Back

Nutraceutical Treatment of Cardiometabolic Disease and Disorders

Case Number: 15-104

Applications: Treatment of cardiometabolic disease and/or prevention of risk factors

Background: 

Chronic cardiometabolic disease is a prominent public health concern. Cardiometabolic disease is a collection of cardiovascular and metabolic conditions that collectively predispose individuals to stroke or heart attack (cardiovascular disease) or other disorders. While there are effective medical treatments available for certain cardiometabolic diseases, the incidence of these disorders remains high. An increased prevalence of obesity and other risk factors such as high blood pressure, high blood cholesterol and/or high blood sugar are responsible for the high incidence of cardiometabolic diseases. This nutraceutical has the potential to treat or prevent these diseases.

Technology:

UPEI-120 is a nutraceutical composed of apocynin, lipoic acid and berberine. It has been shown to treat or prevent cardiometabolic diseases or metabolic disorders. A 12-week human clinical trial showed significant improvements, including:

  • Decreased appetite 
  • Decrease in low density lipoprotein cholesterol (LDL-C)  from ~150 mg/dl to 100 mg/dl
  • Decrease in serum biomarkers of inflammation (PAI-1), diabetes and insulin resistance (Glutathione redox ratio and HOMA-IR)
  • A two-fold improvement in vascular function/reactivity (endothelia flow-mediated dilatation)

Trends in improvements were also observed in diastolic and systolic blood pressure, decreased weight, waist circumference and body fat during the 12-week trial.  These trends would likely reach significance if the trial continued for a longer duration.

Applications: Treatment of cardiometabolic disease and/or prevention of risk factors

Advantages:

  • Ready for market. 
  • The component compounds are commercially available. In the USA, the combination product could be launched under DSHEA regulations as a dietary supplement. In Canada, a regulatory dossier would need to be prepared and submitted to the NNHPD to obtain a NHPN to permit sales.
  • Only minor reformulation and/or packaging modifications are required to combine the different compounds into a single dosage form.
  • Potential for further development for obesity and hypertension indications. In addition to lowering lipid profiles the nutraceutical supplement can provide further health benefits in patients with cardiometabolic syndrome.
  • Reduced side effects. Synergistically combining two or more well tolerated, commercially available compounds enables a significant dose reduction (10 to 1000 fold) resulting in low side effect profiles.
  • Safe for patients who are ineligible for therapy with commercially available statin drugs.

Stage of Development: Completed a 12-week human clinical trial    

Patent Protection: A PCT Application has been filed (PCT/CA2013/000472).

Opportunity: Licensing
 

View Nutraceutical Treatment of Cardiometabolic Disease and Disorders 15-104 pdf