Medically-Tailored Meals to Prevent Recurrent Hepatic Encephalopathy: The BRAINFOOD Pilot Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 17
- 试验地点
- 1
- 主要终点
- Overall Participant Retention Rate Based on Proportion of Participants Who Complete All Study Visits
研究概览
简要总结
This study is being completed for patients with cirrhosis, including patients with a prior history of hepatic encephalopathy (HE) to evaluate the feasibility and benefits of medically-tailored meals as an intervention.
Patients will be enrolled from the University of Michigan and will complete the baseline assessments in-person or remotely. In addition participants will complete study related materials before, during and after treatment with medically-tailored meals (MTM). After completing the study meals, participants will return for follow-up or have this visit completed remotely as well as have an observational period for 12 more weeks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 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
- •Diagnosis of cirrhosis will be based upon:
- •liver biopsy, OR
- •history of cirrhosis complication: ascites, variceal bleeding, hepatic encephalopathy, OR
- •2 of the following 4 criteria:
- •Ultrasound, Computed tomography (CT), or Magnetic resonance imaging (MRI) findings of cirrhosis (cirrhotic appearing liver, splenomegaly, varices, ascites)
- •Fibroscan liver stiffness score >13 kilopascals (kPa)
- •Laboratory testing: aspartate aminotransferase/platelet ratio index (APRI) >2.0
- •CT, MRI or esophagogastroduodenoscopy (EGD) showing presence of esophageal varices
- •Patients with history of > grade 2 HE within 180 days of enrollment based on review of clinical documentation verifying the event. If a description of HE symptoms is provided in clinical documentation, but it is unclear if it meets Grade 2 criteria, the principal investigator will assess the clinical documentation and provide an HE grade.
排除标准
- •Non-English speaking
- •Model for End-Stage Liver Disease (MELD) Score > 20
- •Pregnancy (self-reported)
- •Unable or unwilling to provide consent
- •History of liver transplant
- •Current or planned admission to a nursing facility
- •Serum creatinine > 2.0 milligrams per deciliter (mg/dL) (with the exception that we will include patients with a serum creatinine > 2.0 mg/dL if they are receiving hemodialysis)
- •Disorientation at the time of enrollment
- •Barcelona-Clinic Liver Cancer (BCLC) Stage D Hepatocellular Carcinoma with Child-Turcotte-Pugh (CTP) Class C
- •History of eating disorder
研究组 & 干预措施
Medically-tailored meals
Participants will receive meals that adhere to their specified nutritional targets dependent upon their cirrhosis complication of hepatic encephalopathy (HE) and/or ascites. Participants with HE will receive high-protein (approximately 1 gram of medication per kilogram of the body weight (1g/kg/day) and high-calorie (approximately 30c/kg/day) meals. Participants with HE and ascites will receive high-protein and high-calorie meals that are also low-sodium (less than or equal to 2000 milligrams a day).
干预措施: Medically-tailored meals (MTM) (Other)
Medically-tailored meals
Participants will receive meals that adhere to their specified nutritional targets dependent upon their cirrhosis complication of hepatic encephalopathy (HE) and/or ascites. Participants with HE will receive high-protein (approximately 1 gram of medication per kilogram of the body weight (1g/kg/day) and high-calorie (approximately 30c/kg/day) meals. Participants with HE and ascites will receive high-protein and high-calorie meals that are also low-sodium (less than or equal to 2000 milligrams a day).
干预措施: Protein supplements (Dietary Supplement)
Medically-tailored meals
Participants will receive meals that adhere to their specified nutritional targets dependent upon their cirrhosis complication of hepatic encephalopathy (HE) and/or ascites. Participants with HE will receive high-protein (approximately 1 gram of medication per kilogram of the body weight (1g/kg/day) and high-calorie (approximately 30c/kg/day) meals. Participants with HE and ascites will receive high-protein and high-calorie meals that are also low-sodium (less than or equal to 2000 milligrams a day).
干预措施: Nutrition education handout (Behavioral)
结局指标
主要结局
Overall Participant Retention Rate Based on Proportion of Participants Who Complete All Study Visits
时间窗: up to 27 weeks post enrollment
Overall participant retention rate based on proportion of participants who completed all study visits
Participant Adherence Rate to Medically-Tailored Meals (MTM)
时间窗: up to 11 weeks post enrollment
The participant adherence rate to MTM based on proportion of participants who consumed ≥75% of delivered meals and evening snack
次要结局
- Proportion of Participants Who Completed All Study Assessments and Procedures(up to 27 weeks post enrollment)
- Eligible Candidates Who Enrolled After Screening(approximately 1 year (enrollment period))
- The Percentage of Enrolled Participants Who Dropped Out of Study(up to 27 weeks)
- Time Required to Complete Assessments(Up to 90 minutes)
研究者
Elliot B. Tapper
Assistant Professor of Internal Medicine
University of Michigan