No Severe Adverse Effects Observed
MANCHESTER, NH -- (MARKETWIRE) -- 01/28/13 -- Boston Therapeutics, Inc. (OTCQB: BTHE) ("Boston Therapeutics" or "the Company"), a developer of complex carbohydrates to treat diabetes and inflammatory diseases, today announced the results of a clinical study conducted at the University of Sydney in Australia that showed the post-meal incremental area under the curve (iAUC) for glucose and insulin were significantly lower following consumption of SUGARDOWN® chewable dietary supplement tablets prior to a high carbohydrate meal of rice in a dose-dependent manner. This resulted in a reduction of up to 61% in post-meal elevation of blood glucose compared with the rice consumed alone. On average, there was a 32% reduction in the post-meal iAUC for glucose and a 24% reduction in post-meal insulin response for the 10 volunteers in the study. No severe adverse effects were reported or observed during the study.
"These study results demonstrate that SUGARDOWN® dietary supplement tablets can have a significant effect in reducing post-meal glucose and insulin responses," said David Platt, Ph.D., Chief Executive Officer, Boston Therapeutics. "Such a nutritional approach may be valuable in the management of blood sugar and could enhance the role of functional dietary supplements as part of a diabetes management plan."
SUGARDOWN® tablets data were collected for post-meal blood sugar elevation with a 50g glucose challenge. In a randomized, crossover design study, SUGARDOWN® was tested at two doses in 10 healthy, non-smoking subjects (6 males, 4 females; ages 25.6-36.8; BMI=25.5-28.7). After an overnight fast of at least 10 hours, subjects were randomized to one of three test meals. Each jasmine rice-based meal was served to subjects in a fixed portion containing 50 grams of available carbohydrate (from 63 grams dry weight rice) and 250ml of plain water. Each of the three test meals were consumed on two different visits by each subject, for a total of 6 test meals over 6 separate test sessions.
A total of eight blood samples were collected from each subject during a test session to measure both blood glucose and insulin levels. Finger-prick blood samples were taken at time -10, 0, 15, 30, 45, 60, 90 and 120 minutes, with time 0 corresponding to the start of rice consumption. For each time point, plasma glucose and insulin concentrations were determined, and the incremental area iAUC for each test meal was calculated; parametric statistical tests (repeated-measures ANOVA and the Fisher PLSD test) were used to determine whether there were any significant differences among the plasma glucose and insulin iAUC responses for each test meal.
SUGARDOWN® is a non-systemic chewable tablet designed to reduce post-meal elevation of blood glucose. SUGARDOWN® is a proprietary polysaccharide designed to be taken before meals and works in the gastrointestinal track to block the action of carbohydrate-hydrolyzing enzymes which break down carbohydrates into glucose and release them into the bloodstream.
About Boston Therapeutics, Inc.
Boston Therapeutics, headquartered in Manchester, NH, (OTCQB: BTHE) is a leader in the field of complex carbohydrates. The Company's initial product pipeline is focused on developing and commercializing therapeutic molecules for diabetes: SUGARDOWN®, a non-systemic chewable dietary supplement tablet designed to reduce the elevation in post-meal blood glucose; BTI-7, a new, chewable tablet formulation of the diabetes drug metformin hydrochloride; PAZ320, a non-systemic compound designed to reduce post-meal glucose elevation, and IPOXYN™, an injectable anti-necrosis drug specifically designed to treat lower limb ischemia associated with diabetes. More information is available at www.bostonti.com and www.sugardown.com.
FORWARD-LOOKING STATEMENTS: Any statements in this news release about future expectations, plans and prospects for the Company constitute forward-looking statements as defined in the "safe harbor" provisions of the Private Securities Litigation Reform Act of 1995. These forward-looking statements are based on management's current expectations and are subject to a number of factors and uncertainties, which could cause actual results to differ materially from those described in such statements.
More information about those risks and uncertainties is contained and discussed in the Company's most recent quarterly or annual report and in the Company's other reports filed with the Securities and Exchange Commission. The forward-looking statements represent the Company's views as of the date of this news release and should not be relied upon to represent the Company's views as of a subsequent date. While the Company anticipates that subsequent events may cause the Company's views to change, the Company disclaims any obligation to update such forward-looking statements.