Low-Fat Diet and Omega-Fatty Acids for Prostate Cancer Prevention

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2009 by University of California, Los Angeles.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
Information provided by:
University of California, Los Angeles
ClinicalTrials.gov Identifier:
NCT00836615
First received: February 3, 2009
Last updated: February 10, 2011
Last verified: February 2009

February 3, 2009
February 10, 2011
January 2006
December 2011   (final data collection date for primary outcome measure)
fat acid ratio [ Time Frame: 3 months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00836615 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Low-Fat Diet and Omega-Fatty Acids for Prostate Cancer Prevention
Low-Fat Diet and Omega-Fatty Acids for Prostate Cancer Prevention

Men who are scheduled for radical prostatectomy are considered candidates for this study. Six weeks prior to surgery, the subject will undergo screening procedures to determine eligibility. If eligible, the subject will be randomized to one of two four-week nutrition programs - either a balanced Western Diet or a low-fat diet with fish oil capsules. The UCLA GCRC (General Clinical Research Center) chefs will prepare breakfast, lunch, and dinner, and meals will be delivered to subjects in coolers two days per week. Subjects will require a minimum of four visits to the UCLA GCRC.

Experiments have shown that a low fat diet high in fish oil may prevent the progression of prostate cancer. The purpose of this study is to determine if a low-fat diet combined with fish oil capsules will change the chemical substances present in blood and prostate tissue that are related to the growth of cancer cells. This study will compare how these substances are affected by either, a typical high-fat Western diet, or a low-fat diet combined with fish oil.

Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Prostate Cancer
  • Dietary Supplement: Western Diet
    Western diet (prepared by General Clinical Research Center) received 2 to 3 times per week for 4 weeks.
    Other Name: Diet created by General Clinical Research Center.
  • Dietary Supplement: Low-fat diet
    Low-fat diet with fish oil capsules (prepared by General Clinical Research Center) received 2 to 3 times per week for 4 weeks.
    Other Name: Fish oil capsules: 1 g by Pharmavite Inc, Mission Hills, CA
  • Experimental: Western Diet
    Subjects assigned to this arm will receive a western diet which will be prepared by UCLA's General Clinical Research Center and delivered 2 to 3 times per week.
    Intervention: Dietary Supplement: Western Diet
  • Experimental: Low-fat diet
    A low-fat diet with fish oil capsules will be assigned to patients which will be prepared by General Clinical Research Center and delivered 2 to 3 times per week. In addition, this group will be asked to take 5 fish oil capsules per day.
    Intervention: Dietary Supplement: Low-fat diet
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
70
December 2011
December 2011   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Has been diagnosed with adenocarcinoma (cancer)
  • Able to sign the consents to participate.
  • Is medically able to receive and comply with the dietary intervention.
  • Accessible geographically and by telephone for nutritional counseling and follow up.
  • Has elected to undergo radical prostatectomy.
  • Agrees to stop taking dietary or vitamin supplements (Lycopene, Vitamin E, selenium, genistein) or herbal supplements (eg. saw palmetto, PC-SPES) for 1 week prior to starting the study.
  • Can safely stop taking aspirin, COX-2 inhibitors, and other anti-inflammatory medications for 1 week prior to starting the study.
  • Can safely stop taking fish oil capsules 2-weeks prior to starting the diet intervention.

Exclusion Criteria:

  • Is taking LHRH agonists, androgen receptor blocking agents or finasteride.
  • Has undergone bilateral orchiectomy.
  • Has a bleeding disorder.
Male
40 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00836615
01-07-026-21, P50CA092131-01A1
Yes
William Aronson, MD, University of California, Los Angeles
University of California, Los Angeles
National Cancer Institute (NCI)
Principal Investigator: William Aronson, MD University of California, Los Angeles
University of California, Los Angeles
February 2009

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