Clinical trial NCT01028274: 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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: LDL Cholesterol
Triglycerides
Keywords: Hypercholesterolemia
Hypertriglyceridemia
Fish Oil
Red Yeast Rice
Lead sponsor: Nordic Pharma, USA
Sponsor class: INDUSTRY
Collaborators: name: Nutrasource Pharmaceutical and Nutraceutical Services, Inc.
First posted: 2009-12-09
Enrollment: 148
Sex: ALL
Minimum age (years): 30
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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)

Primary outcomes:
measure: Reduction in LDL levels
timeFrame: 0 weeks, 6 weeks, 12 weeks
Secondary outcomes:
measure: Reduction in TG levels
timeFrame: 0 weeks, 6 weeks, 12 weeks
Other outcomes:
Locations:
city: Guelph
country: Canada
facility: Nutrasource Diagnostics Inc.
state: Ontario
Study officials:
affiliation: Nutrasource Pharmaceutical and Nutraceutical Services, Inc.
name: Maggie Laidlaw, Ph.D. Candidate
role: STUDY_DIRECTOR
affiliation: Nordic Naturals
name: Brad West, ND
role: STUDY_CHAIR
affiliation: Nutrasource Pharmaceutical and Nutraceutical Services, Inc.
name: Steven Traplin, MD
role: PRINCIPAL_INVESTIGATOR
References: