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.
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- LDL Cholesterol
- Sponsor
- Nordic Pharma, USA
- Enrollment
- 148
- Locations
- 1
- Primary Endpoint
- Reduction in LDL levels
- Status
- Completed
- Last Updated
- 10 years ago
Overview
Brief Summary
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
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.
Investigators
Eligibility Criteria
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 \[brand names: Vytorin®, Zocor ®\]
Outcomes
Primary Outcomes
Reduction in LDL levels
Time Frame: 0 weeks, 6 weeks, 12 weeks
Secondary Outcomes
- Reduction in TG levels(0 weeks, 6 weeks, 12 weeks)