Resveratrol and Human Hepatocyte Function in Cancer
Conditions
Liver Cancer
Conditions: Keywords
Hepatocellular carcinoma, Metastatic colorectal cancer, Metabolism, Hepatic function
Study Type
Interventional
Study Phase
Phase 1/Phase 2
Study Design
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Basic Science
Intervention
Name: Resveratrol Type: Dietary Supplement
Name: Placebo Type: Drug
Overall Status
Not yet recruiting
Summary
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.
Detailed Description
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.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: 80 Years
Minimum Age: 21 Years
Gender: Both
Criteria: Inclusion Criteria:

- Undergoing elective liver resection for liver cancer

Exclusion Criteria:

- 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
Location
University of Louisville
Louisville, Kentucky, United States
Status: Not yet recruiting
Contact: Brian G Harbrecht, MD - 502-852-5675 - briang.harbrecht@louisville.edu
Start Date
December 2015
Completion Date
July 2017
Sponsors
University of Louisville
Source
University of Louisville
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page