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

This study has been withdrawn prior to enrollment.
Sponsor:
Collaborator:
Nordic Naturals
Information provided by (Responsible Party):
Nutrasource Diagnostics Inc.
ClinicalTrials.gov Identifier:
NCT02069106
First received: February 20, 2014
Last updated: May 15, 2014
Last verified: May 2014
  Purpose

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


Condition Intervention Phase
Mixed Hyperlipoproteinemia
Dietary Supplement: Pro-Omega LDL
Other: Placebo
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:


Further study details as provided by Nutrasource Diagnostics Inc.:

Primary Outcome Measures:
  • Low-density lipoprotein cholesterol (LDL-C) [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
  • Triglycerides (TG) [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Total cholesterol [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
  • High-density lipoprotein cholesterol (HDL-C) [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
  • non-HDL-C [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
  • LDL-C/HDL-C ratio [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
  • C-reactive protein [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
  • Adverse events [ Time Frame: 4 and 8 weeks ] [ Designated as safety issue: Yes ]
  • Offset effect [ Time Frame: 2 weeks after withdrawal ] [ Designated as safety issue: No ]
    Offset effect of Pro-Omega LDL two weeks after withdrawal of placebo and Pro-Omega LDL on serum markers


Enrollment: 0
Study Start Date: February 2014
Estimated Study Completion Date: July 2014
Estimated Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02069106

Sponsors and Collaborators
Nutrasource Diagnostics Inc.
Nordic Naturals
Investigators
Principal Investigator: David Becker, MD Chestnut Hill Temple Cardiology
  More Information

No publications provided

Responsible Party: Nutrasource Diagnostics Inc.
ClinicalTrials.gov Identifier: NCT02069106     History of Changes
Other Study ID Numbers: 1001-PR-003-09092013
Study First Received: February 20, 2014
Last Updated: May 15, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Nutrasource Diagnostics Inc.:
low density lipoprotein cholesterol
triglycerides
mixed hyperlipoproteinemia
Dehydroascorbic Acid
Eicosapentaenoic Acid
Fish oil

Additional relevant MeSH terms:
Hyperlipidemia, Familial Combined
Hyperlipoproteinemias
Lipid Metabolism, Inborn Errors
Metabolism, Inborn Errors
Genetic Diseases, Inborn
Hyperlipidemias
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases

ClinicalTrials.gov processed this record on July 22, 2014