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.|
|ClinicalTrials.gov Identifier: NCT02261844|
Recruitment Status : Withdrawn (No funding)
First Posted : October 10, 2014
Last Update Posted : March 30, 2017
|Condition or disease||Intervention/treatment||Phase|
|Liver Cancer||Dietary Supplement: Resveratrol Drug: Placebo||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Intervention Model:||Parallel Assignment|
|Primary Purpose:||Basic Science|
|Official Title:||Resveratrol and Human Hepatocyte Function in Cancer|
|Study Start Date :||December 2015|
|Estimated Primary Completion Date :||June 2016|
|Study Completion Date :||June 2016|
Resveratrol 1 g daily for 10 days
Dietary Supplement: Resveratrol
Resveratrol 1 gm po x 10 days prior to liver resection
Other Name: Biotivia
Placebo Comparator: Placebo
Placebo 1 pill daily for 10 days
Placebo 1 pill daily X 10 days
- 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).
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02261844
|United States, Kentucky|
|University of Louisville|
|Louisville, Kentucky, United States, 40202|
|Principal Investigator:||Brian G Harbrecht, MD||University of Louisville|