Assess the Safety and Efficacy of NKPL66 (CaPre™) in the Treatment of Mild-to-high Hypertriglyceridemia
Condition: Hypertriglyceridemia
MeSH terms: Hypertriglyceridemia
Study type: Interventional
Phase: Phase 2

Summary: 
      To evaluate the efficacy of 0.5, 1.0, 2.0 and 4.0 g/ day of CaPre™ in reducing fasting plasma
      serum triglycerides over a four week period in patients with mild-to-high
      hypertriglyceridemia as compared to the standard of care alone.
    

Detailed description: 
      The data generated from preclinical studies, as well as data accumulated from preclinical and
      clinical studies conducted with the precursor of CaPre™, NKO® , a natural health product
      (NPN: 80006416), have shown that CaPre™ is a safe product and well tolerated. In addition,
      there are preclinical data demonstrating that CaPre™ is effective in reducing circulating
      plasma concentrations of triglycerides. This effect is also accompanied by the regulation of
      other blood lipids, glucose tolerance and inflammatory biomarkers. These studies have been
      conducted in several preclinical adult phenotypes: (1) Healthy Sprague-Dawley (SD) rats, (2)
      obese and dyslipidemic Zucker Diabetic Fatty (ZDF) rats and(3-5) in three distinct murine
      phenotypes (normal wild-type C57BL/6, human ApoA-I transgenic mice and homozygous
      LDL-receptor knockout).

      As the prevalence of cardiometabolic disorders progressively increase over the years, it is
      expected that there will be an augmentation in the necessity for new anti-dyslipidemic
      medications that can most importantly be added in combination to other treatments. Current
      treatment methods address a specific target indication, but do not offer complete management
      of dyslipidemia.

      We are now left with the option to either inadequately treat patients suffering from
      cardiovascular and metabolic disorders or, to prescribe combination treatments hoping to
      address the risk factors while mitigating their known side effects. A treatment gap exists
      since there is no medication that increases HDL-cholesterol and reduces triglycerides while
      reducing LDL-cholesterol without side effects.

      At present there is a need to assess the effectiveness of CaPre™ in reducing triglycerides in
      patients with high hypertriglyceridemia. The current study will address these issues and will
      generate the evidence that will be required to determine whether this product could be
      effectively used in the clinical management of this patient population.
    

Intervention name(s): CaPre™; CaPre™; CaPre™; Lipid Lowering Medication; CaPre™
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement; Drug; Dietary Supplement
Intervention description(s): 1 capsule of 0.5g total CaPre™ for 4 weeks followed by one 1.0g capsule per day for an additional 4 weeks; 1 capsule of 1.0g total CaPre™ for 4 weeks followed by two 1.0g capsules per day for an additional 4 weeks; 2 capsules of 1.0g total CaPre™ for 4 weeks followed by 4 capsules of 1.0g total per day for an additional 4 weeks.; Patient will be treated as per the Standard of care.; 4 capsules of 1 g total per day for 8 weeks.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Hypertriglyceridemia