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

Sponsor

Nordic Pharma, USA (Industry)

Overall Status

Withdrawn

CT.gov ID

NCT02069106

Collaborator

Nutrasource Pharmaceutical and Nutraceutical Services, Inc. (Other)

Enrollment

Arms

4.9

Duration (Months)

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Mixed Hyperlipoproteinemia	Dietary Supplement: Pro-Omega LDL Other: Placebo	Phase 4

Study Design

Study Type:

Interventional

Actual Enrollment :

0 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

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 Start Date :

Feb 1, 2014

Anticipated Primary Completion Date :

May 1, 2014

Anticipated Study Completion Date :

Jul 1, 2014

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Low-density lipoprotein cholesterol (LDL-C) [8 weeks]
Triglycerides (TG) [8 weeks]

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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.