Effects of a Mediterranean diet after liver transplantation
Official title: Effects of a Structured, Modified Mediterranean Dietary Intervention After Liver Transplantation
Run by Mayo Clinic · NCT04672863 · Data updated 2026-11-12
This study tests if following a Mediterranean diet can help people who have had a liver transplant maintain a healthy weight and improve their heart health over a year.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 80 (estimated) |
| Sponsor | Mayo Clinic Academic / other |
| Locations | 1 site (Rochester, Minnesota) |
| Status | Recruiting |
| Started | January 19, 2021 |
| Main results expected | March 1, 2027 |
| Study ends | November 2027 |
| Registry record updated | January 7, 2026 |
| Trial ID | NCT04672863 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults aged 18 and older who have undergone a primary liver transplant and have a BMI of 25 kg/m2 or higher.
✕Probably not a fit
Patients with uncontrolled diabetes, active eating disorders, or other serious medical conditions may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This study investigates the impact of a structured Mediterranean dietary program on post-liver transplant patients. It aims to prevent weight gain, promote heart health, and reduce the risk of fatty liver disease. Participants will be randomly assigned to either the dietary intervention group or the standard care group and will be followed for 12 months. The study will assess various health outcomes, including weight loss, insulin sensitivity, lipid profiles, and cardiovascular risk.
Why it matters
Potential benefit: If successful, this approach could significantly improve health outcomes and quality of life for liver transplant patients.
How similar studies have gone: Other studies have shown positive outcomes with dietary interventions in similar patient populations, suggesting potential for success in this approach.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria * Adult patients ≥ 18 years of age undergoing primary liver transplant * Ascites-adjusted BMI ≥ 25 kg/m2 * Acceptable graft function (total bilirubin level \< 5 mg/dL and doppler ultrasound with patent hepatic artery, hepatic veins and portal veins) Exclusion Criteria * Hepatocellular carcinoma (HCC) that did not fulfill Milan criteria as per explant histology * Untreated post-transplant vascular complications or biliary strictures * Multi-organ transplantation * Urine protein excretion ≥2.0 g/day * Uncontrolled diabetes mellitus (HbA1c \> 10%) * Associated medical conditions incompatible with safe participation in a nutritional intervention study, including digestive diseases with fat intolerance, neurological, psychiatric or endocrine disorders * Active eating disorder (e.g. bulimia nervosa, anorexia nervosa) * History of bariatric surgery * Pregnancy or planning on pregnancy in the next year
Where it's running
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Mayo Clinic in Rochester
Rochester, Minnesota, United States Recruiting
Study contacts
- Principal investigator: Kymberly Watt, MD — Mayo Clinic
- Study coordinator: Mohammad Qasim Khan, M.B.B.S.
- Email: khan.mohammadqasim@mayo.edu
- Phone: 507-284-3917
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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Everolimus-based calcineurin-free immunosuppression one year after liver transplant
This trial tests whether switching to or using everolimus with reduced calcineurin inhibitors after year one post-liver transplant can protect kidney function while maintaining graft health in adults at low rejection risk.
-
Sleep quality and its determinants during the liver transplant pathway
This study tests how sleep quality changes from before liver transplantation to six months after, in adults on the transplant waitlist at a single hospital.
-
Preoperative CIMT and Intraoperative Hemodynamics in Liver Transplant
This study looks at whether a higher carotid IMT measured before surgery is linked to more unstable blood pressure during liver transplant.
-
Reference framework for outcomes after machine-preserved liver transplantation in Europe
This study tests how liver transplants that use machine perfusion perform in real-world practice, to see how different perfusion methods relate to outcomes for adults in Europe.
-
Even protein distribution plus exercise for people awaiting liver transplant
This trial tests whether spreading daily protein evenly and combining it with a 12-week exercise program improves nutrition, muscle mass, and function in people waiting for a liver transplant compared with uneven protein timing or usual advice.
-
Preoperative Carbohydrate Loading Before Liver Transplant
This study tests whether drinking a carbohydrate beverage before anesthesia helps liver transplant patients recover faster.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.