C61
Conditions
Interventions
Group 1: Patients supplemented with omega-3 fatty acids (Vitalipin, marine phospholipids). Dose: 3 x 500mg per day during 3 months.
Group 2: Healthy subject supplemented with omega-3 fatty acids (Vita
Sponsors
Klinik für Tumorbiologie
Eligibility
Sex/Gender
Male
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Patient inclusion criteria: - Patients with histologically proven prostate cancer who are treated or advised in one of the centers involved in the study - Written informed consent Inclusion criteria for healthy subjects: - Subjects without prostate cancer or any other tumor, which are screened in one of the study centers and are 70 years or older. - Exclusion of prostate cancer according to one of the following criteria: * Men with a PSA level of maximum 10 ng/ml, who underwent a 12x punch biopsy with a negative result. * Men with benign prostatic hyperplasia (BPH), in whom a transurethral resection of the prostate (TUR-P) was conducted and the histology of the recovered material was negative (PSA maximum 10 ng /l). * PSA less than 4ng/l and no prostate cancer family history - Written informed consent
Exclusion criteria
Exclusion criteria: - Patients / healthy subjects with a known allergy to seafood - Patients / healthy subjects who can not eat or are on a special diet - Patients / healthy subjects with malabsorption (i.e. after gastrointestinal surgery, inflammatory bowel disease) - Patients / healthy subjects with severe internal diseases, especially with impaired coagulation, liver or gall bladder disease, bile duct tumors, or pancreatitis - Patients / healthy subjects who are already taking omega-3 fatty acids supplementation or other dietary supplements and drugs that are likely to affect the results of the research - Patients / healths subjects with psychiatric or CNS disorders, who are not able to consent to participation in the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Analysis of polymorphisms (SNPs) in genes of the fatty acid metabolism will be done to each patient / healthy subject at the beginning of the study. | — |
Secondary
| Measure | Time frame |
|---|---|
| To assess changes in the fatty acid composition in plasma after the supplementation with the omega-3-preparation and its relation to the found SNP. Phospholipids, lysolipids and their fatty acid composition in plasma at baseline and after three months of omega-3-intake will be analyzed. | — |
Countries
Germany
Contacts
Public ContactDaniela Küllenberg
Klinik für Tumorbiologie
Outcome results
None listed