Boston Therapeutics’ sugardown(R) In Clinical Trials Reduces Glucose, Fructose And Insulin

NEWTON, MA--(Marketwired - December 29, 2015) -

Boston Therapeutics, Inc. (OTCQB: BTHE) released final trial results from its proof of concept (POC) Sydney University study that showed consumption of sugardown® tablets prior to sugary beverages was found to significantly reduce the postprandial glucose, fructose and insulin responses to the sugary soft drink beverage. Every subject had a favorable response. Specifically, two sugardown® tablets were found to reduce glucose levels (and by association fructose exposure) by up to 20 percent and the insulin response by up to 14 percent. Four sugardown® tablets were found to reduce total glucose levels by up to 28 percent and insulin response by up to18 percent. The study results indicate an average reduction in glycemic index (GI) an important measure of healthy nutritional management of approximately 10 percent following soft drink consumption with two sugardown® tablets.

David Platt, Ph.D., Chief Executive Officer of Boston Therapeutics, said, “The clinical study results provide confirming support that sugardown® can be effective in reducing glucose, (fructose by implication) and insulin response when consumed with sugary beverages. Sucrose and HFC, high fructose corn syrup, are a combination of glucose and fructose and preventing the breakdown is an important healthy diet management tool. The consumption of sugary soft drink beverages can lead to a wide range of health problems that through glycemic index management can delay or reduce ill effects and poor health, including obesity, type 2 diabetes, fatty liver disease, high blood pressure, and even brain and cognitive disorders. All of which have been implicated in animal models. We will add the clinical data on sugardown®'s effects on sugary beverages as a section in our regulatory submissions. We believe these additional clinical data continue to be supportive of sugardown® benefits as a dietary supplement classification. These clinical data will aid people with managing and reducing their overall systemic exposure to sugar after every meal.”

The single-center, randomized, controlled, crossover study was conducted at Sydney University’s Glycemic Index Research Service (SUGiRS) and co-sponsored by Boston Therapeutics and Sugardown® Co Ltd (Hong Kong) the China affiliate and alliance partner of Boston Therapeutics Inc.

The Study: A total of 10 healthy, high body mass index adults were enrolled. The evaluation was independently carried out by SUGiRS and is validated through the results from thousands of reference foods and glucose directly. The evaluation was carried out through the well documented use of subjects who were administered three test portions: a serving of ‘soft drink’ containing 50 grams of carbohydrate; an equal portion of ‘soft drink’ with two sugardown® tablets; and an equal portion of ‘soft drink’ with four sugardown® tablets. Blood samples were collected at regular intervals both before and after first ingestion of the soft drink. Each subject completed a total of six test sessions over four weeks. The primary outcomes of the study were postprandial incremental glucose area under the curve (iAUC) and postprandial incremental insulin area under the curve response. These evaluations are directly compared to glucose load response.

Glycemic Index (GI) represents the rise rush of available sugar in a person’s blood sugar level following consumption of a food or drink. Blood samples are used to construct a blood sugar response curve for a period of time following consumption. This time is critical to reducing the amplitude of the rise in sugar. If spread over several hours, one may consume sugar with no excursions outside the normal ranges and the HbA1c will not be increased. The Area Under the Curve (iAUC) over a defined period is calculated to reflect the rise (load) in blood glucose levels after eating the test food. The GI value is calculated by dividing the iAUC for a test food by the iAUC for a reference food. In this case it is directly measured to a glucose load and multiplied by 100. The average of the GI ratings from all subjects tested is published as the GI for that food.

sugardown®
sugardown® in its present formulation is a natural sugar blocker dietary supplement product made entirely from an non-digestible sugar molecule that can help people maintain healthier weight levels and is the first chewable tablet of its kind. In a previous study, sugardown® demonstrated significant reduction of glucose and insulin Area Under the Curve (AUC) when taken with rice, a food with a 100 percent glycemic index. Sugary soft drinks that also have high glycemic index, include sucrose and maltose which is also found in beer. More information can be found on www.sugardown.com

According to the U.S. Centers for Disease Control and Prevention (CDC), one-half of the U.S. population consumes sugar drinks on any given day, and 25 percent consumes at least 200 kcal (more than one 12-oz can of cola). Each can of Cola that is non-diet may contain over 36 teaspoons of sugar, an amount that is three times the daily limit recommended by the American Heart Association in it recent guidance regarding sugar consumption. The CDC reports that sugar drinks have been linked to poor diet quality, weight gain, obesity, and, in adults, type 2 diabetes.

About Sugardown® Co Ltd
Sugardown® Co Ltd (Hong Kong) is an affiliate of Advance Pharmaceuticals Company (APC), organized under the laws of Hong Kong. Boston Therapeutics has entered into an agreement with APC to develop markets for sugardown® in Hong Kong, China and Macau in addition to 12 other countries in Asia. Boston Therapeutics Inc. is currently conducting additional clinical trial with sugardown® in Hong Kong and mainland China.

Sydney University Glycemic Index Research Service (SUGiRS)
Sydney University GI Research Service (SUGiRS) was established in 1995 to provide a reliable commercial GI testing laboratory for the local and international food industry. Foods are tested in healthy volunteers according to standardized methods that have been validated against laboratories overseas. Insulin, satiety, hunger and other parameters can be assessed simultaneously. SUGiRS has an established reputation for quality, speed and flexibility. We can work with your company to develop new low GI products or help lower the GI of existing ones. Foods that meet nutrition guidelines and have been GI tested can carry the GI symbol (www.gisymbol.com).

About Boston Therapeutics, Inc.
Boston Therapeutics, headquartered in Newton MA, (OTCQB: BTHE) is an innovator in designing compounds using complex carbohydrate chemistry. The company’s product pipeline is focused on developing and commercializing therapeutic molecules that address diabetes and inflammatory diseases, including: BTI-320, a non-systemic chewable therapeutic compound designed to reduce HbA1C, and IPOXYN, an injectable anti-necrosis drug designed initially to treat lower limb ischemia associated with diabetes. The company also developed and markets sugardown®, a sugar blocker dietary food supplement designed to support glycemic health. More information is available at www.bostonti.com

Cautionary Note Regarding Forward Looking Statements
This press release contains, in addition to historical information, forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These statements relate to future events or future financial performance, and use words such as “may,” “estimate,” “could,” “expect” and others. They are based on our current expectations and are subject to factors and uncertainties which could cause actual results to differ materially from those described in the statements. Factors that could cause our actual performance to differ materially from those discussed in the forward-looking statements include, among others that our plans, expectations and goals regarding our clinical development of BTI-320 are subject to factors beyond our control. We can provide no assurance we or our commercial partner will be able to generate market demand for sugardown®, and thus we may not be able to generate revenue from sugardown® sales.

Moreover, we have incurred operating losses since our inception, and our ability to successfully develop, market, manufacture, distribute and sell drugs or over-the-counter products may be affected by our ability to manage costs and finance our continuing operations. For a discussion of additional risk and other factors affecting our business, see our Annual Report on Form 10-K for the year ended December 31, 2014, and our subsequent filings with the SEC.

You should not place undue reliance on forward-looking statements, and actual results may differ materially from the results anticipated in our forward-looking statements. Although subsequent events may cause our views to change, we disclaim any obligation to update forward-looking statements.

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