NCT01028274

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
148

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Sep 2009

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2009

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

December 8, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 9, 2009

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2010

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2010

Completed
Last Updated

December 14, 2015

Status Verified

December 1, 2015

Enrollment Period

9 months

First QC Date

December 8, 2009

Last Update Submit

December 10, 2015

Conditions

LDL CholesterolTriglycerides

Keywords

HypercholesterolemiaHypertriglyceridemiaFish OilRed Yeast Rice

Outcome Measures

Primary Outcomes (1)

  • Reduction in LDL levels

    0 weeks, 6 weeks, 12 weeks

Secondary Outcomes (1)

  • Reduction in TG levels

    0 weeks, 6 weeks, 12 weeks

Study Arms (3)

Placebo

PLACEBO COMPARATOR
Dietary Supplement: Placebo

Investigational Product 1

EXPERIMENTAL
Dietary Supplement: Investigational Product 1

Investigational Product 2

EXPERIMENTAL
Dietary Supplement: Investigational Product 2

Interventions

PlaceboDIETARY_SUPPLEMENT

Two capsules, twice daily with meals for 12 weeks.

Also known as: Soybean Oil, Mfr. Product Code: 31237-NNM
Placebo
Investigational Product 1DIETARY_SUPPLEMENT

Two capsules, twice daily with meals for 12 weeks.

Also known as: Mfr. Product Code: 31214-NNM
Investigational Product 1
Investigational Product 2DIETARY_SUPPLEMENT

Two capsules, twice daily with meals for 12 weeks.

Also known as: Mfr. Product Code: 31236-NNM
Investigational Product 2

Eligibility Criteria

Age30 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adults aged 30 - 70 years.
  • 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 \[1.5/L - 4.0mmol/L, or 134 mg/dl - 356 mg/dl\].

You may not qualify if:

  • 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
  • +3 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nutrasource Diagnostics Inc.

Guelph, Ontario, N1G0B4, Canada

Location

MeSH Terms

Conditions

HypercholesterolemiaHypertriglyceridemia

Interventions

Soybean Oil

Condition Hierarchy (Ancestors)

HyperlipidemiasDyslipidemiasLipid Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Dietary Fats, UnsaturatedDietary FatsFatsLipidsFats, UnsaturatedPlant OilsOilsPlant PreparationsBiological ProductsComplex MixturesFoodDiet, Food, and NutritionPhysiological PhenomenaFood and Beverages

Study Officials

  • Maggie Laidlaw, Ph.D. Candidate

    Nutrasource Pharmaceutical and Nutraceutical Services, Inc.

    STUDY DIRECTOR

  • Brad West, ND

    Nordic Naturals

    STUDY CHAIR

  • Steven Traplin, MD

    Nutrasource Pharmaceutical and Nutraceutical Services, Inc.

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 8, 2009

First Posted

December 9, 2009

Study Start

September 1, 2009

Primary Completion

June 1, 2010

Study Completion

August 1, 2010

Last Updated

December 14, 2015

Record last verified: 2015-12

Locations

CA(1)