Effects of a Mediterranean diet after liver transplantation
Effects of a Structured, Modified Mediterranean Dietary Intervention After Liver Transplantation
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
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 80 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Mayo Clinic Academic / other |
| Locations | 1 site (Rochester, Minnesota) |
| Trial ID | NCT04672863 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
Not a fit: Patients with uncontrolled diabetes, active eating disorders, or other serious medical conditions may not benefit from this study.
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 performed: Other studies have shown positive outcomes with dietary interventions in similar patient populations, suggesting potential for success in this approach.
Eligibility criteria
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 this trial is running
Rochester, Minnesota
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.