Does Protein Restriction Inhibit Prostrate Cancer Growth
The Purpose of the Protein Study is to investigate whether a reduced protein diet can inhibit the growth of prostate cancer in humans.
The Investigators hypothesis is that a reduced protein diet will inhibit expression of genes that are involved in the growth of prostate cancer.
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Basic Science
|Official Title:||Does Protein Restriction Inhibit Prostrate Cancer Growth|
- Group1--Expression of genes and proteins of the PI-3K/Akt/mTOR pathway. Group 2--PSA values obtained every three months [ Time Frame: group 1- (4-6 weeks), group 2 -(52 weeks) ] [ Designated as safety issue: No ]The investigators will be looking at the increase or decrease of PSA values between control and protein restricted diet participants obtained for the length of study.
|Study Start Date:||January 2011|
|Estimated Study Completion Date:||April 2015|
|Estimated Primary Completion Date:||April 2015 (Final data collection date for primary outcome measure)|
No Intervention: Control
No changes in dietary group
Experimental: Protein restrictive diet
reduced protein diet
Other: Protein restrictive diet
To begin a reduced protein diet
The primary objective of this study is to determine whether or not a low protein diet has an inhibitory effect on prostate cancer cell growth.
The primary outcome measures relative to the investigators primary objectives are:
For Group 1 the expression of genes and proteins of the PI-3K/Akt/mTOR pathway. For Group 2 the PSA values obtained every three months.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01692587
|United States, Missouri|
|Washington University School of Medicine|
|St. Louis, Missouri, United States, 63110|
|Principal Investigator:||Luigi Fontana, MD,PhD||Washington University School of Medicine|