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.

Postprandial glycaemic dips predict appetite and energy intake in healthy individuals

“…The PREDICT 1 Cohort 1 study( 17 ) (Personalised REsponses to DIetary Composition Trial) was a two-centre study conducted between 2018 and 2019. The first participant was enrolled on 4 August 2018, the last clinical visit was completed on 24 April 2019, with the primary cohort based at King’s College London, UK, and a validation cohort (that underwent the same profiling as in the UK) assessed at Massachusetts General Hospital (MGH) in Boston, Massachusetts, USA.…”

“…The full study protocol is described by Berry ( 17 ). In brief, the study consisted of two phases: a 1-day clinical baseline visit which included a breakfast and lunch challenge followed by a 13-day at-home study phase.…”

“…For this study we focused only on the at home phase. During the at-home phase (days 2-14), participants consumed standardised breakfasts (including a repeat of the clinic breakfast and lunch meal, an OGTT and 6 isocaloric meals of which 5 were in duplicate) as described in the protocol ( 17 ), varying in macronutrient composition. Analyses of most primary outcomes have been described in ( 18 ).…”

Microbiome connections with host metabolism and habitual diet from 1,098 deeply phenotyped individuals

“…We performed a multi-national, single-arm (pre-post) intervention study of diet-microbiomecardiometabolic interactions, including a discovery cohort based in the United Kingdom (UK) and a validation population in the United States (US). The UK cohort recruited 1,002 generally healthy adults (non-twins, identical [monozygotic; MZ], and non-identical [dizygotic; DZ] twins) with detailed demographic information, quantitative habitual diet data, cardiometabolic blood biomarkers, and postprandial responses to both standardized test meals in the clinic and in free-living settings 17 (Fig. 1A).…”

“…Following the in-person clinic day, we also measured glucose concentrations via continuous glucose monitoring over the subsequent 13-day at-home period 17 that included responses to isocaloric standardized meals, in duplicate, with different macronutrient compositions (fat, carbohydrate, protein and fibre; Supplementary Table 3). However, contrary to our clinic meal responses (Fig.…”