SBIR/STTR Award attributes
Effects of Abscisic Acid on Insulin Sensitivity Biotherapeutics IncBTIa spinoff Company of Virginia Techis developing innovative products for personalized nutritionBTI has licensedpatent applications from Virginia Tech related to new methods of lowering blood sugar levels and suppressing inflammation during prediabetes and typediabetesincluding significant intellectual propertiesIPon the anti diabetic actions of abscisic acidABAWe developed an ABA extract from figsABAlifeTMand established ABA as a Generally Regarded as SafeGRASingredientSignificance andampProductPrediabetes afflictsmillion Americans and has recently risen to more thanmillion new cases per year in the U SaloneA prediabetic person is likely to become diabetic withinyearsbecause many people with prediabetes have no symptoms and do not adhere to lifestyle and diet changes or medical treatmentAccording to the CDCout ofAmericans with prediabetes don t know they have itDietary ABA supplementation is a safe and non toxic method to improve glycemic control in miceratsand humans with an effective dose as low asg kg and no side effectsThe goal of this Fast Track proposal is to develop ABA as a medical food ingredient for glycemic controlThe Specific Aims for the SBIR Fast Track Phase I application are toAIMValidate the mechanisms of action and cell specificity of dietary ABA in skeletal muscle ofmiceWe will investigate differential ABA induced LANCLsignaling in skeletal muscle cells duringdiabetesWe will employ LANCLconditional knockout animals to address ABA s cell specific effectsAIMCharacterize the potential for translation of LANCLdependent mechanism in humanprimary skeletal muscle cellsUnder ABA or vehicle treated conditionswith or without siRNA CRISPLANCLwe will assess GLUTtranslocationglucose uptake and oxidationand glycogen synthesisTransition Milestones areABA is dependent on muscle specific expression of LANCLand ABA induces increases in the uptake and metabolism of glucose in mice and ex vivo culture of primary human muscle cellsThe Specific Aims for the SBIR Fast Track Phase II application are toAIMPerform aday human clinical study in prediabetic subjects to assess the effects of ABAon glucose homeostasis and tolerabilityUsing a two grouprandomizedplacebo controlledcrossover trialwe will evaluate how ABAgtwice daily effects insulin sensitivity within skeletalmuscle by the hyperinsuliemiceuglycemic clampcombined with percutaneous muscle biopsies todirectly interrogate LANCLactivation and GLUTtranslocation in enhanced insulin sensitivtyCommercial ApplicationBTI will have generated claims for ABA in maintaining healthy glucose levelsABA products could disrupt the $ B medical foodB functional waterand $B diabetes markets byAbscisic acidABAhas demonstrated outstanding efficacy in improving glycemic controlbut even though its concentration in some fruits is highthe amount of ABA available in the normal diet alone fails to provide an effective control of blood sugar levelsGiven thatof adults in the U Shave metabolic syndromeobesityprediabetesor diabetesand they also have low levels of ABA in metabolic poolsan ABA containing medical food developed under this SBIR could address the overlying health problems of overmillion US consumers with a market exceeding $B annually byand could also disrupt the $ B medical foods andB functional water markets
