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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,...
Autores principales: | , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
MDPI
2022
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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. |
format | Online Article Text |
id | pubmed-9227614 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2022 |
publisher | MDPI |
record_format | MEDLINE/PubMed |
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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