背景饮食和坚持营养试验的忽视的影响
Javier I Ottaviani1, Hagen Schroeter1, Dennis M Bier2
1Mars, Inc., McLean, VA.
medRxiv : the preprint server for health sciences
|March 10, 2025
概括
随机对照试验 (RCT) 中的营养生物标志物分析显示,背景饮食和坚持显著影响干预结果. 基于生物标志物的分析为营养干预提供了比传统方法更可靠的效果估计.
科学领域:
- 营养科学 营养科学
- 心血管疾病研究研究
- 临床试验方法论 临床试验方法论
背景情况:
- 营养随机对照试验 (RCTN) 面临的挑战是量化背景饮食和坚持,可能掩盖真正的干预效应.
- 这些混因素对RCTN结果的确切影响尚不清楚.
研究的目的:
- 量化背景饮食和坚持的影响,通过验证的黄素摄入量的营养生物标志物评估,对大型RCTN的结果.
- 在营养干预研究中,比较基于生物标志物分析的疗效与传统的治疗意图和每协议分析.
主要方法:
- 可可补充剂和多维生素结局研究 (COSMOS) 的一个副研究,涉及6532名参与者,分别是安慰剂和可可提取物.
- 利用尿液中的黄醇生物标志物来评估背景饮食摄入量和坚持可可提取物补充剂.
- 对心血管疾病 (CVD) 事件,心血管疾病死亡率和全因死亡率的危险比率 (HRs) 估计使用基于治疗意图,每个协议和基于生物标志物的分析.
主要成果:
- 生物标志物分析显示,20%的参与者有显著的背景黄摄入量,33%的参与者表现不佳,超过了自我报告的估计值.
- 基于生物标志物的分析与治疗意图和每条协议分析相比,产生了更强的效果估计.
- 对于总体心血管疾病事件,HR从0.79 (每项协议) 降低到0.65 (基于生物标志物),对心血管疾病死亡率,所有原因死亡率和主要心血管疾病事件观察到类似的减少.
结论:
- 纳入营养生物标志物数据对于准确评估RCTN中的干预效应至关重要.
- 基于生物标志物的分析提高了营养干预试验结果的一致性和可靠性.
- 这种方法提供了一种更强大的方法来评估饮食干预措施的有效性.
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