Safety and Efficacy of a Natural Health Product in Reducing Cholesterol and Triglyceride Levels.

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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.

Conditions
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LDL Cholesterol, Triglycerides

Intervention / Treatment
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* Dietary Supplement: Placebo
* Dietary Supplement: Investigational Product 1
* Dietary Supplement: Investigational Product 2


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adults aged 30 - 70 years. 10-year CAD Risk <10% Elevated blood LDL cholesterol in the range of 3.0 to 5.0 mmol/L [equivalent to 117-195 mg/dl]. have elevated TG levels [1.5/L - 4.0mmol/L, or 134 mg/dl - 356 mg/dl]. 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®] Fluvastatin [brand names: Lescol®, Lescol® XL] Lovastatin [brand names: Advicor ®, Altocor ®, Altoprev ®, Mevacor ®] Pravastatin [brand names: Pravachol® , Pravigard® PAC] Rosuvastatin [brand name: Crestor®] Simvastatin [brand names: Vytorin®, Zocor ®] 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)

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br> | Dietary Supplement: Placebo<br>* Two capsules, twice daily with meals for 12 weeks.<br>* Other names: Mfr. Product Code: 31237-NNM;|
| Experimental: Investigational Product 1<br> | Dietary Supplement: Investigational Product 1<br>* Two capsules, twice daily with meals for 12 weeks.<br>* Other names: Mfr. Product Code: 31214-NNM;|
| Experimental: Investigational Product 2<br> | Dietary Supplement: Investigational Product 2<br>* Two capsules, twice daily with meals for 12 weeks.<br>* Other names: Mfr. Product Code: 31236-NNM;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reduction in LDL levels |  | 0 weeks, 6 weeks, 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reduction in TG levels |  | 0 weeks, 6 weeks, 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hypercholesterolemia, Hypertriglyceridemia, Fish Oil, Red Yeast Rice