Does Protein Restriction Inhibit Prostrate Cancer Growth
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|ClinicalTrials.gov Identifier: NCT01692587|
Recruitment Status : Completed
First Posted : September 25, 2012
Last Update Posted : October 9, 2018
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.
|Condition or disease||Intervention/treatment||Phase|
|Prostate Cancer||Other: Protein restrictive diet||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||65 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Basic Science|
|Official Title:||Does Protein Restriction Inhibit Prostrate Cancer Growth|
|Actual Study Start Date :||January 2011|
|Actual Primary Completion Date :||March 2015|
|Actual Study Completion Date :||March 2015|
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
- 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) ]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.
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): NCT01692587
|United States, Missouri|
|Washington University School of Medicine|
|Saint Louis, Missouri, United States, 63110|
|Principal Investigator:||Luigi Fontana, MD,PhD||Washington University School of Medicine|