Safety and Efficacy of a Natural Health Product in Reducing Cholesterol and Triglyceride Levels.
NCT ID: NCT01028274
Last Updated: 2015-12-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1/PHASE2
148 participants
INTERVENTIONAL
2009-09-30
2010-08-31
Brief Summary
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Detailed Description
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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
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Placebo
Placebo
Two capsules, twice daily with meals for 12 weeks.
Investigational Product 1
Investigational Product 1
Two capsules, twice daily with meals for 12 weeks.
Investigational Product 2
Investigational Product 2
Two capsules, twice daily with meals for 12 weeks.
Interventions
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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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 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)
30 Years
70 Years
ALL
Yes
Sponsors
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Nutrasource Pharmaceutical and Nutraceutical Services, Inc.
NETWORK
Nordic Pharma, USA
INDUSTRY
Responsible Party
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Principal Investigators
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Maggie Laidlaw, Ph.D. Candidate
Role: STUDY_DIRECTOR
Nutrasource Pharmaceutical and Nutraceutical Services, Inc.
Brad West, ND
Role: STUDY_CHAIR
Nordic Naturals
Steven Traplin, MD
Role: PRINCIPAL_INVESTIGATOR
Nutrasource Pharmaceutical and Nutraceutical Services, Inc.
Locations
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Nutrasource Diagnostics Inc.
Guelph, Ontario, Canada
Countries
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Other Identifiers
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NHPD145265
Identifier Type: -
Identifier Source: secondary_id
NN-91109
Identifier Type: -
Identifier Source: org_study_id