Abstract：
Double-blind, placebo-controlled, randomized controlled trials are the gold standard for clinical trials in nutrition science. For trials of whole diets, dietary counseling is advantageous as they offer clinical translatability although can vary in the fidelity of the intended intervention from participant to participant and across studies. Feeding trials, in which most or all food is provided, offer high precision and can provide proof-of-concept evidence that a dietary intervention is efficacious and can also better evaluate the effect of known quantities of foods and nutrients on physiology. However, they come with additional methodological complexities. Feeding trials also call for a variety of unique methodological considerations, not least of which relate to the design and delivery of diets to participants. This review aims to provide a comprehensive summary of recommendations for design and conduct of feeding trials, encompassing domiciled and nondomiciled feeding trials. Several pertinent aspects of trial design and methodology are discussed, including defining the study population to maximize retention, safety, and generalizability of findings, recommendations for design of control interventions and optimizing blinding, and specific considerations for clinical populations. A detailed stepwise process for menu design, development, validation, and delivery are also presented. These recommendations aim to facilitate methodologic consistency and execution of high-quality feeding trials, ultimately facilitating improved understanding of the role of diet in treating disease and the underpinning mechanisms.
摘要：
双盲,安慰剂对照,随机对照试验是营养科学临床试验的金标准。对于整个饮食的试验，饮食咨询是有利的,因为它们提供了临床可翻译性,尽管在不同参与者和不同研究中,预期干预的保真度可能不同.喂养试验，提供大部分或所有食物，提供高精度，并可以提供概念证明，证明饮食干预是有效的，还可以更好地评估已知量的食物和营养素对生理的影响。然而,它们带来了额外的方法复杂性。喂养试验还需要各种独特的方法学考虑,尤其是与设计和向参与者提供饮食有关。这篇综述旨在为喂养试验的设计和进行提供全面的建议摘要，包括有住所和无住所的喂养试验。讨论了试验设计和方法的几个相关方面，包括定义研究人群以最大限度地保留，发现的安全性和普遍性，设计控制干预措施和优化盲法的建议，以及临床人群的具体考虑。菜单设计的详细逐步过程，发展,还介绍了验证和交付。这些建议旨在促进高质量喂养试验的方法学一致性和执行。最终促进对饮食在治疗疾病中的作用和基础机制的理解。
