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
. 2022 Sep 23:9:958753.
doi: 10.3389/fnut.2022.958753. eCollection 2022.

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

Malkanthi Evans  1 , Erin D Lewis  1 , Joseph M Antony  1 , David C Crowley  1 , Najla Guthrie  1 , Jeffrey B Blumberg  2
Affiliations

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

Malkanthi Evans et al. Front Nutr. .

Abstract

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.

Keywords: clinical trials; dietary supplement; evidence-based nutrition; methodology; nutraceuticals.

PubMed Disclaimer

Conflict of interest statement

Authors ME, EL, DC, JA, and NG are/were employed by KGK Science Inc. The remaining author declares that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest.

Figures

Figure 1
Figure 1
The N-of-1 trial design used in comparing responses to two interventions. Adapted from Zucker et al. (45).
See this image and copyright information in PMC

References

    1. Health Canada . Policy Paper - Nutraceuticals/Functional Foods and Health Claims On Foods. Therapeutic Products Programme and the Food Directorate from the Health Protection Branch (Archived 2002). ARCHIVED - Policy Paper - Nutraceuticals/Functional Foods and Health Claims On Foods - Canada.ca; (2022).
    1. Durazzo A, Lucarini M, Santini A. Nutraceuticals in human health. Foods. (2020) 9:370. 10.3390/foods9030370 - DOI - PMC - PubMed
    1. Greene JA. Prescribing by Numbers: Drugs and the Definition of Disease. JHU Press; (2007).
    1. ClinicalTrials .gov. Trends, Charts, and Maps. Baltimore, MD: John Hopkins University Press. (2022).
    1. Brasil P, Pereira JP Jr, Moreira ME, Ribeiro Nogueira RM, Damasceno L, Wakimoto M, et al. . Zika virus infection in pregnant women in Rio de Janeiro. N Engl J Med. (2016) 375:2321–34. 10.1056/NEJMoa1602412 - DOI - PMC - PubMed

LinkOut - more resources