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Withdrawn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
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
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
NCT ID
NCT02069106
First Posted
February 20, 2014
Last Updated
December 10, 2015
Sponsor
Nordic Pharma, USA
Collaborators
Nutrasource Pharmaceutical and Nutraceutical Services, Inc.
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
Learn more about this trial
Efficacy Study of Daily Pro-Omega LDL for Low-Density Lipoprotein Cholesterol and Triglyceride Reduction
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