Status and phase
Conditions
Treatments
About
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.
Full description
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.
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
Exclusion criteria
Adults aged less than 30, or more than 70 years of age
Adults with a 10-year CAD risk >10%
Individuals with a pre-existing disease or illness including: heart disease, diabetes, renal disease or cancer
Individuals taking CYP3A4 inhibitors [including cyclosporine and danazol].
Individuals taking Statin medications, including: Atorvastatin [brand names: Lipitor®, Caduet®]
Individuals with an allergy to fish and/or fish oil, Vitamin E, red yeast rice, coenzyme Q10, soybean oil or any other ingredient in the investigational product [i.e. capsule constituents]
Individuals who anticipate, or have planned surgery during the course of the trial
Individuals who are taking any other natural health products, particularly those containing vitamin K, high levels of vitamin E or Coenzyme Q10 [individuals on a 4-week wash-out of NHPs will be permitted]
Individuals who have consumed fish oil or another type of omega-3 fatty acid supplement one-month prior-to and/or during the course of the study
Women who are pregnant or breastfeeding
Individuals with a history of migraines
Individuals taking blood thinning, or blood pressure medications
Individuals who have been diagnosed with statin-induced muscle damage (myopathy)
Primary purpose
Allocation
Interventional model
Masking
148 participants in 3 patient groups, including a placebo group
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Data sourced from clinicaltrials.gov
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