Clinical Investigation of the Protective Effects of Palm Vitamin E Tocotrienols on Brain White Matter
Clinical Investigation of the Protective Effects of Palm Vitamin E Tocotrienols on Brain White Matter
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DOI：
10.1161/strokeaha.113.004449
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发表时间：
2014-05-01
期刊：
影响因子：
8.3
通讯作者：
Yuen, Kah Hay
中科院分区：
文献类型：
--
作者：
Gopalan, Yogheswaran;Shuaib, Ibrahim Lutfi;Yuen, Kah Hay
背景和目的以前的细胞和动物研究表明，混合生育三烯酚具有神经保护作用，但其作用尚未在人类中得到证实。因此，本研究旨在评价混合生育三烯酚对患有白色物质病变（WML）的人的保护活性。WMLs被认为是脑小血管疾病的表现，反映了不同程度的神经退行性变和组织损伤的潜在替代endpointinclinicaltrials.Methods共121名志愿者年龄35岁，心血管疾病的危险因素和MRI证实的WMLs随机接受200毫克混合生育三烯酚或安慰剂，每天两次，为期2年。使用经验证的软件，根据基线、1年和2年时拍摄的MRI图像测量WML体积，并进行比较。空腹血液样本收集全血chemicalinvestigation.Results根据每协议（88名志愿者）和意向治疗（121名志愿者）分析，平均WML体积的安慰剂组增加2年后，而生育三烯酚补充组基本保持不变。在1年结束时，两组之间的平均WML体积变化无显著差异（P=0.150），但在2年结束时，符合方案分析和意向治疗分析均具有显著性（P=0.019和P=0.018）。两组间的血液化学参数无显著性差异。结论发现混合生育三烯酚可减弱WMLs.Clinical Trial注册URL的进展：http://www.clinicaltrials.gov。唯一标识符：NCT 00753532。
Background and Purpose Previous cell-based and animal studies showed mixed tocotrienols are neuroprotective, but the effect is yet to be proven in humans. Thus, the present study aimed to evaluate the protective activity of mixed tocotrienols in humans with white matter lesions (WMLs). WMLs are regarded as manifestations of cerebral small vessel disease, reflecting varying degrees of neurodegeneration and tissue damage with potential as a surrogate end point in clinical trials.Methods A total of 121 volunteers aged 35 years with cardiovascular risk factors and MRI-confirmed WMLs were randomized to receive 200 mg mixed tocotrienols or placebo twice a day for 2 years. The WML volumes were measured from MRI images taken at baseline, 1 year, and 2 years using a validated software and were compared. Fasting blood samples were collected for full blood chemistry investigation.Results According to per-protocol (88 volunteers) and intention-to-treat (121 volunteers) analyses, the mean WML volume of the placebo group increased after 2 years, whereas that of the tocotrienol-supplemented group remained essentially unchanged. The mean WML volume change between the 2 groups was not significantly different (P=0.150) at the end of 1 year but was significant at the end of 2 years for both per-protocol and intention-to-treat analyses (P=0.019 and P=0.018). No significant difference was observed in the blood chemistry parameters between the 2 groups.Conclusions Mixed tocotrienols were found to attenuate the progression of WMLs.Clinical Trial Registration URL: http://www.clinicaltrials.gov. Unique identifier: NCT00753532.