title: No evidence of hypoglycemia or hypotension in older adults during 6 months of flax lignan supplementation in a randomized controlled trial: a safety evaluation.
abstract: BACKGROUND
  The natural health product, BeneFlax, is a standardized flaxseed [Linum usitatissimum L. (Linaceae)] lignan enriched product with evidence of product quality and known quantity of the bioactive component, lignan. The acceptance of this natural health product for its various health benefits requires greater evidence of its safety in the general population.
  
  
  OBJECTIVE
  We determined whether flaxseed lignan causes clinical hypoglycemia or hypotension in healthy older adults as an important aspect of safety.
  
  
  METHODS
  Participants aged 49-87 years were randomized in a double-blind trial to receive flaxseed lignan (543 mg/day in BeneFlax) or placebo while completing a 6-month walking program. The 94 participants who completed the study were stratified by age (<65 years versus ≥65 years) and treatment category to determine whether older adults were more susceptible to adverse effects.
  
  
  RESULTS
  After 6 months of treatment, average plasma glucose level (5.4 ± 0.6 mmol/L), systolic blood pressure (127 ± 14 mm Hg), and diastolic blood pressure (80 ± 9 mm Hg) were within normal clinical range. Controlling for sex and body mass index covariates resulted in no observed differences between plasma glucose or blood pressure measurements between treatment or age groups (p > 0.05). No incidents of hypoglycemia or hypotension were observed during BeneFlax treatment, suggesting that 543 mg falls at or below the no observable adverse effect level (NOAEL).
  
  
  CONCLUSIONS
  These data suggest the flaxseed lignan product BeneFlax does not pose a risk of hypoglycemia or hypotension in healthy adults aged 49-87 years.
authors.affiliation: College of Pharmacy & Nutrition, University of Saskatchewan, Saskatoon, Canada S7N 5C9.
authors.forename: Jennifer
authors.initials: J
authors.lastname: Billinsky
authors.forename: Riley A
authors.initials: RA
authors.lastname: Glew
authors.forename: Stephen M
authors.initials: SM
authors.lastname: Cornish
authors.forename: Susan J
authors.initials: SJ
authors.lastname: Whiting
authors.forename: Lilian U
authors.initials: LU
authors.lastname: Thorpe
authors.forename: Jane
authors.initials: J
authors.lastname: Alcorn
authors.forename: Lisa
authors.initials: L
authors.lastname: Paus-Jenssen
authors.forename: Thomas
authors.initials: T
authors.lastname: Hadjistavropoulos
authors.forename: Philip D
authors.initials: PD
authors.lastname: Chilibeck
mesh_terms: D000367:Age Factors; D000368:Aged; D000369:Aged, 80 and over; D001786:Blood Glucose / Q000187:drug effects; D001794:Blood Pressure / Q000187:drug effects; D019587:Dietary Supplements / Q000009:adverse effects*; D004311:Double-Blind Method; D005260:Female; D019597:Flax / Q000009:adverse effects*; D006801:Humans; D007003:Hypoglycemia / Q000453:epidemiology; D007022:Hypotension / Q000453:epidemiology; D017705:Lignans / Q000008:administration & dosage / Q000009:adverse effects*; D008297:Male; D008875:Middle Aged; D019055:No-Observed-Adverse-Effect Level
chemical_list: D001786:Blood Glucose; D017705:Lignans