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Advances in Nutrition: an International Review Journal Application of N-of-1 methods in personalized nutrition research --Manuscript Draft-- Manuscript Number: ADVANCES-20-0451R2 Full Title: Application of N-of-1 methods in personalized nutrition research Short Title: N-of-1 methods in nutrition research Article Type: Perspective Keywords: N-of-1; precision nutrition; personalized nutrition; Ecological Momentary Assessment; self-report measures; study design; review Corresponding Author: Baukje de Roos University of Aberdeen Aberdeen, UNITED KINGDOM Corresponding Author Secondary Information: Corresponding Author's Institution: University of Aberdeen Corresponding Author's Secondary Institution: First Author: Baukje de Roos First Author Secondary Information: Order of Authors: Baukje de Roos Tilly Potter Rute Vieira Order of Authors Secondary Information: Abstract: Personalized and precision nutrition aim to examine and improve health on an individual level, and this requires reconsideration of traditional dietary intervention or behavioral study designs. The limited frequency of measurements in group-level human nutrition trials cannot be used to infer individual response to interventions, while in behavioral studies, retrospective data collection does not provide an accurate measure of how everyday behaviors affects individual health. This review introduces the concept of N-of-1 study designs, which involve the repeated measurement of a health outcome or behavior on an individual level. Observational designs can be used to monitor a participant’s usual health or behavior in a naturalistic setting, with repeated measurements conducted in ‘real time’ using Ecological Momentary Assessment. Interventional designs can introduce a dietary or behavioral intervention with predictors and outcomes of interest measured repeatedly during, or after, one or more intervention and control periods. Due to their flexibility, N-of-1 designs can be applied to both short-term physiological studies and longer-term studies of eating behaviors. As a growing number of disease markers can be measured outside of the clinic, with self-reported data being delivered via electronic devices, it is now easier than ever to generate large amounts of data on an individual level. Statistical techniques can be utilized to analyze change in single individuals, or aggregate data from sets of N-of-1 trials, enabling hypotheses to be tested on a small number of heterogeneous individuals. Although their design necessitates extra methodological and statistical considerations, N-of-1 studies could be used to investigate complex research questions and study underrepresented groups. This may help to reveal novel associations between participant characteristics and health outcomes, with repeated measures providing power and precision to accurately determine individual health status. Additional Information: Question Response Powered by Editorial Manager® and ProduXion Manager® from Aries Systems Corporation Manuscript Click here to access/download;Manuscript;N of 1 review_highlighted_07DEC2020.docx 1 Application of N-of-1 methods in personalized nutrition research 1 2 1 Tilly Potter , Rute Vieira , Baukje de Roos 1 Rowett Institute, University of Aberdeen 2 Institute of Applied Health Sciences, University of Aberdeen Corresponding author: Baukje de Roos Rowett Institute, University of Aberdeen, Foresterhill, Aberdeen AB25 2ZD +44 (0)1242 438636 b.deroos@abdn.ac.uk Wordcount: 6559 Number of figures: 4 Number of tables: 1 Running title: N-of-1 methods in nutrition research Funding: BBSRC-Unilever CTP PhD grant The authors report no conflicts of interest. 2 Abbreviations EMA Ecological Momentary Assessment RCT Randomized Controlled Trial SBP Systolic Blood Pressure 3 Abstract 1 Personalized and precision nutrition aim to examine and improve health on an individual level, 2 and this requires reconsideration of traditional dietary intervention or behavioral study designs. 3 The limited frequency of measurements in group-level human nutrition trials cannot be used to 4 infer individual response to interventions, while in behavioral studies, retrospective data 5 collection does not provide an accurate measure of how everyday behaviors affects individual 6 health. This review introduces the concept of N-of-1 study designs, which involve the repeated 7 measurement of a health outcome or behavior on an individual level. Observational designs 8 can be used to monitor a participant’s usual health or behavior in a naturalistic setting, with 9 repeated measurements conducted in ‘real time’ using Ecological Momentary Assessment. 10 Interventional designs can introduce a dietary or behavioral intervention with predictors and 11 outcomes of interest measured repeatedly during, or after, one or more intervention and control 12 periods. Due to their flexibility, N-of-1 designs can be applied to both short-term physiological 13 studies and longer-term studies of eating behaviors. As a growing number of disease markers 14 can be measured outside of the clinic, with self-reported data being delivered via electronic 15 devices, it is now easier than ever to generate large amounts of data on an individual level. 16 Statistical techniques can be utilized to analyze change in single individuals, or aggregate data 17 from sets of N-of-1 trials, enabling hypotheses to be tested on a small number of heterogeneous 18 individuals. Although their design necessitates extra methodological and statistical 19 considerations, N-of-1 studies could be used to investigate complex research questions and 20 study underrepresented groups. This may help to reveal novel associations between participant 21 characteristics and health outcomes, with repeated measures providing power and precision to 22 accurately determine individual health status. 23 Key words: N-of-1, precision nutrition, personalized nutrition, Ecological Momentary 24 Assessment, self-report measures, study design, review
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