Mediterranean Diet Post-liver Transplantation
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Liver Transplantation
- Type
- Interventional
- Phase
- Not Applicable
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentMasking: None (Open Label)Primary Purpose: Supportive Care
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
Description
Study Hypotheses A modified Mediterranean diet after liver transplantation results in weight loss, improvement of insulin sensitivity, lipid profiles, blood pressure, BMI, and waist circumference in patients who adhere to the program. A modified Mediterranean diet after liver transplantation results...
Study Hypotheses A modified Mediterranean diet after liver transplantation results in weight loss, improvement of insulin sensitivity, lipid profiles, blood pressure, BMI, and waist circumference in patients who adhere to the program. A modified Mediterranean diet after liver transplantation results in relative improvement in cardiovascular outcomes in patients who adhere to the program when compared to standard of care. A modified Mediterranean diet after liver transplantation results in relative improvement in 10-year ASCVD risk in patients who adhere to the program when compared to standard of care. A modified Mediterranean diet after liver transplantation decreases the risk of development of NAFLD/NASH/NASH fibrosis in patients who adhere to the program. Study Design: Single-center, prospective, randomized interventional trial All eligible post-liver transplant patients during the enrollment period will be invited to participate in the trial. All enrolled patients will be randomized to the Dietary Intervention (DI) arm or the Standard of Care (SOC) arm. All patients will be followed for 12 months.
Tracking Information
- NCT #
- NCT04672863
- Collaborators
- Not Provided
- Investigators
- Principal Investigator: Kymberly Watt, MD Mayo Clinic