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On the importance of intraindividual variation in nutritional research
Vrije Universiteit Amsterdam, Athena Institute, Amsterdam, the Netherlands.
Vrije Universiteit Amsterdam, Athena Institute, Amsterdam, the Netherlands.
Örebro University, School of Medical Sciences. (Nutrition-Gut-Brain Interactions Research Centre)ORCID iD: 0000-0002-0362-0008
2020 (English)In: Beneficial Microbes, ISSN 1876-2883, E-ISSN 1876-2891, Vol. 11, no 6, p. 511-517Article in journal (Refereed) Published
Abstract [en]

Nutritional intervention studies, like those with pre- and probiotics, are often hampered by low effect sizes, reducing the power to demonstrate potential efficacy. Here, we perform computer simulations of a hypothetical clinical trial using such an intervention in order to elucidate determining factors that can be influenced in order to optimise the statistical power. Our simulations demonstrate that steering the study population towards a low intraindividual variation dramatically improves statistical power. A more than 10-fold decrease of number-to-treat could be reached. Also, a careful balancing between the number of subjects and measurements per subject, in combination with possible stratification of the subjects into responders and non-responders, based on inherent intraindividual variation, improves the likelihood to reach statistically significant results. Our results also show that traditional dogmas, with respect to clinical trials, i.e. aiming at low interindividual variation and a high number (n) of study participants, should be re-evaluated in favour of reducing intraindividual variation. This reduction in intraindividual variation could be achieved by maintaining a steady lifestyle, including dietary habits among others, within the timeframe of the intervention study.

Place, publisher, year, edition, pages
Wageningen Academic Publishers, 2020. Vol. 11, no 6, p. 511-517
Keywords [en]
Clinical trial, nutrition, prebiotics, probiotics, statistics
National Category
Nutrition and Dietetics
Identifiers
URN: urn:nbn:se:oru:diva-86397DOI: 10.3920/BM2020.0044ISI: 000580592900001PubMedID: 33032470Scopus ID: 2-s2.0-85092802276OAI: oai:DiVA.org:oru-86397DiVA, id: diva2:1475974
Available from: 2020-10-13 Created: 2020-10-13 Last updated: 2020-11-05Bibliographically approved

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Brummer, Robert Jan

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CiteExportLink to record
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