title: Safety of phosphatidylserine containing omega-3 fatty acids in non-demented elderly: a double-blind placebo-controlled trial followed by an open-label extension.
abstract: BACKGROUND
  Phosphatidylserine (PS) is a naturally occurring phospholipid present in the inner leaflet of mammalian plasma membranes. Administration of PS extracted from bovine cortex (BC-PS), which contains high levels of omega-3 long chain polyunsaturated fatty acid (LC-PUFA) attached to its backbone, resulted in positive effects on brain functions such as learning and memory. Recently, a novel marine-sourced PS with omega-3 LC-PUFA attached to its backbone was developed (PS-DHA). In the present study, we evaluated the safety profile of the novel PS preparation in non-demented elderly with memory complaints. The efficacy study of this novel formulation indicated that PS-DHA may ameliorate cognitive deficits in non-demented elderly population.
  
  
  METHODS
  157 non-demented elderly participants with memory complaints were randomized to receive either PS-DHA (300 mg PS/day) or placebo for 15 weeks. Standard biochemical and hematological safety parameters, blood pressure and heart rate were evaluated at baseline and endpoint. 122 participants continued into an open-label extension for additional 15 weeks, in which they all consumed PS-DHA (100 mg PS/day) and were evaluated for their blood pressure, heart rate and weight at endpoint. Adverse events were monitored throughout the double-blind and open-label phases.
  
  
  RESULTS
  131 participants completed the double-blind phase. No significant differences were found in any of the tested safety parameters between the study groups, or within each group. 121 participants completed the open-label phase. At the end of this phase, there was a reduction in resting diastolic blood pressure and a slight weight gain among participants who consumed PS-DHA for 30 weeks.
  
  
  CONCLUSIONS
  The results of this study indicate that consumption of PS-DHA at a dosage of 300 mg PS/day for 15 weeks, or 100 mg PS/day for 30 weeks, is safe, well tolerated, and does not produce any negative effects in the tested parameters.
  
  
  BACKGROUND
  clinicaltrials. gov, identifier: NCT00437983.
authors.affiliation: Sieratzki Chair of Neurology, Tel-Aviv University Medical School, Ramat Aviv, Israel.
authors.forename: Veronika
authors.initials: V
authors.lastname: Vakhapova
authors.forename: Yael
authors.initials: Y
authors.lastname: Richter
authors.forename: Tzafra
authors.initials: T
authors.lastname: Cohen
authors.forename: Yael
authors.initials: Y
authors.lastname: Herzog
authors.forename: Amos D
authors.initials: AD
authors.lastname: Korczyn
mesh_terms: D001769:Blood / Q000187:drug effects; D001794:Blood Pressure / Q000187:drug effects*; D001835:Body Weight / Q000187:drug effects*; D004311:Double-Blind Method; D015525:Fatty Acids, Omega-3 / Q000009:adverse effects*; D005260:Female; D006339:Heart Rate / Q000187:drug effects*; D006801:Humans; D008297:Male; D010718:Phosphatidylserines / Q000009:adverse effects*
chemical_list: D015525:Fatty Acids, Omega-3; D010718:Phosphatidylserines