修订"健康"参与者的定义,以证实食补充剂的结构/功能要求
Malkanthi Evans1, Erin D Lewis1, Joseph M Antony1
1Clinical Trials Division, KGK Science Inc, London, Ontario, Canada.
Journal of dietary supplements
|February 1, 2024
概括
"健康"的定义正在演变,影响了食补充剂的临床试验. 研究人员建议使用"生理稳定"或"明显健康"来更好地定义研究群体.
科学领域:
- 营养科学 营养科学
- 临床研究方法论 临床研究方法论
背景情况:
- "健康"的定义在临床实践和消费者认知中不断发展.
- 目前的标准如体重指数 (BMI) 和饮食参考摄入量 (DRI) 正在重新评估.
- 消费者关注的重点已经转移到包括活跃的生活方式和精神健康以及疾病管理.
研究的目的:
- 为了应对对食补充剂结构/功能 (S/F) 声明中定义"健康"人群的挑战.
- 在临床研究背景下提出"健康"的替代术语.
- 确保支持 S/F 索赔的证据的有效性.
主要方法:
- 审查目前对"健康"人口的定义和标准.
- 对美国食品和药物管理局 (FDA) 关于S/F声明的指导方针的分析.
- 讨论扩大疾病治疗指南对临床试验资格的影响.
主要成果:
- "健康"一词往往被解释为仅仅是疾病的缺失,这是变得不够的.
- 扩大疾病治疗指南,包括疾病风险生物标志物,减少了符合条件的"健康"志愿者.
- 现有的术语阻碍了对食补充剂的S / F主张的证据.
结论:
- 目前的"健康"定义对于支持食补充剂主张的临床试验是不够的.
- 其他术语如"生理稳定"或"看似健康"更适合.
- 采用新的术语将有助于食品和食补充剂行业和研究人员在证实S / F声称.
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