Evaluation of a novel supplement to reduce blood glucose through the use of a modified oral glucose tolerance test

Abstract

Elevated blood glucose is a major component in metabolic syndrome and pre-diabetes, sometimes leading to type 2 diabetes mellitus (DM II). Additionally, it may lead to adipose deposits when left elevated for long periods. The epidemiology of DM II clearly shows that uncontrolled blood glucose levels leads to many adverse conditions including heart disease, retinal damage, renal failure, erectile dysfunction, and other significant medical conditions. Here we conducted a single-center, prospective, randomized, double-blinded, placebo-controlled, parallel-group- clinical trial of a nutraceutical supplement vs. placebo to measure its glucose lowering effect in generally healthy adults before and after a simple sugars meal. Subjects reported to the test clinic on multiple days to receive placebo or treatment, a simple sugars meal, as well as pre-and postprandial blood glucose measurement (modified oral glucose tolerance test). Each subject served as his or her own control and thirty-one subjects completed the trial with at least one oral glucose tolerance test (OGTT) with the nutraceutical supplement and placebo. Statistical analysis revealed the nutraceutical supplement significantly lowered postprandial glucose levels by 36% and 59% at 45 and 60 minutes, respectively (***P<.001). The study was limited by its composition of primarily overweight females. Future studies will be required over longer periods in more heterogeneous and larger groups to determine the long-term effect of this supplement on blood glucose levels in terms of prophylaxis or treatment for DM II.

Keywords: Glucose tolerance test; diabetes mellitus II; diet; hyperglycemia; insulin resistance; nutraceutical supplement.

Figure 1

Clinical trial flow chart.

Figure 2

Oral supplement dampens rise in blood glucose. To assess the effectiveness of the supplement for reducing blood glucose following a simple sugars challenge, the change in blood glucose was calculated so that each subject served as his or her own control. Within subject testing revealed that the data conform to a quadratic model (F=177.9). Data is presented as mean change ± SEM at each time point Post-hoc analysis of two-tailed t-tests at each time point revealed statistical significance (*P<.05, **P<.01, ***P<.001) att=30, 45, and 60 minutes.

Figure 3

Oral supplement lowers total blood glucose load: (A) The mean blood glucose levels (mg/dL) and standard error of the mean (SEM) for placebo vs. supplement at time points from 0-60 min indicate a statistical significance at t= 60 minutes (*P<.05). (B) To better illustrate the observed decrease in blood glucose levels, the area under curve (AUC) values were calculated for each subject ± SEM. Administration of the supplement prior to the test meal resulted in a 39% reduction in the area under the curve (AUC) over the 60-minute test period (***P<.001).