Continuous glucose monitoring as a close to real life alternative to meal studies - a pilot study with a functional drink containing amino acids and chromium

Azat Samigullin, Per M Humpert, Elin Östman, Azat Samigullin, Per M Humpert, Elin Östman

Abstract

This pilot study aimed to evaluate a continuous glucose monitoring (CGM) based approach to study the effects of a functional drink containing specific amino acids and chromium picolinate (FD) and a combination of FD with a juice (FDJ) on postprandial glucose in a close to real life setting. The predefined primary endpoint for this study was the 120-min incremental area under the glucose curve (iAUC0-120min ) after meals. It was estimated that using CGM and repeated meals in 6 participants could be sufficient to match the power of the previous study in regards to the quantity of meals. Participants followed a pre-specified meal schedule over 9 days and consumed the drinks three times daily with main meals. Differences between drinks were analyzed by analysis of covariances (ANCOVA) with subject number and activity as random factors and nutrient composition as covariates. In 156 meals available for analysis, a significant 34% reduction of glucose iAUC0-120min was shown for FDJ (p < 0.001). FD did not show a significant effect on its own, but a significant reduction of 17.6% (p = 0.007) was shown in pooled data for FD and FDJ. While the differences between the two functional drinks used were not the primary focus of this study, it was sufficiently powered to detect previously described effects in 60 participants in a cross-over design under laboratory settings. The design presented defines a novel and cost-effective approach using CGM devices and app-based lifestyle tracking for studying nutritional effects on glucose at home in a close to real-life setting.

Keywords: amino acids (AAs); continuous glucose monitoring (CGM); dietary intervention glycemic control; dietary intervention randomized controlled trial; functional food (FF); glycemic index and glycemic load; meal study; postprandial glycemia.

Conflict of interest statement

This study received funding from Double Good AB. The funder had the following involvement with the study: EÖ is co-inventor of the patent family describing the functional drink studied, and works for Aventure AB/Double Good AB, that has a license to use the patent. starScience GmbH AS and PH have received funding for other studies by Aventure AB/Double Good AB. PH holds shares of Double Good AB. AS is employed by starScience GmbH.

Copyright © 2022 Samigullin, Humpert and Östman.

Figures

Figure 1
Figure 1
iAUC0−120 values adjusting for subject and physical activity in the 120 min before or after the beginning of a meal. Covariates appearing in the model are evaluated at the following values: total carbohydrates = 65.3 g, total protein = 21.3 g, total fats = 25.5 g. *p < 0.001.

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