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Designing, Conducting, and Documenting Human Nutrition Plant-Derived Intervention Trials
Best practices for designing, conducting, documenting, and reporting human nutrition randomized controlled trials were developed and published in Advances in Nutrition. Through an example of the randomized clinical trial on blueberries and bone health funded by the National Institutes of Health, thi...
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Formato: | Online Artículo Texto |
Lenguaje: | English |
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Frontiers Media S.A.
2021
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Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8733730/ https://www.ncbi.nlm.nih.gov/pubmed/35004813 http://dx.doi.org/10.3389/fnut.2021.782703 |
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author | Weaver, Connie M. Hodges, J. Kalina |
author_facet | Weaver, Connie M. Hodges, J. Kalina |
author_sort | Weaver, Connie M. |
collection | PubMed |
description | Best practices for designing, conducting, documenting, and reporting human nutrition randomized controlled trials were developed and published in Advances in Nutrition. Through an example of the randomized clinical trial on blueberries and bone health funded by the National Institutes of Health, this paper will illustrate the elements of those best practices that apply specifically to plant-based intervention clinical trials. Unique study design considerations for human feeding interventions with bioactive plant compounds include the difficulty of blinding the intervention, background nutritional status of participants, carry-over effects of the intervention, benefits of a run-in period, lack of safety/tolerability data, and nutrition-specific regulatory policies. Human nutrition randomized controlled trials are the gold standard for establishing causal relations between an intervention and health outcome measures. Rigorous studies and documentation define the quality of the evidence-base to inform public health guidelines and to establish personalized dietary recommendations for the health-promoting plant components. |
format | Online Article Text |
id | pubmed-8733730 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2021 |
publisher | Frontiers Media S.A. |
record_format | MEDLINE/PubMed |
spelling | pubmed-87337302022-01-07 Designing, Conducting, and Documenting Human Nutrition Plant-Derived Intervention Trials Weaver, Connie M. Hodges, J. Kalina Front Nutr Nutrition Best practices for designing, conducting, documenting, and reporting human nutrition randomized controlled trials were developed and published in Advances in Nutrition. Through an example of the randomized clinical trial on blueberries and bone health funded by the National Institutes of Health, this paper will illustrate the elements of those best practices that apply specifically to plant-based intervention clinical trials. Unique study design considerations for human feeding interventions with bioactive plant compounds include the difficulty of blinding the intervention, background nutritional status of participants, carry-over effects of the intervention, benefits of a run-in period, lack of safety/tolerability data, and nutrition-specific regulatory policies. Human nutrition randomized controlled trials are the gold standard for establishing causal relations between an intervention and health outcome measures. Rigorous studies and documentation define the quality of the evidence-base to inform public health guidelines and to establish personalized dietary recommendations for the health-promoting plant components. Frontiers Media S.A. 2021-12-23 /pmc/articles/PMC8733730/ /pubmed/35004813 http://dx.doi.org/10.3389/fnut.2021.782703 Text en Copyright © 2021 Weaver and Hodges. https://creativecommons.org/licenses/by/4.0/This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) and the copyright owner(s) are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms. |
spellingShingle | Nutrition Weaver, Connie M. Hodges, J. Kalina Designing, Conducting, and Documenting Human Nutrition Plant-Derived Intervention Trials |
title | Designing, Conducting, and Documenting Human Nutrition Plant-Derived Intervention Trials |
title_full | Designing, Conducting, and Documenting Human Nutrition Plant-Derived Intervention Trials |
title_fullStr | Designing, Conducting, and Documenting Human Nutrition Plant-Derived Intervention Trials |
title_full_unstemmed | Designing, Conducting, and Documenting Human Nutrition Plant-Derived Intervention Trials |
title_short | Designing, Conducting, and Documenting Human Nutrition Plant-Derived Intervention Trials |
title_sort | designing, conducting, and documenting human nutrition plant-derived intervention trials |
topic | Nutrition |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8733730/ https://www.ncbi.nlm.nih.gov/pubmed/35004813 http://dx.doi.org/10.3389/fnut.2021.782703 |
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