Resveratrol and Human Hepatocyte Function in Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02261844
Recruitment Status : Withdrawn (No funding)
First Posted : October 10, 2014
Last Update Posted : March 30, 2017
Information provided by (Responsible Party):
Brian G. Harbrecht, University of Louisville

May 20, 2014
October 10, 2014
March 30, 2017
December 2015
June 2016   (Final data collection date for primary outcome measure)
Improved metabolic profile of liver cells [ Time Frame: 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).
Same as current
Complete list of historical versions of study NCT02261844 on Archive Site
  • Decreased cell growth and proliferation [ Time Frame: 36 months ]
    This outcome is a composite outcome of cellular pathways important in cancer cell replication. This will be measured by the expression of genes and proteins that regulate hepatic cell growth/cell survival such as cyclin gene expression, expression of the tumor suppressor p53, and expression of apoptosis proteins Bcl-2 and Bcl-xl.
  • Decreased hepatic inflammation [ Time Frame: 36 months ]
    This outcome will be a composite outcome of pathways that regulate both cancer cell growth and inflammation. It will be measured by levels of genes and proteins for nitric oxide synthase, cytokines such as interleukin-6, and Nuclear Factor-kappa B signaling proteins.
Same as current
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Resveratrol and Human Hepatocyte Function in Cancer
Resveratrol and Human Hepatocyte Function in Cancer
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.
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.
Phase 1
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Basic Science
Liver Cancer
  • Dietary Supplement: Resveratrol
    Resveratrol 1 gm po x 10 days prior to liver resection
    Other Name: Biotivia
  • Drug: Placebo
    Placebo 1 pill daily X 10 days
  • Experimental: resveratrol
    Resveratrol 1 g daily for 10 days
    Intervention: Dietary Supplement: Resveratrol
  • Placebo Comparator: Placebo
    Placebo 1 pill daily for 10 days
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
June 2016
June 2016   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
21 Years to 80 Years   (Adult, Older Adult)
Contact information is only displayed when the study is recruiting subjects
United States
Not Provided
Not Provided
Brian G. Harbrecht, University of Louisville
University of Louisville
Not Provided
Principal Investigator: Brian G Harbrecht, MD University of Louisville
University of Louisville
March 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP