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

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.

Sponsors

Lead Sponsor: Nordic Pharma, USA

Collaborator: Nutrasource Diagnostics Inc.

Source Nordic Pharma, USA
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.

Overall Status Completed
Start Date 2009-09-01
Completion Date 2010-08-01
Primary Completion Date 2010-06-01
Phase Phase 1/Phase 2
Study Type Interventional
Primary Outcome
Measure Time Frame
Reduction in LDL levels 0 weeks, 6 weeks, 12 weeks
Secondary Outcome
Measure Time Frame
Reduction in TG levels 0 weeks, 6 weeks, 12 weeks
Enrollment 148
Condition
Intervention

Intervention Type: Dietary Supplement

Intervention Name: Placebo

Description: Two capsules, twice daily with meals for 12 weeks.

Arm Group Label: Placebo

Intervention Type: Dietary Supplement

Intervention Name: Investigational Product 1

Description: Two capsules, twice daily with meals for 12 weeks.

Arm Group Label: Investigational Product 1

Other Name: Mfr. Product Code: 31214-NNM

Intervention Type: Dietary Supplement

Intervention Name: Investigational Product 2

Description: Two capsules, twice daily with meals for 12 weeks.

Arm Group Label: Investigational Product 2

Other Name: Mfr. Product Code: 31236-NNM

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 ®] - 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: All

Minimum Age: 30 Years

Maximum Age: 70 Years

Healthy Volunteers: Accepts Healthy Volunteers

Overall Official
Location
Facility: Nutrasource Diagnostics Inc.
Location Countries

Canada

Verification Date

2015-12-01

Responsible Party

Type: Sponsor

Keywords
Has Expanded Access No
Number Of Arms 3
Arm Group

Label: Placebo

Type: Placebo Comparator

Label: Investigational Product 1

Type: Experimental

Label: Investigational Product 2

Type: Experimental

Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Primary Purpose: Treatment

Masking: Triple (Participant, Investigator, Outcomes Assessor)

Source: ClinicalTrials.gov

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