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

LDL Cholesterol Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01028274
• Other study ID #: NN-91109
• Secondary ID: NHPD145265
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: December 8, 2009
• Last updated: December 10, 2015
• Start date: September 2009
• Est. completion date: August 2010

Study information

• Verified date: December 2015
• Source: Nordic Pharma, USA
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 148
• Est. completion date: August 2010
• Est. primary completion date: June 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 30 Years to 70 Years

Eligibility

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)

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• LDL Cholesterol
• Triglycerides

Intervention

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

Locations

Country	Name	City	State
Canada	Nutrasource Diagnostics Inc.	Guelph	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
Nordic Pharma, USA	Nutrasource Diagnostics Inc.

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reduction in LDL levels		0 weeks, 6 weeks, 12 weeks	No
Secondary	Reduction in TG levels		0 weeks, 6 weeks, 12 weeks	No