Dataset Information

Application of n-of-1 Clinical Trials in Personalized Nutrition Research: A Trial Protocol for Westlake N-of-1 Trials for Macronutrient Intake (WE-MACNUTR).

ABSTRACT: Personalized dietary recommendations can help with more effective disease prevention. This study aims to investigate the individual postprandial glucose response to diets with diverse macronutrient proportions at both the individual level and population level, and explore the potential of the novel single-patient (n-of-1) trial for personalization of diet. Secondary outcomes include individual phenotypic responses and the effects of dietary ingredients on the composition of gut microbiota. Westlake N-of-1 Trials for Macronutrient Intake is a multiple crossover feeding trial consisting of 3 successive 12-d dietary intervention pairs including a 6-d washout period before each 6-d isocaloric dietary intervention: a 6-d high-fat, low-carbohydrate diet, and a 6-d low-fat, high-carbohydrate diet. The results will help provide personalized dietary recommendations for macronutrients in terms of postprandial blood glucose responses. The proposed n-of-1 trial methods could help in optimizing individual health and advancing health care. This trial was registered with clinicaltrials.gov (NCT04125602).

SUBMITTER: Tian Y

PROVIDER: S-EPMC7494402 | biostudies-literature | 2020 Sep

REPOSITORIES: biostudies-literature

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Application of <i>n</i>-of-1 Clinical Trials in Personalized Nutrition Research: A Trial Protocol for Westlake N-of-1 Trials for Macronutrient Intake (WE-MACNUTR).

Tian Yunyi Y Ma Yue Y Fu Yuanqing Y Zheng Ju-Sheng JS

Current developments in nutrition 20200826 9

Personalized dietary recommendations can help with more effective disease prevention. This study aims to investigate the individual postprandial glucose response to diets with diverse macronutrient proportions at both the individual level and population level, and explore the potential of the novel single-patient (<i>n</i>-of-1) trial for personalization of diet. Secondary outcomes include individual phenotypic responses and the effects of dietary ingredients on the composition of gut microbiota ...[more]

PMID: 32968703

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Project description:Personalized and precision nutrition aim to examine and improve health on an individual level, and this requires reconsideration of traditional dietary interventions or behavioral study designs. The limited frequency of measurements in group-level human nutrition trials cannot be used to infer individual responses to interventions, while in behavioral studies, retrospective data collection does not provide an accurate measure of how everyday behaviors affect 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 an Ecological Momentary Assessment. Interventional designs can introduce a dietary or behavioral intervention with predictors and outcomes of interest measured repeatedly either during or after 1 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 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 changes in an individual or to aggregate data from sets of N-of-1 trials, enabling hypotheses to be tested on a small number of heterogeneous individuals. Although their designs necessitate extra methodological and statistical considerations, N-of-1 studies could be used to investigate complex research questions and to 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 an individual's health status.

Project description:BackgroundTo determine the efficacy of behavior change techniques applied in dietary and physical activity intervention studies, it is first necessary to record and describe techniques that have been used during such interventions. Published frameworks used in dietary and smoking cessation interventions undergo continuous development, and most are not adapted for Web-based delivery. The Food4Me study (N=1607) provided the opportunity to use existing frameworks to describe standardized Web-based techniques employed in a large-scale, internet-based intervention to change dietary behavior and physical activity.ObjectiveThe aims of this study were (1) to describe techniques embedded in the Food4Me study design and explain the selection rationale and (2) to demonstrate the use of behavior change technique taxonomies, develop standard operating procedures for training, and identify strengths and limitations of the Food4Me framework that will inform its use in future studies.MethodsThe 6-month randomized controlled trial took place simultaneously in seven European countries, with participants receiving one of four levels of personalized advice (generalized, intake-based, intake+phenotype-based, and intake+phenotype+gene-based). A three-phase approach was taken: (1) existing taxonomies were reviewed and techniques were identified a priori for possible inclusion in the Food4Me study, (2) a standard operating procedure was developed to maintain consistency in the use of methods and techniques across research centers, and (3) the Food4Me behavior change technique framework was reviewed and updated post intervention. An analysis of excluded techniques was also conducted.ResultsOf 46 techniques identified a priori as being applicable to Food4Me, 17 were embedded in the intervention design; 11 were from a dietary taxonomy, and 6 from a smoking cessation taxonomy. In addition, the four-category smoking cessation framework structure was adopted for clarity of communication. Smoking cessation texts were adapted for dietary use where necessary. A posteriori, a further 9 techniques were included. Examination of excluded items highlighted the distinction between techniques considered appropriate for face-to-face versus internet-based delivery.ConclusionsThe use of existing taxonomies facilitated the description and standardization of techniques used in Food4Me. We recommend that for complex studies of this nature, technique analysis should be conducted a priori to develop standardized procedures and training and reviewed a posteriori to audit the techniques actually adopted. The present framework description makes a valuable contribution to future systematic reviews and meta-analyses that explore technique efficacy and underlying psychological constructs. This was a novel application of the behavior change taxonomies and was the first internet-based personalized nutrition intervention to use such a framework remotely.Trial registrationClinicalTrials.gov NCT01530139; https://clinicaltrials.gov/ct2/show/NCT01530139 (Archived by WebCite at http://www.webcitation.org/6y8XYUft1).

Dataset Information

Application of n-of-1 Clinical Trials in Personalized Nutrition Research: A Trial Protocol for Westlake N-of-1 Trials for Macronutrient Intake (WE-MACNUTR).

Publications

Application of <i>n</i>-of-1 Clinical Trials in Personalized Nutrition Research: A Trial Protocol for Westlake N-of-1 Trials for Macronutrient Intake (WE-MACNUTR).

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