Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
. 2024 Aug 30:13:102942.
doi: 10.1016/j.mex.2024.102942. eCollection 2024 Dec.

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

Júlia Oliveira Penteado  1 , Laiz Coutelle Honscha  1 , Caroline Lopes Feijo Fernandes  1 , Paula Florencio Ramires  1 , Ronan Adler Tavella  1 , Fernanda Oliveira Reis  1 , Mariane Pergher Soares  1 , Lisiane Martins Volcão  2 , Marina Dos Santos  3 , Ana Luiza Muccillo-Baisch  1 , Flavio Manoel Rodrigues da Silva-Júnior  1
Affiliations

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

Júlia Oliveira Penteado et al. MethodsX. .

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.•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.

Keywords: Nutrition; PEST-EXPO Brazil study; Pesticide; Toxicology; Trial methodology.

PubMed Disclaimer

Conflict of interest statement

The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper.

Figures

Image, graphical abstract
Graphical abstract
Fig. 1
Fig. 1
Eligibility Flowchart of RCT Participants.
Fig. 2
Fig. 2
Meal delivery flowchart for participants.
See this image and copyright information in PMC

Similar articles

See all similar articles

References

    1. Willett W., Rockström J., Loken B., Springmann M., Lang T., Vermeulen S., Murray C.J.L. Food in the Anthropocene: the EAT–Lancet Commission on healthy diets from sustainable food systems. The Lancet. 2019;393:447–492. doi: 10.1016/s0140-6736(18)3. - DOI - PubMed
    1. Caldas E.D., Jardim A.N.O. Exposure to toxic chemicals in the diet: Is the Brazilian population at risk? J. Expo Sci. Environ. Epidemiol. 2011;22(1):1–15. doi: 10.1038/jes.2011.35. - DOI - PubMed
    1. Wyckhuys K.A.G., Aebi A., Bijleveld van Lexmond M.F.I.J., Bojaca C.R., Bonmatin J.M., Furlan L., Ikenaka Y. Resolving the twin human and environmental health hazards of a plant-based diet. Environ. Int. 2020;144 doi: 10.1016/j.envint.2020.106081. - DOI - PubMed
    1. Fortes C., Mastroeni S., Pilla M.A., Antonelli G., Lunghini L., Aprea C. The relation between dietary habits and urinary levels of 3-phenoxybenzoic acid, a pyrethroid metabolite. Food Chem. Toxicol. 2013;2:91–96. - PubMed
    1. Xue J., Zartarian V., Tornero-Velez R., Tulve N.S. EPA's SHEDS-multimedia model: children's cumulative pyrethroid exposure estimates and evaluation against NHANES biomarker data. Environ. Int. 2014;73:304–311. - PubMed

LinkOut - more resources