Instituto de Nutrigenética y Nutrigenómica Traslacional, Centro Universitario de Ciencias de la Salud, Universidad de Guadalajara, Guadalajara 44340, Mexico.
Departamento de Biología Molecular y Genómica, Centro Universitario de Ciencias de la Salud, Universidad de Guadalajara, Guadalajara 44340, Mexico.
Nutrients. 2022 Jun 7;14(12):2365. doi: 10.3390/nu14122365.
Nutrition is an essential component when promoting human health. Without a doubt, improving the quality of one's diet can improve one's quality of life as a whole and help postpone the onset or control of many chronic diseases. The volume of publications in this field has increased in recent years, in line with increased awareness of the importance of nutrition in health; however, the quality of the evidence on which most nutritional guidelines are based remains low, due to errors in conducting nutritional interventions or because the information is primarily derived from observational studies. To enhance the evidence supporting clinical guidelines in nutrition, the quality of randomized clinical trials (RCT) based on nutritional interventions must be improved; nevertheless, due to their heterogeneous nature and a lack of specific guidelines for designing, performing, documenting, and reporting on this type of intervention, conducting a nutritional intervention is a real challenge. Following a review of the literature on the methodological and ethical standards, as well as four extensions of the CONSORT (Consolidated Standards of Reporting Trials) guidelines that should be considered when implementing a nutritional intervention, seven essential aspects were identified. The current narrative review includes definitions, examples, diagrams, and algorithms regarding aspects of the appropriate study design, the intervention of the control group, the randomization and blinding processes, the study population selection, as well as a description of the type of intervention and the personnel involved in carrying out the study in order to make the implementation of a nutritional intervention easier.
营养是促进人类健康的重要组成部分。毫无疑问，改善饮食质量可以整体提高生活质量，并有助于延缓许多慢性疾病的发生或控制。近年来，随着人们对营养在健康中的重要性认识的提高，该领域的出版物数量有所增加；然而，大多数营养指南所依据的证据质量仍然较低，这是由于营养干预措施中的错误，或者是因为信息主要来自观察性研究。为了增强营养临床指南的证据，必须提高基于营养干预的随机临床试验（RCT）的质量；然而，由于其具有异质性，并且缺乏针对这种干预设计、执行、记录和报告的具体指南，进行营养干预确实是一个挑战。在对文献进行方法学和伦理标准审查以及对 CONSORT（临床试验报告的统一标准）指南的四项扩展进行审查后，确定了七个必要方面。本综述包括关于适当研究设计、对照组干预、随机化和盲法过程、研究人群选择的定义、示例、图表和算法，以及对干预类型和参与实施研究的人员的描述，以方便实施营养干预。
