Personalised REsponses to DIetary Composition Trial (PREDICT): an intervention study to determine inter-individual differences in postprandial response to foods

Abstract The Personalised REsponses to DIetary Composition Trial (PREDICT) was a single-arm, single-blind intervention study that utilized both standardized “test” meals and captured “free-living” non-standardized food consumption, to predict an individual’s metabolic response to foods based on the person’s characteristics (including their metabolomic and gut microbiome profiles), meal composition (macronutrients and energy content) and meal context (including time of day, sleep and exercise). The initial study commenced in June 2018 and targeted 1,000 generally healthy participants between the ages of 18 and 65 years for enrollment in the United Kingdom, and recruited from the existing and ongoing TwinsUK research cohort and the general population. In December 2018, an independent trial mirroring the UK protocol was launched in parallel at Massachusetts General Hospital to serve as a US-based validation cohort including 100 healthy individuals in the general population. The overall objective of these trials was to predict glucose, insulin, lipid and other postprandial responses to foods based on the individual’s characteristics, including molecular biomarkers and lifestyle factors as well as the nutritional composition of the food. The studies, collectively termed PREDICT 1, were completed in May 2019. The study has delivered highly-dimensional multi-omic data from which the predictors of individual postprandial responses have been determined. These findings will be used to design personalized dietary interventions focused on key health outcomes. This protocol is registered with the US National Institutes of Health trial registry, ClinicalTrials.gov: NCT03479866.