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Breaking new frontiers: Assessment and re-evaluation of clinical trial design for nutraceuticals

Despite sophisticated study designs and measurement tools, we have yet to create an innovative space for diet and dietary supplements in the health care system. The path is challenging due to current hierarchies of scientific evidence and regulatory affairs. The role of the randomized, double-blind,...

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Autores principales: Evans, Malkanthi, Lewis, Erin D., Antony, Joseph M., Crowley, David C., Guthrie, Najla, Blumberg, Jeffrey B.
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Frontiers Media S.A. 2022
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9540398/
https://www.ncbi.nlm.nih.gov/pubmed/36211523
http://dx.doi.org/10.3389/fnut.2022.958753
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author Evans, Malkanthi
Lewis, Erin D.
Antony, Joseph M.
Crowley, David C.
Guthrie, Najla
Blumberg, Jeffrey B.
author_facet Evans, Malkanthi
Lewis, Erin D.
Antony, Joseph M.
Crowley, David C.
Guthrie, Najla
Blumberg, Jeffrey B.
author_sort Evans, Malkanthi
collection PubMed
description Despite sophisticated study designs and measurement tools, we have yet to create an innovative space for diet and dietary supplements in the health care system. The path is challenging due to current hierarchies of scientific evidence and regulatory affairs. The role of the randomized, double-blind, placebo-controlled clinical trial (RCT) as a research approach functions well to characterize the benefits and risks of drugs but lacks the sensitivity to capture the efficacy and safety of nutraceuticals. While some facets of RCTs can be relevant and useful when applied to nutraceuticals, other aspects are limiting and potentially misleading when taken in their entirety. A differentiation between guidelines for evidence-based medicine and the evidence required for nutrition spotlight the need to reconceptualize constituents of the RCT and their applicability with relevance to health promotion. This perspective identifies the limitations of the traditional RCT to capture the complexities of nutraceuticals and proposes the N-of-1 as Level 1 evidence better suited for the proof of efficacy of nutraceuticals.
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spelling pubmed-95403982022-10-08 Breaking new frontiers: Assessment and re-evaluation of clinical trial design for nutraceuticals Evans, Malkanthi Lewis, Erin D. Antony, Joseph M. Crowley, David C. Guthrie, Najla Blumberg, Jeffrey B. Front Nutr Nutrition Despite sophisticated study designs and measurement tools, we have yet to create an innovative space for diet and dietary supplements in the health care system. The path is challenging due to current hierarchies of scientific evidence and regulatory affairs. The role of the randomized, double-blind, placebo-controlled clinical trial (RCT) as a research approach functions well to characterize the benefits and risks of drugs but lacks the sensitivity to capture the efficacy and safety of nutraceuticals. While some facets of RCTs can be relevant and useful when applied to nutraceuticals, other aspects are limiting and potentially misleading when taken in their entirety. A differentiation between guidelines for evidence-based medicine and the evidence required for nutrition spotlight the need to reconceptualize constituents of the RCT and their applicability with relevance to health promotion. This perspective identifies the limitations of the traditional RCT to capture the complexities of nutraceuticals and proposes the N-of-1 as Level 1 evidence better suited for the proof of efficacy of nutraceuticals. Frontiers Media S.A. 2022-09-23 /pmc/articles/PMC9540398/ /pubmed/36211523 http://dx.doi.org/10.3389/fnut.2022.958753 Text en Copyright © 2022 Evans, Lewis, Antony, Crowley, Guthrie and Blumberg. 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
Evans, Malkanthi
Lewis, Erin D.
Antony, Joseph M.
Crowley, David C.
Guthrie, Najla
Blumberg, Jeffrey B.
Breaking new frontiers: Assessment and re-evaluation of clinical trial design for nutraceuticals
title Breaking new frontiers: Assessment and re-evaluation of clinical trial design for nutraceuticals
title_full Breaking new frontiers: Assessment and re-evaluation of clinical trial design for nutraceuticals
title_fullStr Breaking new frontiers: Assessment and re-evaluation of clinical trial design for nutraceuticals
title_full_unstemmed Breaking new frontiers: Assessment and re-evaluation of clinical trial design for nutraceuticals
title_short Breaking new frontiers: Assessment and re-evaluation of clinical trial design for nutraceuticals
title_sort breaking new frontiers: assessment and re-evaluation of clinical trial design for nutraceuticals
topic Nutrition
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9540398/
https://www.ncbi.nlm.nih.gov/pubmed/36211523
http://dx.doi.org/10.3389/fnut.2022.958753
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