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Methodological Aspects in Randomized Clinical Trials of Nutritional Interventions

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,...

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Autores principales: Martínez-López, Erika, Pérez-Guerrero, Edsaúl Emilio, Torres-Carrillo, Nora Magdalena, López-Quintero, Andres, Betancourt-Núñez, Alejandra, Gutiérrez-Hurtado, Itzae Adonai
Formato: Online Artículo Texto
Lenguaje:English
Publicado: MDPI 2022
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9227614/
https://www.ncbi.nlm.nih.gov/pubmed/35745096
http://dx.doi.org/10.3390/nu14122365
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author Martínez-López, Erika
Pérez-Guerrero, Edsaúl Emilio
Torres-Carrillo, Nora Magdalena
López-Quintero, Andres
Betancourt-Núñez, Alejandra
Gutiérrez-Hurtado, Itzae Adonai
author_facet Martínez-López, Erika
Pérez-Guerrero, Edsaúl Emilio
Torres-Carrillo, Nora Magdalena
López-Quintero, Andres
Betancourt-Núñez, Alejandra
Gutiérrez-Hurtado, Itzae Adonai
author_sort Martínez-López, Erika
collection PubMed
description 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.
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spelling pubmed-92276142022-06-25 Methodological Aspects in Randomized Clinical Trials of Nutritional Interventions Martínez-López, Erika Pérez-Guerrero, Edsaúl Emilio Torres-Carrillo, Nora Magdalena López-Quintero, Andres Betancourt-Núñez, Alejandra Gutiérrez-Hurtado, Itzae Adonai Nutrients Review 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. MDPI 2022-06-07 /pmc/articles/PMC9227614/ /pubmed/35745096 http://dx.doi.org/10.3390/nu14122365 Text en © 2022 by the authors. https://creativecommons.org/licenses/by/4.0/Licensee MDPI, Basel, Switzerland. This article is an open access article distributed under the terms and conditions of the Creative Commons Attribution (CC BY) license (https://creativecommons.org/licenses/by/4.0/).
spellingShingle Review
Martínez-López, Erika
Pérez-Guerrero, Edsaúl Emilio
Torres-Carrillo, Nora Magdalena
López-Quintero, Andres
Betancourt-Núñez, Alejandra
Gutiérrez-Hurtado, Itzae Adonai
Methodological Aspects in Randomized Clinical Trials of Nutritional Interventions
title Methodological Aspects in Randomized Clinical Trials of Nutritional Interventions
title_full Methodological Aspects in Randomized Clinical Trials of Nutritional Interventions
title_fullStr Methodological Aspects in Randomized Clinical Trials of Nutritional Interventions
title_full_unstemmed Methodological Aspects in Randomized Clinical Trials of Nutritional Interventions
title_short Methodological Aspects in Randomized Clinical Trials of Nutritional Interventions
title_sort methodological aspects in randomized clinical trials of nutritional interventions
topic Review
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9227614/
https://www.ncbi.nlm.nih.gov/pubmed/35745096
http://dx.doi.org/10.3390/nu14122365
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