Effects of a Structured, Modified Mediterranean Dietary Intervention After Liver Transplantation
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- Mayo Clinic
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- weight gain
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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)
排除标准
- •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
研究组 & 干预措施
Standard of Care Group
Subjects will participate in a standardized Transplant Nutrition class between day 21-40 as per institutional protocol and will be counseled as per the Mayo Clinic standard of care vis a vis dietary intervention, standard aerobic and resistance exercise recommendations (consistent with AASLD guidelines) and other lifestyle interventions.
Behavioral: Structured Modified Mediterranean Diet
Subjects will participate in a one-on-one counselling session with a dietician, as opposed to attending the standardized Transplant Nutrition class. Counselling will be provided on the elements of the modified Mediterranean diet which emphasizes consumption of fruits, vegetables, whole grains, beans and nuts, in addition to low salt, moderate amounts of lean protein (primarily fish and poultry) in addition to low to moderate quantities of monounsaturated fats.
干预措施: Dietary Intervention (Behavioral)
结局指标
主要结局
weight gain
时间窗: 12 months
weight in kilograms
weight gain
时间窗: 4 months
weight in kilograms
次要结局
- fat mass changes(12 months)
- fat mass changes(4 months)
研究者
Kymberly D. Watt
Principal Investigator
Mayo Clinic