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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
289
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.
Percent change in fasting blood circulating serum TGs
The percent change in fasting blood circulating serum TGs between baseline and 4 weeks of treatment.
Time frame: Between baseline and 4 weeks of treatment.
Absolute change in fasting plasma TGs
Absolute change in fasting plasma TGs;
Time frame: Baseline, Week 4 and Week 8
Patients achieving target TG fasting plasma levels
Percentage (%) of patients achieving target TG fasting plasma levels (TG\<1.7 mmol/L);
Time frame: Baseline
Change in fasting plasma LDL-C, VLDL-C, HDL-C, total cholesterol, hs-CRP and non-HDL
Absolute change in fasting plasma LDL-C, VLDL-C, HDL-C, total cholesterol, hs-CRP and non-HDL
Time frame: Between baseline and 4 and 8 weeks of treatment
Change in fasting plasma concentrations of LDL-C, VLDL-C, HDL-C, total cholesterol, hs-CRP and non-HDL
Percentage (%) change in fasting plasma concentrations of LDL-C, VLDL-C, HDL-C, total cholesterol, hs-CRP and non-HDL;
Time frame: Between baseline and 4 and 8 weeks of treatment
Calculated ratios
Calculated Ratios: 1. Total cholesterol : HDL-C 2. LDL-C : HDL-C 3. TGs : HDL-C
Time frame: The percent change in fasting blood circulating serum TGs Between baseline and 4 and 8 weeks of treatment.
Change in fasting plasma concentrations of biomarkers
Absolute and percent (%) change in fasting plasma concentrations of biomarkers; 1. Glycated Hemoglobin (HbA1c) 2. Glucose 3. Creatinine phosphokinase (CPK)
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Patient will be treated as per the Standard of care.
4 capsules of 1 g total per day for 8 weeks.
Alberta Health Services Clinical Trials
Red Deer, Alberta, Canada
Unnamed facility
Abbotsford British Columbia, British Columbia, Canada
Unnamed facility
Kelowna, British Columbia, Canada
BC Diabetes
Vancouver, British Columbia, Canada
Unnamed facility
Victoria, British Columbia, Canada
Unnamed facility
Winnipeg, Manitoba, Canada
Unnamed facility
Dieppe, New Brunswick, Canada
Entralogix Clinical Research
Aurora, Ontario, Canada
Entralogix Clinical Research
Brampton, Ontario, Canada
Cambridge Cardiac Care Center
Cambridge, Ontario, Canada
...and 28 more locations
Time frame: Between baseline and 4 and 8 weeks of treatment