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Spherix Announces Positive Phase 2 Study Results
Date:6/24/2009

nt with any oral or injectable anti-diabetic treatment were excluded from the study, as well as any having one or more episodes of severe hypoglycemia within six months prior to entry into the study, or currently diagnosed as having hypoglycemia unawareness.

In this trial, Naturlose was safe and well tolerated. Low rates of treatment-related adverse events were noted at all doses. The most common adverse events reported in the trial were mild and gastrointestinal in nature.

Prior Studies with Naturlose

A recent controlled animal study demonstrated that, in comparison to sucrose, equivalent substitution of Naturlose as dietary carbohydrate results in less obesity, hyperglycemia, hyperlipidemia, and atherosclerosis (Police SB, Harris JC, Lodder RA, Cassis LA. Effect of diets containing sucrose vs. D-tagatose in hypercholesterolemic mice. Obesity. 2009 Feb;17(2):269-75.). A novel finding in this study was that atherosclerotic lesions detected in TAG-fed mice were composed of increased collagen, indicative of a more stable plaque phenotype. The results suggest that, in addition to minimizing the extent of atherosclerosis from carbohydrate consumption, a diet enriched in tagatose may favor a more stable plaque phenotype less likely to cause stroke or myocardial infarction.

Prior Clinical Trials with Naturlose

Eight healthy individuals and eight individuals with type 2 diabetes underwent separate 3-hour oral glucose and tagatose tolerance tests. The subjects were also given 75 g of tagatose followed 30 minutes later by 75 g of glucose. Between test days, participants received 10 g of tagatose per day. Ingestion of the tagatose load (75 g) caused no increase in plasma insulin or glucose concentrations in either healthy or diabetic individuals. (Donner TW, Wilber JF, Ostrowski D. D-Tagatose, a novel hexose: Acute effects on carbohydrate tolerance in subjects with
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SOURCE Spherix Incorporated
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