NCT04672863 Mediterranean Diet Post-liver Transplantation
| NCT ID | NCT04672863 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Mayo Clinic |
| Condition | Liver Transplantation |
| Study Type | INTERVENTIONAL |
| Enrollment | 80 participants |
| Start Date | 2021-01-19 |
| Primary Completion | 2027-03-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 80 participants in total. It began in 2021-01-19 with a primary completion date of 2027-03-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The purpose of this study is to study the effects of a structured Mediterranean dietary program on prevention of weight gain, promotion of heart health and prevention of fatty liver disease after liver transplantation.
Eligibility 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
Contact & Investigator
Kymberly Watt, MD
PRINCIPAL INVESTIGATOR
Mayo Clinic
Frequently Asked Questions
Who can join the NCT04672863 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Liver Transplantation. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04672863 currently recruiting?
Yes, NCT04672863 is actively recruiting participants. Contact the research team at khan.mohammadqasim@mayo.edu for enrollment information.
Where is the NCT04672863 trial being conducted?
This trial is being conducted at Rochester, United States.
Who is sponsoring the NCT04672863 clinical trial?
NCT04672863 is sponsored by Mayo Clinic. The principal investigator is Kymberly Watt, MD at Mayo Clinic. The trial plans to enroll 80 participants.