On the importance of intraindividual variation in nutritional research.

Abstract:

: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.

journal_name

Benef Microbes

journal_title

Beneficial microbes

authors

Larsen OFA,Claassen E,Brummer RJ

doi

10.3920/BM2020.0044

subject

Has Abstract

pub_date

2020-10-12 00:00:00

pages

511-517

issue

6

eissn

1876-2883

issn

1876-2891

journal_volume

11

pub_type

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