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首页> 外文期刊>Current therapeutic research, clinical and experimental. >Effects of D-003, a Mixture of High-Molecular-Weight Sugar Cane Wax Acids, on Lipid Peroxidation Markers in Older Individuals: A Randomized, Double-Blind, Placebo-Controlled Study
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Effects of D-003, a Mixture of High-Molecular-Weight Sugar Cane Wax Acids, on Lipid Peroxidation Markers in Older Individuals: A Randomized, Double-Blind, Placebo-Controlled Study

机译:D-003,一种高分子量甘蔗蜡酸的混合物,对老年人脂质过氧化标记的影响:一项随机,双盲,安慰剂对照的研究

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BACKGROUND: Aging is associated with increased lipid peroxidation (LP). D-003, a mixture of long-chain aliphatic primary acids purified from sugar cane wax, has been found to inhibit LP in experimental models and in healthy subjects.OBJECTIVES: The aim of this study was to assess the effects of D-003 on LP markers and the lipid profile of older individuals.METHODS: This randomized, double-blind, placebo-controlled study was conducted at the Plaza Veterans' House, Havana City, Cuba. Male and female patients aged >60 years with total cholesterol values of <6.1 mmol/L were eligible for inclusion in the study. After a 3-week lead-in and baseline assessment period, patients were randomized to receive PO D-003 5 mg/d, D-003 10 mg/d, or placebo for 8 weeks. The effect on copper-induced LP of low-density lipoprotein (LDL) particles was the primary variable, and the effects on plasma total antioxidant status (TAS), plasma malondialdehyde (MDA) concentration, plasma antioxidant enzyme (superoxide dismutase and gluta-thione peroxidase) activities, and the lipid profile were secondary variables. A clinical examination was performed at each visit (baseline, weeks 4 and 8). A clinical examination, LP, and blood tests (lipid profile, hematologic, and blood biochemistry safety indicators) were performed at baseline and after 8 weeks of treatment. Compliance and adverse events (AEs) were assessed at weeks 4 and 8. A 2-tailed P < 0.05 was considered statistically significant for comparisons of both continuous and categoric variables.
机译:背景:衰老与脂质过氧化(LP)增加有关。 D-003是从甘蔗蜡中纯化的长链脂肪族伯酸的混合物,在实验模型和健康受试者中均能抑制LP。目标:本研究的目的是评估D-003对糖尿病的影响LP标记和老年人的脂质分布。方法:这项随机,双盲,安慰剂对照的研究在古巴哈瓦那市的Plaza Veterans'House进行。年龄大于60岁且总胆固醇值小于6.1 mmol / L的男性和女性患者符合纳入研究的条件。经过3周的引导期和基线评估期后,患者被随机分配接受PO D-003 5 mg / d,D-003 10 mg / d或安慰剂治疗8周。低密度脂蛋白(LDL)颗粒对铜诱导的LP的影响是主要变量,对血浆总抗氧化剂状态(TAS),血浆丙二醛(MDA)浓度,血浆抗氧化剂酶(超氧化物歧化酶和戊二硫酮)的影响过氧化物酶活性和脂质分布是次要变量。每次访视时进行临床检查(基线,第4周和第8周)。在基线和治疗8周后进行了临床检查,LP和血液测试(血脂,血液学和血液生化安全指标)。在第4周和第8周评估依从性和不良事件(AE)。对于连续变量和分类变量的比较,2尾P <0.05被认为具有统计学意义。

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