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Efficacy Study of Daily Pro-Omega LDL for Low-Density Lipoprotein Cholesterol and Triglyceride Reduction (PrOteCT)

Primary Purpose

Mixed Hyperlipoproteinemia

Status
Withdrawn
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Pro-Omega LDL
Placebo
Sponsored by
Nordic Pharma, USA
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Mixed Hyperlipoproteinemia focused on measuring low density lipoprotein cholesterol, triglycerides, mixed hyperlipoproteinemia, Dehydroascorbic Acid, Eicosapentaenoic Acid, Fish oil

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Men or women, ≥18 years of age.
  • History (>3months) of LDL-C ≥130 mg/dl to ≤190 mg/dL
  • Triglycerides (TG) > 200 to <750 mg/dL
  • Able to understand and cooperate with study procedures, and have signed a written informed consent prior to any study procedures.
  • Willing to maintain a stable diet and level of activity throughout the trial. Willing to maintain current activity level and diet throughout the trial.
  • If, of childbearing age, must be on a medically approved form of birth control as identified by the investigator in this trial
  • History (> 3 months) of taking a statin medication (HMG-CoA reductase inhibitor, including Lipitor, Zocor, Crestor, Pravachol, Lescol, Livalo) without problems, and would be willing to withdraw from statin for the duration of the trial (4 weeks without statin prior to randomization for washout period, then treatment with protocol medication for 10 week duration of the trial)

Exclusion Criteria:

  • Individuals with intolerance of, or allergy to red yeast rice or omega 3 fatty acids.
  • Individuals currently taking a statin (HMG-CoA Reductase inhibitor) including Lipitor, Zocor, Crestor, Pravachol, Lescol, Livalo) or other lipid metabolism altering product within four (4) weeks prior to randomization who do not wish to withdraw from therapy.
  • Individual taking prescription or over the counter medications (including dietary supplements) known to alter lipid metabolism within four (4) weeks of randomization. Medications excluded within 4 weeks of randomization are: prescription omega-3 fatty acids, statins, bile acid sequestrants, cholesterol absorption inhibitors, niacin or fibrates. Dietary supplements excluded within 4 weeks prior to randomization are: L-carnitine, policosanol, guggulipid, sterol/stanol products, red rice yeast supplements, garlic supplements, soy isoflavone supplements, niacin or its analogues, probiotics and dietary fiber supplements (including >2 teaspoons Metamucil or psyllium-containing supplements per day and prebiotics), or any dietary supplement or vitamin complex product containing omega 3 acids or fish oil.
  • Use of systemic corticosteroids, androgens (except androgens for hypogonadism to restore normal levels), phenytoin, erythromycin and other macrolides, and thyroid hormones (except stable-dose thyroid replacement therapy for four (4) weeks prior to enrollment).
  • Use of the anticoagulants warfarin (Coumadin) or dabigatran (Pradaxa), apixaban (Eliquis) or rivaroxaban (Xarelto).
  • Pregnant or lactating women, or women of childbearing potential who are not complying with an approved method of contraception. A woman is considered to be of childbearing potential unless she is post-hysterectomy, one or more years postmenopausal, or one or more years post-tubal ligation.
  • Individuals with a history of myopathy, defined as a creatine phosphokinase (CPK) >450 U/L and/or unexplained muscle pain on statins.
  • Type I or type II diabetes mellitus or HbA1c ≥7.0%
  • History of significant cardiovascular or coronary heart disease (CVD or CHD) as defined by having had a coronary artery bypass procedure, coronary stent or angioplasty, or myocardial infarction.
  • Current or recent (within six months) history of significant gastrointestinal, renal, pulmonary, hepatic or biliary disease
  • History of cancer, other than non-melanoma skin cancer and basal cell carcinoma, within the previous five years.
  • Poorly controlled or uncontrolled hypertension (systolic blood pressure ≥160 mm Hg and/or diastolic blood pressure ≥95 mm Hg).
  • Recent history (within past 6 months) of excessive alcohol use, defined as >14 drinks per week (One drink = 12 oz. beer, 4 oz. wine, 1.5 oz. hard liquor).
  • Exposure to any investigational agent within 4 weeks prior to Visit 1.
  • Has a condition the Investigator believes would interfere with the evaluation of the subject, or may put the subject at undue risk during the course of the study.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Placebo Comparator

    Arm Label

    Pro-Omega LDL

    Placebo

    Arm Description

    3 capsules 1000 mg BID for 8 weeks

    3 capsules BID for 8 weeks

    Outcomes

    Primary Outcome Measures

    Low-density lipoprotein cholesterol (LDL-C)
    Triglycerides (TG)

    Secondary Outcome Measures

    Total cholesterol
    High-density lipoprotein cholesterol (HDL-C)
    non-HDL-C
    LDL-C/HDL-C ratio
    C-reactive protein
    Adverse events
    Offset effect
    Offset effect of Pro-Omega LDL two weeks after withdrawal of placebo and Pro-Omega LDL on serum markers

    Full Information

    First Posted
    February 20, 2014
    Last Updated
    December 10, 2015
    Sponsor
    Nordic Pharma, USA
    Collaborators
    Nutrasource Pharmaceutical and Nutraceutical Services, Inc.
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02069106
    Brief Title
    Efficacy Study of Daily Pro-Omega LDL for Low-Density Lipoprotein Cholesterol and Triglyceride Reduction
    Acronym
    PrOteCT
    Official Title
    An 8-Week, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate Daily Pro-Omega LDL for Low-Density Lipoprotein Cholesterol and Triglyceride Reduction in Subjects With Mixed Hyperlipoproteinemia
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    December 2015
    Overall Recruitment Status
    Withdrawn
    Study Start Date
    February 2014 (undefined)
    Primary Completion Date
    May 2014 (Anticipated)
    Study Completion Date
    July 2014 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Nordic Pharma, USA
    Collaborators
    Nutrasource Pharmaceutical and Nutraceutical Services, Inc.

