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

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

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

Study Overview

• Status: Withdrawn
• Conditions: Mixed Hyperlipoproteinemia
• Intervention / Treatment: Other: Placebo; Dietary supplement: Pro-Omega LDL

• Study Type: Interventional
• Phase: Phase 4

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Pro-Omega LDL; 3 capsules 1000 mg BID for 8 weeks	Dietary supplement: Pro-Omega LDL
Placebo Comparator: Placebo; 3 capsules BID for 8 weeks	Other: Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Low-density lipoprotein cholesterol (LDL-C)	8 weeks
Triglycerides (TG)	8 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
C-reactive protein		8 weeks
Total cholesterol		8 weeks
High-density lipoprotein cholesterol (HDL-C)		8 weeks
non-HDL-C		8 weeks
LDL-C/HDL-C ratio		8 weeks
Adverse events		4 and 8 weeks
Offset effect	Offset effect of Pro-Omega LDL two weeks after withdrawal of placebo and Pro-Omega LDL on serum markers	2 weeks after withdrawal

Collaborators and Investigators

• Sponsor: Nordic Pharma, USA
• Collaborators: Nutrasource Pharmaceutical and Nutraceutical Services, Inc.
• Investigators: Principal Investigator: David Becker, MD, Chestnut Hill Temple Cardiology

Study record dates

Study Major Dates

• Study Start: February 1, 2014
• Primary Completion (Anticipated): May 1, 2014
• Study Completion (Anticipated): July 1, 2014

Study Registration Dates

• First Submitted: February 20, 2014
• First Submitted That Met QC Criteria: February 20, 2014
• First Posted (Estimate): February 21, 2014

Study Record Updates

• Last Update Posted (Estimate): December 14, 2015
• Last Update Submitted That Met QC Criteria: December 10, 2015
• Last Verified: December 1, 2015

More Information

Terms related to this study

• Keywords: Fish oil; triglycerides; low density lipoprotein cholesterol; mixed hyperlipoproteinemia; Dehydroascorbic Acid; Eicosapentaenoic Acid
• Additional Relevant MeSH Terms: Metabolic Diseases; Genetic Diseases, Inborn; Metabolism, Inborn Errors; Lipid Metabolism Disorders; Dyslipidemias; Lipid Metabolism, Inborn Errors; Hypertriglyceridemia; Hyperlipidemias; Hyperlipoproteinemias; Hyperlipidemia, Familial Combined; Lipidoses; Hyperlipoproteinemia Type V
• Other Study ID Numbers: 1001-PR-003-09092013