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首页> 外文期刊>BMC Complementary and Alternative Medicine >A 12-week evaluation of annatto tocotrienol supplementation for postmenopausal women: safety, quality of life, body composition, physical activity, and nutrient intake
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A 12-week evaluation of annatto tocotrienol supplementation for postmenopausal women: safety, quality of life, body composition, physical activity, and nutrient intake

机译：为绝经后妇女补充安纳托生育三烯酚的12周评估：安全性，生活质量，身体成分，体育活动和营养摄入

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Evidence suggests that tocotrienols may benefit bone health in osteopenic women. However, their safety in this population has never been investigated. This study was to evaluate the safety of a 12-week supplementation of annato tocotrienol in postmenopausal osteopenic women, along with effects of the supplementation on quality of life, body composition, physical activity, and nutrient intake in this population. Eighty nine postmenopausal osteopenic women were randomly assigned to 3 treatment arms: (1) Placebo (430?mg olive oil/day), (2) Low tocotrientol (Low TT) (430?mg tocotrienol/day from DeltaGold 70 containing 300?mg tocotrienol) and (3) High tocotrienol (High TT) (860?mg tocotrienol/day from DeltaGold 70 containing 600?mg tocotrienol) for 12?weeks. DeltaGold 70 is an extract from annatto seed with 70% tocotrienol consisting of 90% delta-tocotrienol and 10% gamma-tocotrienol. Safety was examined by assessing liver enzymes (aspartate aminotransferase, alanine aminotransferase), alkaline phosphatase, bilirubin, kidney function (blood urea nitrogen and creatinine), electrolytes, glucose, protein, albumin, and globulin at 0, 6, and 12?weeks. Serum tocotrienol and tocopherol concentrations were assessed and pills counted at 0, 6, and 12?weeks. Quality of life, body composition, physical activity, and dietary macro- and micro-nutrient intake were evaluated at 0 and 12?weeks. A mixed model of repeated measures ANOVA was applied for analysis. Eighty seven subjects completed the study. Tocotrienol supplementation did not affect liver or kidney function parameters throughout the study. No adverse event due to treatments was reported by the participants. Tocotrienol supplementation for 6?weeks significantly increased serum delta-tocotrienol level and this high concentration was sustained to the end of study. There was no difference in serum delta-tocotrienol levels between the Low TT and the High TT groups. No effects of tocotrienol supplementation were observed on quality of life, body composition, physical activity, and nutrient intake. Annatto-derived tocotrienol up to 600?mg per day for 12?weeks appeared to be safe in postmenopausal osteopenic women, particularly in terms of liver and kidney functions. Tocotrienol supplementation for 12?weeks did not affect body composition, physical activity, quality of life, or intake of macro- and micro-nutrients in these subjects. ClinicalTrials.gov identifier: NCT02058420 . Title: Tocotrienols and bone health of postmenopausal women.
机译：有证据表明生育三烯酚可能有益于骨质疏松妇女的骨骼健康。但是，从未对其在这些人群中的安全性进行过调查。这项研究的目的是评估绝经后骨质减少的妇女中补充安那托生育三烯酚12周的安全性，以及补充对该人群生活质量，身体成分，身体活动和营养摄入的影响。八十九名绝经后骨质疏松症妇女被随机分配到3个治疗组中：（1）安慰剂（每天430？mg橄榄油），（2）低生育三烯酚（低TT）（每天430？mg生育三烯酚）来自DeltaGold 70含有300？mg （3）高生育三烯酚（高TT）（每天860mg mg生育三烯酚，每天从DeltaGold 70中获得600mg mg生育三烯酚）持续12周。 DeltaGold 70是从安纳托种子中提取的提取物，其中70％的生育三烯酚由90％的δ-生育三烯酚和10％的γ-生育三烯酚组成。通过在0、6和12周时评估肝酶（天冬氨酸氨基转移酶，丙氨酸氨基转移酶），碱性磷酸酶，胆红素，肾功能（血尿素氮和肌酐），电解质，葡萄糖，蛋白质，白蛋白和球蛋白来检查安全性。评估血清生育三烯酚和生育酚的浓度，并在0、6和12周时对药丸计数。在0周和12周时评估生活质量，身体成分，体育活动以及饮食中的大量和微量营养素摄入。重复测量方差分析的混合模型用于分析。八十七名受试者完成了研究。在整个研究过程中，补充三烯酚不会影响肝或肾功能参数。参加者未报告因治疗引起的不良事件。补充生育三烯酚6周后，血清δ-生育三烯酚水平显着增加，并且这种高浓度一直持续到研究结束。低TT组和高TT组之间的血清δ-生育三烯酚水平无差异。没有观察到补充生育三烯酚对生活质量，身体组成，体育活动和营养摄入的影响。在绝经后骨质减少的女性中，每天最多服用600毫克安那托的生育三烯酚对绝经后骨质减少的女性似乎是安全的，尤其是在肝和肾功能方面。补充生育三烯酚12周不会影响这些受试者的身体组成，体育活动，生活质量或摄入大量和微量营养素。 ClinicalTrials.gov标识符：NCT02058420。标题：生育三烯酚和绝经后妇女的骨骼健康。

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