A study protocol for a randomized clinical trial on exposure and effects of pesticides consumption - the PEST-EXPO Brazil study

IF 1.6 Q2 MULTIDISCIPLINARY SCIENCES

MethodsX Pub Date : 2024-08-30 DOI:10.1016/j.mex.2024.102942

Júlia Oliveira Penteado , Laiz Coutelle Honscha , Caroline Lopes Feijo Fernandes , Paula Florencio Ramires , Ronan Adler Tavella , Fernanda Oliveira Reis , Mariane Pergher Soares , Lisiane Martins Volcão , Marina dos Santos , Ana Luiza Muccillo-Baisch , Flavio Manoel Rodrigues da Silva-Júnior

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Abstract

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.

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This double-blind, randomized clinical trial details the protocol for identifying, characterizing, and evaluating the effects of dietary exposure to pesticide residues.
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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.

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关于农药消费的暴露和影响的随机临床试验的研究方案--巴西 PEST-EXPO 研究

随机临床试验被认为是膳食干预研究的黄金标准，这主要是因为它们可以确定食物摄入量与身体成分测量或生物标志物之间的因果关系。本研究旨在描述双盲、随机临床试验方案的细节，以确定、描述和评估人类膳食暴露于食品中农药残留的影响。本研究探讨了计划（研究问题的提出、目标的确定、参与者的选择、随机化和盲法）和执行（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。事实证明，这种研究设计能有效地描述传统农业和有机农业食品的膳食模式。研究共招募了 148 人。常规组占样本的 47%，有机组占样本的 53%。循证营养学的实践要求临床营养学领域的试验必须精心设计和系统进行。因此，这项临床试验强调了改进毒理学营养研究的重要性，以评估通过食物接触农药的来源。-面对全球气候危机，这项临床试验强调了加强毒理学营养学研究的重要性，特别是那些评估通过食物暴露源的研究，以便更好地了解膳食对健康的影响。

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