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

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.

Intervention(s) in this Clinical Trial

• Dietary Supplement: Placebo
  • Two capsules, twice daily with meals for 12 weeks.
• Dietary Supplement: Investigational Product 1
  • Two capsules, twice daily with meals for 12 weeks.
• Dietary Supplement: Investigational Product 2
  • Two capsules, twice daily with meals for 12 weeks.

Arms, Groups and Cohorts in this Clinical Trial

• Placebo Comparator: Placebo
• Experimental: Investigational Product 1
• Experimental: Investigational Product 2

Primary Measures

• Reduction in LDL levels
  • Time Frame: 0 weeks, 6 weeks, 12 weeks
    Safety Issue?: No

Secondary Measures

• Reduction in TG levels
  • Time Frame: 0 weeks, 6 weeks, 12 weeks
    Safety Issue?: No

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)

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 30 Years

Maximum Age for this Clinical Trial: 70 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: Accepts Healthy Volunteers

Lead Investigator: Nutrasource Diagnostics Inc. Other

Overall Clinical Trial Officials and Contacts

Maggie Laidlaw, Ph.D. Candidate Study Director Nutrasource Diagnostics Inc.  

Information obtained from ClinicalTrials.gov on February 09, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT01028274

Study ID Number: NN-91109

ClinicalTrials.gov Identifier: NCT01028274

Health Authority: Canada: Health Canada