Clinical Trials Directory

Trials / Completed

CompletedNCT00433797

Dietary Intervention With Phytochemicals and Polyunsaturated Fatty Acids in Prostate Cancer Patients

Prostate Phytochemical & PUFA Intervention - a Phase I/II Study

Status
Completed
Phase
Phase 1 / Phase 2
Study type
Interventional
Enrollment
86 (actual)
Sponsor
University of Oslo · Academic / Other
Sex
Male
Age
Healthy volunteers
Not accepted

Summary

We will study the effect of dietary intervention in patients with prostate cancer. Outcomes include serum PSA kinetics, as well as biomarkers of inflammation, antioxidant status, oxidative stress and oxidative damage in blood cells, plasma, urine and prostate tissues

Detailed description

A total of 102 patients with localized prostate cancer will be included in the study. A the time of inclusion, the participants will be randomized to three groups. The intervention groups includes; control group, tomato group and multi-diet group. The intervention period is three week and will be completed before prostatectomy or radiation therapy. Biomarkers og inflammation includes: acute phase proteins, cytokines, chemokines and other inflammatory mediators. Biomarker of antioxidant status includes vitamin C, vitamin E, glutathione, carotenoids, total antioxidant capacity and total phenolics. Oxidative stress markers includes; malondialdehyde, isoprostanes, 8-hydroxy-deoxyguanosine, oxidized vitamin C, total lipidperoxides (d-ROM) and protein carbonyls.

Conditions

Interventions

TypeNameDescription
DIETARY_SUPPLEMENTProstate cancer, phytochemical and PUFAPatients with localized prostate cancer are supplemented with either tomato or a multi-diet cinsisting of grape juice, pomegranate juice, tomato, green tea, black tea, soy, selenium and PUFAs for 3 weeks.

Timeline

Start date
2007-06-01
Primary completion
2012-03-01
Completion
2013-12-01
First posted
2007-02-12
Last updated
2013-12-19

Locations

1 site across 1 country: Norway

Source: ClinicalTrials.gov record NCT00433797. Inclusion in this directory is not an endorsement.