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.

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.

Study Overview

• Status: Completed
• Conditions: Triglycerides; LDL Cholesterol
• Intervention / Treatment: Dietary supplement: Placebo; Dietary supplement: Investigational Product 1; Dietary supplement: Investigational Product 2

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.

• Study Type: Interventional
• Enrollment (Actual): 148
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Guelph, Ontario, Canada, N1G0B4
      • Nutrasource Diagnostics Inc.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 70 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: TRIPLE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
PLACEBO_COMPARATOR: Placebo	Dietary supplement: Placebo; Two capsules, twice daily with meals for 12 weeks.; Other Names: Soybean Oil; Mfr. Product Code: 31237-NNM
EXPERIMENTAL: Investigational Product 1	Dietary supplement: Investigational Product 1; Two capsules, twice daily with meals for 12 weeks.; Other Names: Mfr. Product Code: 31214-NNM
EXPERIMENTAL: Investigational Product 2	Dietary supplement: Investigational Product 2; Two capsules, twice daily with meals for 12 weeks.; Other Names: Mfr. Product Code: 31236-NNM

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Reduction in LDL levels	0 weeks, 6 weeks, 12 weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
Reduction in TG levels	0 weeks, 6 weeks, 12 weeks

Collaborators and Investigators

• Sponsor: Nordic Pharma, USA
• Collaborators: Nutrasource Pharmaceutical and Nutraceutical Services, Inc.
• Investigators: Study Director: Maggie Laidlaw, Ph.D. Candidate, Nutrasource Pharmaceutical and Nutraceutical Services, Inc.; Study Chair: Brad West, ND, Nordic Naturals; Principal Investigator: Steven Traplin, MD, Nutrasource Pharmaceutical and Nutraceutical Services, Inc.

Study record dates

Study Major Dates

• Study Start: September 1, 2009
• Primary Completion (ACTUAL): June 1, 2010
• Study Completion (ACTUAL): August 1, 2010

Study Registration Dates

• First Submitted: December 8, 2009
• First Submitted That Met QC Criteria: December 8, 2009
• First Posted (ESTIMATE): December 9, 2009

Study Record Updates

• Last Update Posted (ESTIMATE): December 14, 2015
• Last Update Submitted That Met QC Criteria: December 10, 2015
• Last Verified: December 1, 2015

More Information

Terms related to this study

• Keywords: Hypercholesterolemia; Fish Oil; Hypertriglyceridemia; Red Yeast Rice
• Other Study ID Numbers: NN-91109; NHPD145265