Shen Chwan-Li, Mo Huanbiao, Yang Shengping, Wang Shu, Felton Carol K, Tomison Michael D, Soelaiman Ima Nirwana
Department of Pathology, Texas Tech University Health Sciences Center, Lubbock, Texas, USA.
Department of Nutrition, Byrdine F. Lewis School of Nursing and Health Professions, Georgia State University, Atlanta, Georgia, USA.
BMJ Open. 2016 Dec 23;6(12):e012572. doi: 10.1136/bmjopen-2016-012572.
Osteoporosis is a major health concern in postmenopausal women, and oxidative stress contributes to the development of bone loss. Cellular studies and ovariectomised rat model mimicking bone loss in postmenopausal women show the bone-protective effect of tocotrienols (TTs) with antioxidant capability. We aim to access the safety and efficacy of TT consumption for bone health in postmenopausal women.
In this 12-week randomised double-blinded placebo-controlled trial for the effects of dietary TT supplementation in postmenopausal women, postmenopausal women aged 45 years and older with at least 1 year after menopause and bone mineral density T-score at the spine and/or hip 2.5 or more below the reference values will be randomly assigned to 3 daily supplements: (1) placebo group receiving 860 mg olive oil, (2) low TT group receiving 430 mg of 70% pure TTs (containing 300 mg TT) and (3) high TT group receiving 860 mg of 70% pure TTs (600 mg TT). The primary outcome measure will be urinary N-terminal telopeptide. The secondary outcome measures will be serum bone-specific alkaline phosphatase, receptor activator of nuclear factor-κB ligand, osteoprotegerin, urinary 8-hydroxy-2'-deoxyguanosine and quality of life. At 0, 6 and 12 weeks, the following will be assessed: (1) primary and secondary outcome measures; (2) serum TT and tocopherol concentrations; (3) physical activity and food frequency questionnaires. Liver function will be monitored every 6 weeks for safety. 'Intent-to-treat' principle will be employed for data analysis. A model of repeated measurements with random effect error terms will be applied. Analysis of covariance, χ analysis and regression will be used for comparisons.
This study was approved by the Bioethics Committee of the Texas Tech University Health Sciences Center. The findings of this trial will be submitted to a peer-reviewed journal in the areas of bone or nutrition and international conferences.
NCT02058420; results.
骨质疏松症是绝经后女性的一个主要健康问题，氧化应激会导致骨质流失。细胞研究以及模拟绝经后女性骨质流失的去卵巢大鼠模型显示，具有抗氧化能力的生育三烯酚（TTs）具有保护骨骼的作用。我们旨在评估绝经后女性食用TTs对骨骼健康的安全性和有效性。
在这项为期12周的随机双盲安慰剂对照试验中，研究膳食补充TTs对绝经后女性的影响，年龄在45岁及以上、绝经至少1年且脊柱和/或髋部骨密度T值比参考值低2.5或更多的绝经后女性将被随机分配到3种每日补充剂组：（1）安慰剂组，服用860毫克橄榄油；（2）低剂量TT组，服用430毫克70%纯度的TTs（含300毫克TT）；（3）高剂量TT组，服用860毫克70%纯度的TTs（600毫克TT）。主要结局指标将是尿N端肽。次要结局指标将是血清骨特异性碱性磷酸酶、核因子κB受体激活剂配体、骨保护素、尿8-羟基-2'-脱氧鸟苷和生活质量。在第0、6和12周时，将评估以下内容：（1）主要和次要结局指标；（2）血清TT和生育酚浓度；（3）身体活动和食物频率问卷。每6周监测一次肝功能以确保安全。数据分析将采用“意向性分析”原则。将应用带有随机效应误差项的重复测量模型。协方差分析、χ分析和回归分析将用于比较。
本研究已获得德克萨斯理工大学健康科学中心生物伦理委员会的批准。本试验的结果将提交给骨科学或营养领域的同行评审期刊以及国际会议。
NCT02058420；结果
