title: The COFU3 Study. Improvement in cognitive function, attention, mental performance with Pycnogenol® in healthy subjects (55-70) with high oxidative stress.
abstract: OBJECTIVE
  This 12-month product registry study evaluated the effects of supplementation with French pine bark extract (Pycnogenol(®)) on cognitive function, attention, and mental performance in healthy subjects with high oxidative stress.
  
  
  METHODS
  Healthy subjects (age range 55-70) were screened - within a cardiovascular screening program - for oxidative stress. Out of 150 subjects, high oxidative stress was present in 44; the use of the supplement Pycnogenol(®) was suggested (100 mg/day). These subjects decided to use Pycnogenol(®) and accepted to be evaluated by assessing cognitive functions. A group of subjects with comparable oxidative stress was followed as a reference. IQ Code (Informant Questionnaire on Cognitive Decline in the Elderly), daily tasks, cognitive function, oxidative stress and the short Blessed tests (SBT) were used (in defined scales) to evaluate cognitive functions (COFU).
  
  
  RESULTS
  As for the IQ Code, at 12 months there was a significantlty total lower score in Pycnogenol(®) patients and also a lower value (P<0.05) for 14 out of 16 items in the questionnaire. Daily tasks: all items were improved (P<0.05) with supplementation in comparison with controls. The improvement was seen for all 12 items (P<0.05) with the supplement. Cognitive function values (visual scale line) indicated a significant improvement (P<0.05) in all elements present in the questionnaire with the 12-month supplementation (no significant variations in controls). Oxidative stress was comparable in both groups at inclusion. It was significantly decreased with Pycnogenol(®) (-28.07%; P<0.05) at 12 months; there was no decrease in controls. The short blessed test (SBT) value was significantly increased in controls (P<0.05); but significantly decreased in the Pycnogenol(®) group (P<0.05). Values for supplemented patients at 12 months were almost within the normal range (21 out or 38 were below the normal value of 4). Tolerability and compliance for Pycnogenol(®) were optimal with >97% of the doses of the supplement correctly used. No side effects were observed, recorded or described.
  
  
  CONCLUSIONS
  Pycnogenol(®) supplementation for 12 months appears to improve cognitive function and oxidative stress in normal subjects between 55 and 70 years of age.
authors.affiliation: Irvine3 Labs, Department of Biomedical Sciences, Chieti-Pescara University, Pescara, Italy - cardres@abol.it.
authors.forename: G
authors.initials: G
authors.lastname: Belcaro
authors.forename: M
authors.initials: M
authors.lastname: Dugall
authors.forename: E
authors.initials: E
authors.lastname: Ippolito
authors.forename: S
authors.initials: S
authors.lastname: Hu
authors.forename: A
authors.initials: A
authors.lastname: Saggino
authors.forename: B
authors.initials: B
authors.lastname: Feragalli
mesh_terms: D000276:Adjuvants, Immunologic / Q000627:therapeutic use; D000368:Aged; D001288:Attention / Q000187:drug effects*; D003071:Cognition / Q000187:drug effects*; D019587:Dietary Supplements; D005260:Female; D005419:Flavonoids / Q000627:therapeutic use*; D005609:Free Radicals / Q000097:blood*; D064368:Healthy Volunteers; D006801:Humans; D008297:Male; D008875:Middle Aged; D009483:Neuropsychological Tests; D018384:Oxidative Stress / Q000187:drug effects*; D010936:Plant Extracts; D012042:Registries
chemical_list: D000276:Adjuvants, Immunologic; D005419:Flavonoids; D005609:Free Radicals; D010936:Plant Extracts; C024070:pycnogenols