Mediterranean Diet + Tirzepatide for Crohn's Disease

Overseen By Stephanie Ioannou, MD

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: University of Miami

Must be taking: Biologics

Must not be taking: GIP-GLP-1 RAs

Disqualifiers: Diabetes, Ulcerative colitis, Pregnancy, others

Stay on Your Current Meds You can continue your current medications while participating

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 12 weeks

24 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Research Team

Oriana Damas, MD

Principal Investigator

University of Miami

Eligibility Criteria

This trial is for Crohn's disease patients with mild symptoms, on stable biologic meds (infliximab or adalimumab), and a BMI of at least 27. It aims to see if adding a Mediterranean diet and tirzepatide injections helps manage their condition.

Inclusion Criteria

I have been diagnosed with Crohn's disease.

BMI ≥ 27 kg/m2

I am on a stable dose of medication for inflammation.

Exclusion Criteria

I have an infection in my colon.

I have ulcerative colitis.

BMI<27 kg/m2

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either a Mediterranean diet or tirzepatide for up to 12 weeks

12 weeks

Regular visits for monitoring and surveys

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Tirzepatide

Trial Overview The study tests the combination of a Mediterranean diet and tirzepatide injections as additional treatments for Crohn's disease. Tirzepatide is an injectable medication that affects insulin and glucagon levels in the body.

Participant Groups

Group I: Tirzepatide group Experimental Treatment 2 Interventions

Participants will be in this group for up to 12 weeks.

Group II: Mediterranean diet group Experimental Treatment 1 Intervention

Participants will be in this group for up to 12 weeks.

Who Is Running the Clinical Trial?

University of Miami

Lead Sponsor

Trials

976

Recruited

423,000+