Penteado Júlia Oliveira, Honscha Laiz Coutelle, Fernandes Caroline Lopes Feijo, Ramires Paula Florencio, Tavella Ronan Adler, Reis Fernanda Oliveira, Soares Mariane Pergher, Volcão Lisiane Martins, Dos Santos Marina, Muccillo-Baisch Ana Luiza, da Silva-Júnior Flavio Manoel Rodrigues
Federal University of Rio Grande, Itália Avenue, Km 8, Carreiros, 96203-900 Rio Grande, Rio Grande do Sul, Brazil.
Southern Frontier University, Jacob Reinaldo Haupenthal Avenue, 1580, 9790-000 Cerro Largo, RS, Brazil.
MethodsX. 2024 Aug 30;13:102942. doi: 10.1016/j.mex.2024.102942. eCollection 2024 Dec.
Randomized clinical trials are considered the gold standard for studies with dietary interventions, which is mainly due to the fact that they can establish causal relationships between food exposure and body composition measures or biomarkers. The aim of this study was to describe the details of a double-blind, randomized, clinical trial protocol to identify, characterize and evaluate the effects of human dietary exposure to pesticide residues in food. Specific aspects of planning (development of a research question, determination of objectives, selection of participants, randomization and blinding) and performance (recruitment of participants, measures to improve adherence, data collection, follow-up and evaluation of results) are addressed in this study. The study design proved effective in characterizing dietary patterns with foods originating from both conventional and organic agriculture. A total of 148 individuals were recruited for the study. The conventional group was represented by 47 % of the sample and the organic group was represented by 53 %. The practice of evidence-based nutrition has demanded that trials be well designed and systematically performed in the field of clinical nutrition. Therefore, this clinical trial emphasizes the importance of improving studies with toxicological nutrition that assess sources of exposure through food.•This double-blind, randomized clinical trial details the protocol for identifying, characterizing, and evaluating the effects of dietary exposure to pesticide residues.•The protocol demonstrates that well-designed and systematically conducted trials emphasize the importance of robust methodologies in evidence-based nutrition.•In the face of the global climate crisis, this clinical trial underscores the importance of enhancing studies in toxicological nutrition, particularly those evaluating sources of exposure through food, to better understand the dietary impacts on health.
随机临床试验被认为是饮食干预研究的金标准，这主要是因为它们能够确立食物暴露与身体成分指标或生物标志物之间的因果关系。本研究的目的是描述一项双盲、随机临床试验方案的细节，以识别、表征和评估人类饮食中接触食物中农药残留的影响。本研究涉及规划（研究问题的提出、目标的确定、参与者的选择、随机化和盲法）和实施（参与者的招募、提高依从性的措施、数据收集、随访和结果评估）的具体方面。该研究设计在表征来自传统农业和有机农业的食物的饮食模式方面证明是有效的。共有148人被招募参加该研究。样本中47%为传统组，53%为有机组。循证营养的实践要求在临床营养领域进行精心设计和系统实施的试验。因此，这项临床试验强调了改进毒理学营养研究的重要性，这类研究通过食物评估暴露源。• 这项双盲、随机临床试验详细说明了识别、表征和评估饮食中接触农药残留影响的方案。• 该方案表明，精心设计和系统开展的试验强调了循证营养中稳健方法的重要性。• 面对全球气候危机，这项临床试验强调了加强毒理学营养研究的重要性，特别是那些评估通过食物的暴露源的研究，以便更好地了解饮食对健康的影响。
