Individual Postprandial Glycemic Responses to Diet in n-of-1 Trials: Westlake N-of-1 Trials for Macronutrient Intake (WE-MACNUTR)

Abstract

Background The role of different types and quantities of macronutrients on human health has been controversial, and the individual response to dietary macronutrient intake needs more investigation. Objectives We aimed to use an ‘n-of-1’ study design to investigate the individual variability in postprandial glycemic response when eating diets with different macronutrient distributions among apparently healthy adults. Methods Thirty apparently healthy young Chinese adults (women, 68%) aged between 22 and 34 y, with BMI between 17.2 and 31.9 kg/m2, were provided with high-fat, low-carbohydrate (HF-LC, 60–70% fat, 15–25% carbohydrate, 15% protein, of total energy) and low-fat, high-carbohydrate (LF-HC, 10–20% fat, 65–75% carbohydrate, 15% protein) diets, for 6 d wearing continuous glucose monitoring systems, respectively, in a randomized sequence, interspersed by a 6-d wash-out period. Three cycles were conducted. The primary outcomes were the differences of maximum postprandial glucose (MPG), mean amplitude of glycemic excursions (MAGE), and AUC24 between intervention periods of LF-HC and HF-LC diets. A Bayesian model was used to predict responders with the posterior probability of any 1 of the 3 outcomes reaching a clinically meaningful difference. Results Twenty-eight participants were included in the analysis. Posterior probability of reaching a clinically meaningful difference of MPG (0.167 mmol/L), MAGE (0.072 mmol/L), and AUC24 (13.889 mmol/L·h) between LF-HC and HF-LC diets varied among participants, and those with posterior probability >80% were identified as high-carbohydrate responders (n = 9) or high-fat responders (n = 6). Analyses of the Bayesian-aggregated n-of-1 trials among all participants showed a relatively low posterior probability of reaching a clinically meaningful difference of the 3 outcomes between LF-HC and HF-LC diets. Conclusions N-of-1 trials are feasible to characterize personal response to dietary intervention in young Chinese adults.

The Relationship between Macronutrient Distribution and Type 2 Diabetes in Asian Indians

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Genetically-Guided Medical Nutrition Therapy in Type 2 Diabetes Mellitus and Pre-diabetes: A Series of n-of-1 Superiority Trials

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Breaking new frontiers: Assessment and re-evaluation of clinical trial design for nutraceuticals

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