental
Mediterranean diet group
Participants will be in this group for up to 12 weeks.
Interventions: Behavioral: Mediterranean diet
Interventions
Drug
Tirzepatide
Patients in this arm will receive tirzepatide starting at 2.5 mg subcutaneous (SC) weekly for 4 weeks, then increase to 5 mg SC weekly for 4 weeks and then 7.5 mg SC weekly for the last 4 weeks of the intervention period. Place of injection includes abdomen, thigh, or upper arm.
Behavioral
Mediterranean diet
The diet is comprised of a content of 25-30 grams of fiber per day (from fruits, vegetables, whole grains) that is low in animal protein and minimally processing of foods The diet arm will receive dietary guidance from our dietician on weekly 30-minute guided sessions. Participants will be encouraged to adhere to the diet for up to three meals per day for the duration of the study.
Eligibility
18 Years and older
All
Not accepted
Inclusion criteria (5)
- Adult patients (≥18 years old)Registry-derived · unreviewed
- Confirmed diagnosis of Crohn's diseaseRegistry-derived · unreviewed
- Mildly active disease, defined by clinical symptoms using the Harvey Bradshaw Index (HBI) score between 5 and 7 (the HBI is a continuous score ranging from 0-16 where \<4 is considered remission)Registry-derived · unreviewed
- BMI ≥ 27 kg/m2Registry-derived · unreviewed
- Patients will be on stable doses of medical therapy (anti-tumor necrosis factor (TNF) alpha blockers)Registry-derived · unreviewed
Exclusion criteria (12)
- Patients under 18 years of ageRegistry-derived · unreviewed
- Patients with ulcerative colitisRegistry-derived · unreviewed
- Patients with infectious colitisRegistry-derived · unreviewed
- BMI\<27 kg/m2Registry-derived · unreviewed
- Patients with type 1 or type 2 diabetesRegistry-derived · unreviewed
- Contraindications to a GIP/GLP-1 RA, including patients with a personal or family history of medullary thyroid cancer or in patients with Multiple Endocrine Neoplasia syndrome type 2Registry-derived · unreviewed
- Patients already on GIP/GLP-1 RA therapyRegistry-derived · unreviewed
- Patients with the following chronic symptoms: severe constipation, nausea, and/or vomitingRegistry-derived · unreviewed
- Patients with the following medical history: small bowel obstruction in the last year, intestinal stricture, known or suspected diagnosis of gastroparesisRegistry-derived · unreviewed
- Adults unable to consentRegistry-derived · unreviewed
- Pregnant patients (will be confirmed via a pregnancy test)Registry-derived · unreviewed
- PrisonersRegistry-derived · unreviewed
This information can identify a possible match, conflict, or item needing confirmation. Only the study team can determine eligibility.
Study outcomes
Primary outcome
Change in percentage of participants retained
Time frame: Baseline, 12 weeks
The percentage of participants retained will be measured
Primary outcome
Number of patients who adhere to diet measured by 24 hour dietary recall
Time frame: Up to 12 weeks
Number of patients who adhere to diet measured by 24 hour dietary recall
Primary outcome
Number of patients who adhere to medications measured by self report
Time frame: Up to 12 weeks
Number of patients who adhere to medications measured by self report
Secondary outcome
Number of calls completed
Time frame: Up to 12 weeks
Number of calls completed. Calls will be made either on a phone or virtually using Zoom.
Secondary outcome
Number of dietary recall (ASA24) surveys completed
Time frame: Up to 12 weeks
Number of dietary recall (ASA24) surveys completed
Secondary outcome
Number of clinical symptom (HBI/CDAI) surveys completed
Time frame: Up to 12 weeks
Number of clinical symptom (HBI/CDAI) surveys completed
Secondary outcome
Number of blood samples completed
Time frame: Up to 12 weeks
Number of blood samples completed
Secondary outcome
Number of stool samples completed
Time frame: Up to 12 weeks
Number of stool samples completed
Recruiting locations in the United States
University of Miami
RecruitingMiami, Florida, 33136, United States
Michael Mijares, CRC305-243-6405mmijares74@med.miami.edu
Oriana Damas, MD
Stephanie Ioannou, MD
Central study contacts
Registry dates
- First posted
- Jan 14, 2025
- Primary completion
- Mar 5, 2027
- Overall completion
- Mar 5, 2027
Trial information comes from ClinicalTrials.gov and may change. Confirm current status, eligibility, and site details with the study team. Aidy does not provide medical advice or determine eligibility.