4.1. Study Design
This study was designed as an acute, randomized, double-blind, three-arm, crossover, controlled trial. The sample size was determined to enable the detection of a 0.5 mM difference in maximal incremental blood glucose levels (iCmax) between groups, assuming 80% power with an alpha of 0.05. It was based on the results from a pilot study in a similar cohort with iCmax values of 2.69 ± 0.79 mmol/L and 2.16 ± 0.56 mmol/L in the control group and the intervention group (500 mg BSW), respectively. The selected dose levels of the extract were: (1) 500 mg, which was the dose tested in the pilot study and previously reported in clinical trials on 