防止缺乏运动的营养鸡尾酒
鸡尾酒 XXS-2A/Omega-3 在 20 天身体不活动期间对胰岛素敏感性和氧化应激的影响:一项针对 20 名健康男性的随机对照试验研究
该实验包括将自由生活的活跃个体每天步数减少 20 天以诱发身体活动不足。 这将用于测试我们打算在 2016 年 ESA/CNES 计划的 60 天卧床休息期间作为新对策测试的抗氧化鸡尾酒的功效。
本研究的目的是研究包含维生素 E 和 omega-3 的天然抗氧化剂 XXS-2A 混合物是否有助于预防和/或减少葡萄糖耐受不良并改善由 20 天缺乏身体活动引起的每日步骤引起的氧化防御减少
尽管据报道身体不活动会在不活动的几天内影响葡萄糖耐量,但我们选择了 20 天的时间来发生鸡尾酒效应并评估次级分子机制。 在过去的 10 天里,这种短暂的不活动对新陈代谢的影响将通过服用果糖得到加强,果糖是一种在水果、蜂蜜和果汁中含量丰富的糖,众所周知,它会迅速引发代谢失调。
研究概览
研究类型
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
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Toulouse、法国、31405
- Medes-Imps
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
纳入标准:
- 健康的男性受试者,
- 20-45岁,
- 无肥胖或过瘦且BMI(体重Kg/身高m2)在22至27之间,
- 身高(厘米)在 158 至 190 厘米之间,
- 通过全面的临床评估(详细的病史和完整的体格检查)证明健康:特别是没有任何慢性疾病或任何急性传染病或耳鼻喉科、神经科、骨科、肌肉骨骼和心血管疾病,
- 在人群活跃范围内(10000-15000步/天)
- 利多卡因无禁忌症,
- 对花生或大豆不过敏,
- 不吸烟者或吸烟少于 5 支/天,
- 没有酒精,没有药物依赖,没有医疗,
规定
- 在与研究相关的任何程序之前给予书面知情同意,
- 由健康保险系统覆盖,
- 不受任何行政或法律监督,
- 不受监护或托管。
排除标准:
- 任何临床相关的心血管、神经或耳鼻喉科病史或存在,任何慢性疾病;任何急性传染病,
- 肥胖或过瘦,
- 不在人群活跃范围内(<10000步/天),
- 持续的医疗,
- 对采血耐受性差,
- 在实验开始前 8 周或更短时间内曾输过血(超过 8ml/kg),
- 有利多卡因禁忌症的受试者,
- 特别食物饮食、素食主义者或素食主义者或者食物补充,
- 食物过敏史,尤其是对花生或大豆过敏,
- 有明显的过敏史,
- 对以下任何测试的阳性反应:HVA IgM(甲型肝炎)、HBs 抗原(乙型肝炎)、抗 HVC 抗体(丙型肝炎)、抗 HIV1+2 抗体、
- 药物或酒精滥用史或存在(饮酒量 > 40 克/天)。
大体情况
- 根据研究者的判断,受试者可能在研究期间不依从,或由于语言问题或智力发育不良而无法合作,
- 根据适用法规,受试者处于先前研究的排除期,
- 作为研究对象在 12 个月内收到超过 4500 欧元的对象,
- 紧急情况下联系不上的对象,
- 被监禁的人,
- 受监护或托管的对象。
学习计划
研究是如何设计的?
设计细节
- 主要用途:基础科学
- 分配:随机化
- 介入模型:并行分配
- 屏蔽:无(打开标签)
武器和干预
参与者组/臂 |
干预/治疗 |
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实验性的:控制
干预:每日步数减少至每天 2000-3000 步且无结构化身体活动 + 在方案的最后 10 天内摄入高剂量果糖(3 克/千克/天)葡萄糖(0.5 克/千克/天)协议期间没有鸡尾酒 健康男性志愿者在活动范围(每天10000至15000步)年龄20-45岁,BMI 22 27 158 cm 身高190 cm,经综合临床评估证明为健康。 |
应遵循的习惯性饮食
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实验性的:鸡尾酒干预
干预:每日步数减少至每天 2000-3000 步且无结构化体育锻炼 + 在方案的最后 10 天内摄入高剂量果糖(3 克/千克/天)葡萄糖(0.5 克/千克/天) + 微量营养素鸡尾酒补充剂,含 560.7 毫克/天的多酚(3 粒/天)、2.1 克/天的 omega-3 脂肪酸(3 粒/天)、168 毫克/天的维生素 E 和 80µg/天硒日(1 粒/天) 健康男性志愿者在活动范围(每天10000至15000步)年龄20-45岁,BMI 22 27 158 cm 身高190 cm,经综合临床评估证明为健康。 |
微量营养素鸡尾酒补充剂,含 560.7 毫克/天的多酚(3 粒/天)、2.1 克/天的 omega-3 脂肪酸(3 粒/天)、168 毫克/天的维生素 E 和 80µg/天硒(1 粒/天)
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研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
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脂质氧化的变化
大体时间:20天
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在 4 小时 OGTT 期间通过间接量热法测量的脂质氧化变化
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20天
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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葡萄糖浓度的变化
大体时间:20天
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4 小时 OGTT 期间血浆葡萄糖浓度的变化
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20天
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胰岛素浓度的变化
大体时间:20天
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4 小时 OGTT 期间血浆胰岛素浓度的变化
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20天
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NEFA 的变化
大体时间:20天
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空腹血浆 NEFA 的变化
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20天
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甘油三酯的变化
大体时间:20天
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空腹血浆甘油三酯的变化
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20天
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从头脂肪生成
大体时间:20天
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在 VLDL-TG 中加入标记的果糖
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20天
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果糖氧化的变化
大体时间:20天
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摄入 1-13C 果糖后呼气样本中 13C 回收率的变化
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20天
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氧化应激的变化
大体时间:20天
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空腹还原型和氧化型谷胱甘肽的变化
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20天
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无脂肪质量的变化
大体时间:20天
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通过 DXA 测量的无脂肪质量变化
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20天
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参与交织蛋白质合成/胰岛素敏感性的肌肉通路
大体时间:每天测试4小时。所有协议 12 小时
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用肌肉活检获得的 Vastes lateralis 样本进行蛋白质印迹
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每天测试4小时。所有协议 12 小时
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合作者和调查者
出版物和有用的链接
一般刊物
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