Belcaro G, Dugall M, Ippolito E, Hu S, Saggino A, Feragalli B
Irvine3 Labs, Department of Biomedical Sciences, Chieti-Pescara University, Pescara, Italy -
J Neurosurg Sci. 2015 Dec;59(4):437-46.
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.
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).
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.
Pycnogenol(®) supplementation for 12 months appears to improve cognitive function and oxidative stress in normal subjects between 55 and 70 years of age.
这项为期12个月的产品注册研究评估了补充法国松树皮提取物(碧萝芷(®))对氧化应激水平较高的健康受试者认知功能、注意力和心理表现的影响。
在一项心血管筛查项目中,对健康受试者(年龄范围55 - 70岁)进行氧化应激筛查。150名受试者中,44人存在高氧化应激;建议他们使用补充剂碧萝芷(®)(100毫克/天)。这些受试者决定使用碧萝芷(®)并接受通过评估认知功能进行的评估。一组具有可比氧化应激水平的受试者作为对照。使用IQ Code(老年人认知能力下降知情者问卷)、日常任务、认知功能、氧化应激和简短Blessed测试(SBT)(在规定量表中)来评估认知功能(COFU)。
关于IQ Code,在12个月时,服用碧萝芷(®)的患者总分显著更低,问卷中16项中的14项得分也更低(P<0.05)。日常任务:与对照组相比,补充剂使所有项目均有改善(P<0.05)。补充剂对所有12项均有改善(P<0.05)。认知功能值(视觉量表线)表明,12个月的补充剂服用使问卷中所有项目均有显著改善(对照组无显著变化)。两组纳入时氧化应激水平相当。12个月时,碧萝芷(®)使其显著降低(-28.07%;P<0.05);对照组无降低。简短Blessed测试(SBT)值在对照组中显著升高(P<0.05);但在碧萝芷(®)组中显著降低(P<0.05)。服用补充剂的患者在12个月时的值几乎在正常范围内(38项中有21项低于正常值4)。碧萝芷(®)的耐受性和依从性最佳,补充剂剂量的正确使用率>97%。未观察到、记录到或描述有副作用。
补充碧萝芷(®)12个月似乎可改善55至70岁正常受试者的认知功能和氧化应激水平。