Mediterranean Diet + Tirzepatide for Crohn's Disease

Recruiting in Palo Alto (17 mi)

Overseen by Oriana Damas, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 4

Recruiting

Sponsor: University of Miami

Stay on Your Current Meds

No Placebo Group

Prior Safety Data

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 am 18 years old or older.

I have been diagnosed with Crohn's disease.

BMI ≥ 27 kg/m2

Exclusion Criteria

I have an infection in my colon.

I have ulcerative colitis.

BMI<27 kg/m2

Trial 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 (GLP-1 Receptor Agonist)

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+

Sylvia Daunert

University of Miami

Chief Executive Officer since 2011

PhD in Biochemistry and Molecular Biology, University of Kentucky

Bahar Motlagh

University of Miami

Chief Medical Officer since 2021

PhD in Biomedical Engineering, Ecole Polytechnique Montreal