Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

This study has been completed.
Sponsor:
Collaborator:
Nordic Naturals
Information provided by (Responsible Party):
Nutrasource Diagnostics Inc.
ClinicalTrials.gov Identifier:
NCT01028274
First received: December 8, 2009
Last updated: March 23, 2012
Last verified: March 2012
  Purpose

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.


Condition Intervention Phase
LDL Cholesterol
Triglycerides
Dietary Supplement: Placebo
Dietary Supplement: Investigational Product 1
Dietary Supplement: Investigational Product 2
Phase 1
Phase 2

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

Resource links provided by NLM:


Further study details as provided by Nutrasource Diagnostics Inc.:

Primary Outcome Measures:
  • Reduction in LDL levels [ Time Frame: 0 weeks, 6 weeks, 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Reduction in TG levels [ Time Frame: 0 weeks, 6 weeks, 12 weeks ] [ Designated as safety issue: No ]

Enrollment: 148
Study Start Date: September 2009
Study Completion Date: August 2010
Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: Mfr. Product Code: 31214-NNM
Experimental: Investigational Product 2 Dietary Supplement: Investigational Product 2
Two capsules, twice daily with meals for 12 weeks.
Other Name: Mfr. Product Code: 31236-NNM

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

Ages Eligible for Study:   30 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01028274

Locations
Canada, Ontario
Nutrasource Diagnostics Inc.
Guelph, Ontario, Canada, N1G0B4
Sponsors and Collaborators
Nutrasource Diagnostics Inc.
Nordic Naturals
Investigators
Study Director: Maggie Laidlaw, Ph.D. Candidate Nutrasource Diagnostics Inc.
Study Chair: Brad West, ND Nordic Naturals
Principal Investigator: Steven Traplin, MD Nutrasource Diagnostics Inc.
  More Information

No publications provided

Responsible Party: Nutrasource Diagnostics Inc.
ClinicalTrials.gov Identifier: NCT01028274     History of Changes
Other Study ID Numbers: NN-91109, NHPD145265
Study First Received: December 8, 2009
Last Updated: March 23, 2012
Health Authority: Canada: Health Canada

Keywords provided by Nutrasource Diagnostics Inc.:
Hypercholesterolemia
Hypertriglyceridemia
Fish Oil
Red Yeast Rice

Additional relevant MeSH terms:
Red yeast rice
Anticholesteremic Agents
Antimetabolites
Enzyme Inhibitors
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Hypolipidemic Agents
Lipid Regulating Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on November 19, 2014