title: Effect of alpha linolenic acid supplementation on serum prostate specific antigen (PSA): results from the alpha omega trial.
abstract: BACKGROUND
  Alpha linolenic acid (ALA) is the major omega-3 fatty acid in the diet. Evidence on health effects of ALA is not conclusive, but some observational studies found an increased risk of prostate cancer with higher intake of ALA. We examined the effect of ALA supplementation on serum concentrations of prostate-specific antigen (PSA), a biomarker for prostate cancer.
  
  
  METHODS
  The Alpha Omega Trial (ClinicalTrials.gov Identifier: NCT00127452) was a double-blind, placebo-controlled trial of ALA and the fish fatty acids eicosapentanoic acid (EPA) and docosahexanoic acid (DHA) on the recurrence of cardiovascular disease, using a 2×2 factorial design. Blood was collected at the start and the end of the intervention period. The present analysis included 1622 patients with a history of a myocardial infarction, aged 60-80 years with an initial PSA concentration <4 ng/mL. They received either 2 g per day of ALA or placebo in margarine spreads for 40 months. T-tests and logistic regression were used to assess the effects of ALA supplementation on changes in serum PSA (both continuously and as a dichotomous outcome, cut-off point: >4 ng/mL).
  
  
  RESULTS
  Mean serum PSA increased by 0.42 ng/mL on placebo (n = 815) and by 0.52 ng/mL on ALA (n = 807), a difference of 0.10 (95% confidence interval: -0.02 to 0.22) ng/mL (P = 0·12). The odds ratio for PSA rising above 4 ng/mL on ALA versus placebo was 1.15 (95% CI: 0.84-1.58).
  
  
  CONCLUSIONS
  An additional amount of 2 g of ALA per day increased PSA by 0.10 ng/mL, but the confidence interval ranged from -0.02 to 0.22 ng/mL and included no effect. Therefore, more studies are needed to establish whether or not ALA intake has a clinically significant effect on PSA or prostate cancer.
  ClinicalTrials.gov; Identifier: NCT00127452. URL: http://www.clinicaltrials.gov/ct2/show/NCT00127452.
authors.affiliation: Department of Health Sciences and the EMGO+ Institute for Health and Care Research, Faculty of Earth and Life Sciences, VU University Amsterdam, Amsterdam, The Netherlands.
authors.forename: Ingeborg A
authors.initials: IA
authors.lastname: Brouwer
authors.affiliation: Division of Human Nutrition, Wageningen University, Wageningen, The Netherlands.
authors.forename: Johanna M
authors.initials: JM
authors.lastname: Geleijnse
authors.affiliation: Department of Health Sciences and the EMGO+ Institute for Health and Care Research, Faculty of Earth and Life Sciences, VU University Amsterdam, Amsterdam, The Netherlands ; Division of Human Nutrition, Wageningen University, Wageningen, The Netherlands.
authors.forename: Veronique M
authors.initials: VM
authors.lastname: Klaasen
authors.affiliation: Department of Health Sciences and the EMGO+ Institute for Health and Care Research, Faculty of Earth and Life Sciences, VU University Amsterdam, Amsterdam, The Netherlands.
authors.forename: Liesbeth A
authors.initials: LA
authors.lastname: Smit
authors.affiliation: Department of Psychiatry, Leiden University Medical Center, Leiden, The Netherlands.
authors.forename: Erik J
authors.initials: EJ
authors.lastname: Giltay
authors.affiliation: Division of Human Nutrition, Wageningen University, Wageningen, The Netherlands.
authors.forename: Janette
authors.initials: J
authors.lastname: de Goede
authors.affiliation: Endocrine Laboratory, Department of Clinical Chemistry, VU University Medical Center, Amsterdam, The Netherlands.
authors.forename: Annemieke C
authors.initials: AC
authors.lastname: Heijboer
authors.affiliation: Division of Human Nutrition, Wageningen University, Wageningen, The Netherlands.
authors.forename: Daan
authors.initials: D
authors.lastname: Kromhout
authors.affiliation: Department of Health Sciences and the EMGO+ Institute for Health and Care Research, Faculty of Earth and Life Sciences, VU University Amsterdam, Amsterdam, The Netherlands.
authors.forename: Martijn B
authors.initials: MB
authors.lastname: Katan
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D019587:Dietary Supplements; D004281:Docosahexaenoic Acids / Q000008:administration & dosage; D004311:Double-Blind Method; D015118:Eicosapentaenoic Acid / Q000008:administration & dosage; D006801:Humans; D016015:Logistic Models; D008297:Male; D008383:Margarine; D008875:Middle Aged; D009203:Myocardial Infarction / Q000503:physiopathology; D011467:Prostate / Q000187:drug effects* / Q000378:metabolism; D017430:Prostate-Specific Antigen / Q000097:blood*; D017962:alpha-Linolenic Acid / Q000008:administration & dosage*
chemical_list: D017962:alpha-Linolenic Acid; D004281:Docosahexaenoic Acids; D008383:Margarine; D015118:Eicosapentaenoic Acid; D017430:Prostate-Specific Antigen