A Randomized, Double-blind, Active-controlled, Cross-over Study to Assess the Effect of the Sugar Substitute "ENSO 16" on Glucose Metabolism Parameters in Healthy Subjects

The objective of this study is to evaluate differences in glucose metabolism parameters after oral administration of 30g glucose or 30g ENSO16. Blood samples will be be collected from 15 male or female subjects at defined time points (0 - 15 - 30 - 45 - 60 - 90 - 120
- 180 minutes; 3 min at each time point). Individual plasma glucose, insulin and C-peptide concentrations are going to be evaluated and statistically assessed. Subjects will also be asked to complete a questionnaire regarding their digestion after oral intake of ENSO 16 or glucose defined timepoints.

Start Date28 Apr 2022

Sponsor / Collaborator

Alpha Republic GmbH

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100 Clinical Results associated with ENSO-16

100 Translational Medicine associated with ENSO-16

100 Patents (Medical) associated with ENSO-16

Literatures (Medical) associated with ENSO-16

Scientific Reports

The substitute ENSO 16 has low impact on glucose metabolism in healthy humans: a randomized, double-blind, active-controlled, cross-over trial

Article

Author: Mussbacher, Lena M ; Lutnik, Martin ; Wolzt, Michael ; Weisshaar, Stefan ; Steiner, Daniel

AbstractHigh sugar consumption is associated with cardiovascular diseases and diabetes. Current sugar substitutes may cause taste sensations and gastrointestinal symptoms. ENSO 16 is a combination of 16 different sugar substitutes and plant fibers and has been designed as a sugar alternative. The impact on plasma glucose metabolism as well as on gastrointestinal tolerance has not been investigated yet. 17 healthy participants were enrolled in this randomized, double-blind trial. Participants received a single oral dose of 30 g glucose or 30 g ENSO 16 and crossed over to the alternate treatment after a 7 day wash out period. The study endpoint was the effect on plasma glucose, insulin, C-peptide concentrations and gastrointestinal disorders. A questionnaire regarding gastrointestinal symptoms was used for individual subjective scoring. The mean baseline adjusted plasma glucose AUC0–180 min was significantly greater after glucose administration compared to ENSO 16 (n = 15, p = 0.0128, paired t-test). Maximum plasma glucose elevation over baseline was 117 mg*dl−1 and 20 mg*dl−1 after oral glucose or ENSO 16, respectively. Insulin and C-peptide AUC0−180 min were significantly greater after glucose compared to ENSO 16 intake (p < 0.01, Wilcoxon rank sum test). The mean maximal concentrations of plasma glucose, insulin and C-peptide after glucose intake were 1.5, 4.6 and 2.7-fold greater after glucose intake compared to ENSO 16 intake, respectively. Adverse reactions were mostly mild and not different between treatments. Conclusion. ENSO 16 has only a small impact on plasma glucose metabolism. This may be of interest in a dietary context and may help to reduce calory intake.Trail registration NCT05457400. First registration: 14/07/2022. https://clinicaltrials.gov/study/NCT05457400.

100 Deals associated with ENSO-16

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