LDL Cholesterol Clinical Trial
Official title:
Clinical Trial to Assess the Safety and Efficacy of a Combination Red Yeast Rice and Omega-3 (EPA+DHA) to Reduce LDL Cholesterol and Triglyceride Levels in Hypercholesterolemic and Hypertriglyceridemic Subjects.
The purpose of this study is to assess the safety and efficacy of a natural health product among participants with elevated LDL cholesterol and triglyceride levels.
Cardiovascular Disease [CVD] is one of the primary causes of illness, disability and death
in Canada and in the United States. Hypercholesterolemia and hypertriglyceridemia are
significant risk factors for the development of cardiovascular disease.
The investigational product used in this trial, has been specially formulated to help reduce
elevated triglycerides and LDL cholesterol levels, and may provide a natural alternative in
the prevention of CVD.
This study is a prospective, 12 week study, where participants will be randomized to receive
the treatment, placebo, or a comparator product for a period of 12 weeks. Blood lipids will
be analysed at baseline, week 6 and week 12.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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