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    Pro-Omega LDL reduces low-density lipoprotein cholesterol and triglycerides in subjects with mixed hyperlipoproteinemia.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Mixed Hyperlipoproteinemia
    Keywords
    low density lipoprotein cholesterol, triglycerides, mixed hyperlipoproteinemia, Dehydroascorbic Acid, Eicosapentaenoic Acid, Fish oil

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 4
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Pro-Omega LDL
    Arm Type
    Experimental
    Arm Description
    3 capsules 1000 mg BID for 8 weeks
    Arm Title
    Placebo
    Arm Type
    Placebo Comparator
    Arm Description
    3 capsules BID for 8 weeks
    Intervention Type
    Dietary Supplement
    Intervention Name(s)
    Pro-Omega LDL
    Intervention Type
    Other
    Intervention Name(s)
    Placebo
    Primary Outcome Measure Information:
    Title
    Low-density lipoprotein cholesterol (LDL-C)
    Time Frame
    8 weeks
    Title
    Triglycerides (TG)
    Time Frame
    8 weeks
    Secondary Outcome Measure Information:
    Title
    Total cholesterol
    Time Frame
    8 weeks
    Title
    High-density lipoprotein cholesterol (HDL-C)
    Time Frame
    8 weeks
    Title
    non-HDL-C
    Time Frame
    8 weeks
    Title
    LDL-C/HDL-C ratio
    Time Frame
    8 weeks
    Title
    C-reactive protein
    Time Frame
    8 weeks
    Title
    Adverse events
    Time Frame
    4 and 8 weeks
    Title
    Offset effect
    Description
    Offset effect of Pro-Omega LDL two weeks after withdrawal of placebo and Pro-Omega LDL on serum markers
    Time Frame
    2 weeks after withdrawal

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Men or women, ≥18 years of age. History (>3months) of LDL-C ≥130 mg/dl to ≤190 mg/dL Triglycerides (TG) > 200 to <750 mg/dL Able to understand and cooperate with study procedures, and have signed a written informed consent prior to any study procedures. Willing to maintain a stable diet and level of activity throughout the trial. Willing to maintain current activity level and diet throughout the trial. If, of childbearing age, must be on a medically approved form of birth control as identified by the investigator in this trial History (> 3 months) of taking a statin medication (HMG-CoA reductase inhibitor, including Lipitor, Zocor, Crestor, Pravachol, Lescol, Livalo) without problems, and would be willing to withdraw from statin for the duration of the trial (4 weeks without statin prior to randomization for washout period, then treatment with protocol medication for 10 week duration of the trial) Exclusion Criteria: Individuals with intolerance of, or allergy to red yeast rice or omega 3 fatty acids. Individuals currently taking a statin (HMG-CoA Reductase inhibitor) including Lipitor, Zocor, Crestor, Pravachol, Lescol, Livalo) or other lipid metabolism altering product within four (4) weeks prior to randomization who do not wish to withdraw from therapy. Individual taking prescription or over the counter medications (including dietary supplements) known to alter lipid metabolism within four (4) weeks of randomization. Medications excluded within 4 weeks of randomization are: prescription omega-3 fatty acids, statins, bile acid sequestrants, cholesterol absorption inhibitors, niacin or fibrates. Dietary supplements excluded within 4 weeks prior to randomization are: L-carnitine, policosanol, guggulipid, sterol/stanol products, red rice yeast supplements, garlic supplements, soy isoflavone supplements, niacin or its analogues, probiotics and dietary fiber supplements (including >2 teaspoons Metamucil or psyllium-containing supplements per day and prebiotics), or any dietary supplement or vitamin complex product containing omega 3 acids or fish oil. Use of systemic corticosteroids, androgens (except androgens for hypogonadism to restore normal levels), phenytoin, erythromycin and other macrolides, and thyroid hormones (except stable-dose thyroid replacement therapy for four (4) weeks prior to enrollment). Use of the anticoagulants warfarin (Coumadin) or dabigatran (Pradaxa), apixaban (Eliquis) or rivaroxaban (Xarelto). Pregnant or lactating women, or women of childbearing potential who are not complying with an approved method of contraception. A woman is considered to be of childbearing potential unless she is post-hysterectomy, one or more years postmenopausal, or one or more years post-tubal ligation. Individuals with a history of myopathy, defined as a creatine phosphokinase (CPK) >450 U/L and/or unexplained muscle pain on statins. Type I or type II diabetes mellitus or HbA1c ≥7.0% History of significant cardiovascular or coronary heart disease (CVD or CHD) as defined by having had a coronary artery bypass procedure, coronary stent or angioplasty, or myocardial infarction. Current or recent (within six months) history of significant gastrointestinal, renal, pulmonary, hepatic or biliary disease History of cancer, other than non-melanoma skin cancer and basal cell carcinoma, within the previous five years. Poorly controlled or uncontrolled hypertension (systolic blood pressure ≥160 mm Hg and/or diastolic blood pressure ≥95 mm Hg). Recent history (within past 6 months) of excessive alcohol use, defined as >14 drinks per week (One drink = 12 oz. beer, 4 oz. wine, 1.5 oz. hard liquor). Exposure to any investigational agent within 4 weeks prior to Visit 1. Has a condition the Investigator believes would interfere with the evaluation of the subject, or may put the subject at undue risk during the course of the study.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    David Becker, MD
    Organizational Affiliation
    Chestnut Hill Temple Cardiology
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

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    Efficacy Study of Daily Pro-Omega LDL for Low-Density Lipoprotein Cholesterol and Triglyceride Reduction

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