Mediterranean Diet + Tirzepatide for Crohn's Disease
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a combination of a Mediterranean diet and an injectable medication called tirzepatide to determine their effectiveness in managing Crohn's disease. It targets individuals with mild Crohn's who are already on certain medications (biologics) and have a body mass index (BMI) of 27 or higher. Participants will either follow the diet plan or take the medication for up to 12 weeks. Those experiencing mild Crohn's symptoms and meeting these criteria may find this trial beneficial. As a Phase 4 trial, the research aims to understand how an already FDA-approved and effective treatment can benefit more patients.
Will I have to stop taking my current medications?
No, you won't have to stop your current medications. The trial requires participants to be on stable doses of their existing biologic medications like infliximab or adalimumab.
What is the safety track record for the Mediterranean diet and tirzepatide treatment?
Research has shown that tirzepatide might cause more side effects in people with inflammatory bowel disease (IBD), such as Crohn's disease, than in those without IBD. About 58% of people with IBD reported side effects, such as nausea, compared to 27% of those without IBD. Some individuals also experienced higher liver enzyme levels, indicating potential liver stress.
While researchers are studying tirzepatide for its effects on Crohn's disease, it is already approved for treating other conditions, like type 2 diabetes. This approval suggests a good understanding of its safety, although reactions can vary depending on the condition being treated.
Overall, while side effects are a consideration, the approval of tirzepatide for other uses provides some reassurance about its safety. Participants should consult their doctor about potential risks to make an informed decision.12345Why are researchers enthusiastic about this study treatment?
Researchers are excited about using tirzepatide for Crohn's disease because it offers a fresh approach compared to standard treatments like biologics (e.g., infliximab) and immunosuppressants (e.g., azathioprine). Tirzepatide is a dual agonist that targets both GLP-1 and GIP receptors, which may help regulate inflammation and gut health differently than current options. Additionally, pairing tirzepatide with a Mediterranean diet could enhance its effectiveness by leveraging anti-inflammatory nutrition, providing a holistic strategy that sets it apart from traditional therapies.
What evidence suggests that this trial's treatments could be effective for Crohn's disease?
This trial will compare the effects of the Mediterranean diet and Tirzepatide on Crohn's Disease. Research has shown that the Mediterranean diet can improve well-being and reduce symptoms such as pain and fatigue in people with Crohn's Disease. Studies have found that this diet helps manage the disease at various stages.
Tirzepatide, which participants in this trial may receive, is an injectable medication that targets certain hormones to control weight and metabolism. For individuals with inflammatory bowel disease (IBD), such as Crohn's, tirzepatide has been shown to aid in weight loss, potentially leading to better overall health. While researchers continue to study all of tirzepatide's effects on Crohn's Disease, its potential benefits appear promising, particularly for those who are overweight.678910Who Is on the Research Team?
Oriana Damas, MD
Principal Investigator
University of Miami
Are You a Good Fit for This Trial?
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
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive either a Mediterranean diet or tirzepatide for up to 12 weeks
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
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.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Participants will be in this group for up to 12 weeks.
Participants will be in this group for up to 12 weeks.
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Miami
Lead Sponsor
Citations
Mediterranean Diet & Crohn's: Disease Activity & Quality of Life
We conclude, according to the results of the study, that adherence to the MD is associated with disease activity and QoL in patients with CD.
A Randomized Trial Comparing the Specific Carbohydrate ...
This study compared the effectiveness of the Specific Carbohydrate Diet (SCD) to the Mediterranean diet (MD) as treatment for Crohn's disease ( ...
Adherence to a Mediterranean dietary pattern is associated ...
The Mediterranean Diet (MD) was recently found to have benefits for patients with Crohn's Disease (CD) in various stages of the disease, though adherence to ...
4.
pcori.org
pcori.org/research-results/2016/comparing-two-diets-decrease-symptoms-crohns-disease-dine-cd-studyComparing Two Diets to Decrease Symptoms from Crohn's ...
Overall, patients on each diet reported improved quality of life and less pain, fatigue, sleep disturbance, and feelings of isolation from family and friends at ...
781 COMPARATIVE EFFECTIVENESS OF ...
Conclusions. Symptomatic remission was achieved in ≥40% with both diets regardless of confirmed inflammation. CRP response was uncommon. None of the ...
6.
journals.lww.com
journals.lww.com/ajg/fulltext/2025/10002/s1890_safety_and_weight_loss_outcomes_of.1891.aspxS1890 Safety and Weight Loss Outcomes of Tirzepatide in...
Overall side effects were numerically higher in the IBD group (58%) compared to controls (27%, P = 0.009). IBD patients experienced higher rates of nausea/ ...
Dramatic Changes in Thiopurine Metabolite Levels in a ...
Following tirzepatide initiation, she experienced elevated liver enzymes associated with a significant increase in thiopurine metabolite levels.
NCT06976853 | Moving Beyond Inflammation as a ...
The purpose of this research study is to evaluate what type of treatment will be beneficial for people with Crohn's disease and difficult to treat ...
Glucagon-like peptide-1 (GLP-1) receptor agonists in ...
This review synthesizes the mechanistic rationale, pre-clinical evidence, and clinical data to date, highlighting the potential utility and safety ...
10.
gastroendonews.com
gastroendonews.com/Inflammatory-Bowel-Disease/Article/05-25/The-Impact-of-GLP-1s-on-Patients-With-IBD/77091The Impact of GLP-1s on Patients With IBD
Obesity, especially when manifested by visceral adipose tissue, seems to be associated with worse IBD outcomes.
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