关键词: clinical investigators evidence-based human nutrition randomized controlled trials

Mesh : Diet Humans Malnutrition Nutritional Status Quality of Life Randomized Controlled Trials as Topic

来  源:   DOI:10.1093/advances/nmaa083   PDF(Sci-hub)   PDF(Pubmed)

Abstract:
Guidelines for designing, conducting, documenting, and reporting human nutrition randomized controlled trials (RCTs) have as yet to be developed and disseminated as reference for investigators, funders, regulators, institutions, assessors, trainees, and others involved in human nutrition research. Diet-related interventions can include diet and/or behavioral manipulation, provision of foods or entire meals, or delivery of dietary components in individual food items or supplements. This Perspective introduces a series of papers that outline core principles for the design and conduct of human nutrition RCTs, documentation and reporting of all aspects of clinical trial management, and data analysis and reporting of results. Human nutrition RCTs have unique considerations delineated in these papers. Conducting them with the highest scientific rigor is essential to the development of evidence-based dietary guidance for promoting optimal health and advancing health care.
摘要:
设计指南,导电,记录,并报告人类营养随机对照试验(RCTs)尚未开发和传播,作为研究人员的参考,资助者,监管者,机构,评估人员,学员,和其他参与人类营养研究的人。与饮食相关的干预措施可以包括饮食和/或行为操纵,提供食物或整餐,或在单个食品或补充剂中输送膳食成分。本观点介绍了一系列论文,概述了人类营养随机对照试验的设计和实施的核心原则,临床试验管理各个方面的文档和报告,以及数据分析和结果报告。人类营养RCT具有这些论文中描述的独特考虑因素。以最高的科学严谨性开展这些活动对于制定基于证据的饮食指导,以促进最佳健康和推进医疗保健至关重要。
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