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Perspective: Fundamental Limitations of the Randomized Controlled Trial Method in Nutritional Research: The Example of Probiotics
Independent researcher, Nutriz, Enschede, The Netherlands.
Winclove Probiotics, Amsterdam, The Netherlands.
Örebro University, School of Medical Sciences. Nutrition-Gut-Brain Interactions Research Centre.ORCID iD: 0000-0002-0362-0008
Host Microbe Interactomics Group, Wageningen University, Wageningen, The Netherlands.
2018 (English)In: Advances in Nutrition, ISSN 2161-8313, Vol. 9, no 5, p. 561-571Article in journal (Refereed) Published
Abstract [en]

Studies on the relation between health and nutrition are often inconclusive. There are concerns about the validity of many research findings, and methods that can deliver high-quality evidence-such as the randomized controlled trial (RCT) method-have been embraced by nutritional researchers. Unfortunately, many nutritional RCTs also yield ambiguous results. It has been argued that RCTs are ill-suited for certain settings, including nutritional research. In this perspective, we investigate whether there are fundamental limitations of the RCT method in nutritional research. To this end, and to limit the scope, we use probiotic studies as an example. We use an epistemological approach and evaluate the presuppositions that underlie the RCT method. Three general presuppositions are identified and discussed. We evaluate whether these presuppositions can be considered true in probiotic RCTs, which appears not always to be the case. This perspective concludes by exploring several alternative study methods that may be considered for future probiotic or nutritional intervention trials.

Place, publisher, year, edition, pages
Oxford University Press, 2018. Vol. 9, no 5, p. 561-571
Keywords [en]
RCT limitations, probiotics, nutrition, study design
National Category
Nutrition and Dietetics
Identifiers
URN: urn:nbn:se:oru:diva-69092DOI: 10.1093/advances/nmy046ISI: 000444726300003PubMedID: 30124741OAI: oai:DiVA.org:oru-69092DiVA, id: diva2:1252304
Note

Funding Agency:

Gut Flora Foundation 

Available from: 2018-10-01 Created: 2018-10-01 Last updated: 2018-10-01Bibliographically approved

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Brummer, Robert Jan

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CiteExportLink to record
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Citation style
  • apa
  • harvard1
  • ieee
  • modern-language-association-8th-edition
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  • Other locale
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