Low-Fat Fish Oil Diet for Prostate Cancer Prevention - Full Text View

Sponsor:	University of California, Los Angeles
Collaborator:	National Cancer Institute (NCI)
Information provided by:	University of California, Los Angeles
ClinicalTrials.gov Identifier:	NCT00798876

Sponsor:

University of California, Los Angeles

Collaborator:

National Cancer Institute (NCI)

Information provided by:

University of California, Los Angeles

ClinicalTrials.gov Identifier:

NCT00798876

Purpose

Studies on patterns of how many men get prostate cancer in other countries show that environment contributes to the high incidence of prostate cancer in the United States. Epidemiology studies suggest that this influence may be reduced by the diet of men at risk of getting prostate cancer. Although the exact nature of the effects of diet are not completely known, the amount of fat eaten appears to affect the number of men who get prostate cancer. The type of fat also seems to matter. Eating more of a type of fat called omega-3 polyunsaturated fat is associated with decreased prostate cancer risk. Omega-3 fat comes from fish and is quite different from the type of fat from animals and vegetables (omega-6 fat). Because the exact mechanism of this reduction in prostate cancer risk is not known, no blood test indications, called markers, have been discovered that would show the effect working.

Study doctors designed this study to try to find markers in the blood tests of men who have prostate cancer, and to find out if a diet supplemented with omega-3 type fat from fish oil helps reduce those markers, hence indicating that it helps reduce the cancer in these men. These men will be compared to men with prostate cancer whose diets do not contain the fish-oil fat.

The men chosen will have prostate cancer and be scheduled for operations to have their prostate glands removed. They will be chosen randomly to be given the fish-oil diet or a regular Western diet for comparison for 4 to 8 weeks. Their blood will be checked at the beginning of the diet. After the 4-to-8-week period, they will have their operations. Their blood will be checked again and a sample of their removed prostate will be examined to tell if the diet had any effect on the cancer and its markers.

Condition	Intervention
Prostate Cancer	Dietary Supplement: Fish Oil Dietary Supplement: Vitamin E supplement Dietary Supplement: Western Diet Dietary Supplement: Low-Fat Diet Other: Medical Examination Other: Dietary Interview Other: Blood Draw Procedure: Radical Prostatectomy

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Pharmacokinetics/Dynamics Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Diagnostic
Official Title:	Comparison Study of a Low-Fat Diet Supplemented With Fish Oil and a Standard Western Diet in Individuals With Prostate Cancer

Resource links provided by NLM:

MedlinePlus related topics: Cancer Diabetes Medicines Dietary Supplements Prostate Cancer Vitamin E

Drug Information available for: alpha-Tocopherol DL-alpha-Tocopherol Vitamin E Tocopherols Tocotrienol Fish oil

U.S. FDA Resources

Further study details as provided by University of California, Los Angeles:

Primary Outcome Measures:

check for insulin growth factor-1 (IGF-1) and insulin growth factor binding proteins (IGFBP) as relevant intermediate biomarkers for prostate cancer [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Check serum and tissue fatty acids as relevant intermediate biomarkers for prostate cancer [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment:	70
Study Start Date:	December 2001
Estimated Primary Completion Date:	August 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Placebo Comparator: Standard Western Diet Subjects will be asked to consume a standard Western Diet for 4 weeks. For the 4-week period, subjects will be provided with all food and beverages. Subjects will also undergo a medical examination, dietary interview, blood draw, and radical prostatectomy(as part of standard of care).	Dietary Supplement: Western Diet Subjects will be provided with a standard western diet, food and beverages, to consume during their 4 week participation in this study. Other: Medical Examination Subjects will have a routine medical exam. Other: Dietary Interview Subjects will meet with the study nutritionist and have their current diet evaluated. Subjects will also undergo a test (bioimpedance) to estimate their body fat, lean weight, and the rate at which their body burns fat. Other: Blood Draw 40 mL of blood will be drawn from subjects to measure PSA, fatty acids, insulin and various hormones. Procedure: Radical Prostatectomy Subjects will undergo a radical prostatectomy as part of their standard of care.
Experimental: Low-Fat Diet Subjects will be asked to consume a low fat diet with fish oil and vitamin E supplements for 4 weeks. For the 4-week period, subjects will be provided with all food and beverages. Subjects will also undergo a medical examination, dietary interview, blood draw, and radical prostatectomy(as part of standard of care).	Dietary Supplement: Fish Oil Subjects will be asked to take 10 grams of fish oil per day for 4 weeks. Dietary Supplement: Vitamin E supplement Subjects will be asked to take 800 International Units per day of Vitamin E for 4 weeks. Dietary Supplement: Low-Fat Diet Subjects will be provided with a low-fat diet (food and beverages) for their 4 week participation in this study. Other: Medical Examination Subjects will have a routine medical exam. Other: Dietary Interview Subjects will meet with the study nutritionist and have their current diet evaluated. Subjects will also undergo a test (bioimpedance) to estimate their body fat, lean weight, and the rate at which their body burns fat. Other: Blood Draw 40 mL of blood will be drawn from subjects to measure PSA, fatty acids, insulin and various hormones. Procedure: Radical Prostatectomy Subjects will undergo a radical prostatectomy as part of their standard of care.

Arms

Assigned Interventions

Placebo Comparator: Standard Western Diet

Subjects will be asked to consume a standard Western Diet for 4 weeks. For the 4-week period, subjects will be provided with all food and beverages. Subjects will also undergo a medical examination, dietary interview, blood draw, and radical prostatectomy(as part of standard of care).

Dietary Supplement: Western Diet

Subjects will be provided with a standard western diet, food and beverages, to consume during their 4 week participation in this study.

Other: Medical Examination

Subjects will have a routine medical exam.

Other: Dietary Interview

Subjects will meet with the study nutritionist and have their current diet evaluated. Subjects will also undergo a test (bioimpedance) to estimate their body fat, lean weight, and the rate at which their body burns fat.

Other: Blood Draw

40 mL of blood will be drawn from subjects to measure PSA, fatty acids, insulin and various hormones.

Procedure: Radical Prostatectomy

Subjects will undergo a radical prostatectomy as part of their standard of care.

Experimental: Low-Fat Diet

Subjects will be asked to consume a low fat diet with fish oil and vitamin E supplements for 4 weeks. For the 4-week period, subjects will be provided with all food and beverages. Subjects will also undergo a medical examination, dietary interview, blood draw, and radical prostatectomy(as part of standard of care).

Dietary Supplement: Fish Oil

Subjects will be asked to take 10 grams of fish oil per day for 4 weeks.

Dietary Supplement: Vitamin E supplement

Subjects will be asked to take 800 International Units per day of Vitamin E for 4 weeks.

Dietary Supplement: Low-Fat Diet

Subjects will be provided with a low-fat diet (food and beverages) for their 4 week participation in this study.