Resveratrol and Human Hepatocyte Function in Cancer
试验速览
- 阶段
- 1 期
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Improved metabolic profile of liver cells
研究概览
简要总结
The purpose of this study is to determine if Resveratrol, a nutritional supplement, shows a beneficial effect in the cellular function of normal liver cells and diseased liver cells (cancer cells) in samples of liver tissue taken during elective liver surgery. Outcomes based on 3 measures will test the hypothesis that Resveratrol when used as a nutritional supplement will 1)improve metabolic function in liver cells, 2)reduce cellular growth and proliferation of cancer cells, 3)decrease inflammation in the liver.
详细描述
Hepatic function will be assessed by standard laboratory techniques. Hepatocyte signaling pathway proteins will be measured using western blot analysis for protein expression and polymerase chain reaction for gene expression. Activation of signaling pathways in both native hepatocytes and carcinoma will be analyzed by multi-plex signal array. The effect on transcription factors that may be important in gene expression will be analyzed by transcription factor array. The effect of resveratrol in altering hepatocyte and cancer cell metabolism will be analyzed by proteomic analysis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 21 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Undergoing elective liver resection for liver cancer
排除标准
- •Inability to speak or read English
- •Sclerosing cholangitis, hemochromatosis, hepatic encephalopathy, acute hepatic failure
- •History of daily alcohol intake
- •Presence of human immunodeficiency virus
- •Presence of significant renal dysfunction as defined by baseline serum creatinine > 2.0 mg/dl or need/impending need for chronic dialysis therapy
- •Known allergy to the study medication
- •Pregnancy, lactating women, women contemplating pregnancy during the study period
研究组 & 干预措施
resveratrol
Resveratrol 1 g daily for 10 days
干预措施: Resveratrol (Dietary Supplement)
Placebo
Placebo 1 pill daily for 10 days
干预措施: Placebo (Drug)
结局指标
主要结局
Improved metabolic profile of liver cells
时间窗: 36 months
This outcome is a composite outcome and will be measured by assessing expression of multiple signaling proteins that are important in hepatic cell metabolism such as Akt, p38, Mitogen Activated Kinases, and Adenosine Monophosphate-activated Kinase (AMPK) and expression of gluconeogenic proteins such as Phosphoenolpyruvate carboxykinase (PEPCK).
次要结局
- Decreased hepatic inflammation(36 months)
- Decreased cell growth and proliferation(36 months)
研究者
Brian G. Harbrecht
MD
University of Louisville