NCT01028274

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.

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 148 (actual)
• Sponsor: Nordic Pharma, USA · Industry
• Sex: All
• Age: 30 Years – 70 Years
• Healthy volunteers: Accepted

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.

Conditions

• LDL Cholesterol
• Triglycerides

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2009-09-01
• Primary completion: 2010-06-01
• Completion: 2010-08-01
• First posted: 2009-12-09
• Last updated: 2015-12-14

Locations

1 site across 1 country: Canada