Effect of Plant Sterols Esterified to Fish Oil Fatty Acids on Plasma Lipid Levels

This study has been completed.
Sponsor:
Information provided by:
Enzymotec
ClinicalTrials.gov Identifier:
NCT00441480
First received: February 28, 2007
Last updated: January 12, 2012
Last verified: January 2012

February 28, 2007
January 12, 2012
March 2007
June 2008   (final data collection date for primary outcome measure)
  • LDL Cholesterol [ Time Frame: at baseline ] [ Designated as safety issue: No ]
    Average of blood test results at -10 and 0 days (before and after run-in period)
  • LDL-C [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    Blood test results following 12 weeks of intervention
Not Provided
Complete list of historical versions of study NCT00441480 on ClinicalTrials.gov Archive Site
  • Triglycerides [ Time Frame: at baseline ] [ Designated as safety issue: No ]
    Average of blood test results at -10 and 0 weeks (before and after run-in period)
  • Triglycerides [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    Blood test results following 12 weeks of intervention
  • Total Cholesterol [ Time Frame: at baseline ] [ Designated as safety issue: No ]
    Average of blood test results at -10 and 0 weeks (before and after run-in period)
  • Total Cholesterol [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    Blood test results following 12 weeks of intervention
  • HDL Cholesterol [ Time Frame: at baseline ] [ Designated as safety issue: No ]
    Average of blood test results at -10 and 0 weeks (before and after run-in period)
  • HDL-cholestrol [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    Blood test results following 12 weeks of intervention
  • CRP [ Time Frame: at baseline ] [ Designated as safety issue: No ]
    Blood test results on day 0 of High sensitivity C Reactive Protein
  • CRP [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    Blood test results following 12 weeks of intervention of High sensetivity C reactive protein
  • Apolipoprotein B100 [ Time Frame: at baseline ] [ Designated as safety issue: No ]
    Blood test results on day 0
  • Apolipoprotein B100 [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    Blood test results follwing 12 weeks of intervention
  • Apolipoprotein A [ Time Frame: at baseline ] [ Designated as safety issue: No ]
    Blood test on day 0
  • Apolipoprotein A [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    Blood test results following 12 weeks of intervention
Not Provided
Not Provided
Not Provided
 
Effect of Plant Sterols Esterified to Fish Oil Fatty Acids on Plasma Lipid Levels
Effect of Plant Sterols Esterified to Fish Oil Fatty Acids on Plasma Lipid Levels in Healthy, Hyperlipidemic Subjects

The purpose of this study is to determine whether plant sterols esterified to fish oil fatty acids in a fish oil matrix improve the lipid profile, predominantly LDL-cholesterol and TG concentrations in healthy hyperlipidemic subjects.

Phytosterols and omega-3 fatty acids (n-3) are natural food ingredients with potential cardiovascular (CVD) benefits. Phytosterols inhibit dietary cholesterol absorption and biliary cholesterol re-absorption, thereby reducing blood cholesterol levels, while consumption of n-3 is associated with a significant reduction in plasma triglyceride concentrations. Furthermore, n-3 may also beneficially modify a number of other risk factors of CHD, like anti-inflammatory and anti-thrombotic.

The primary objective of this study is to determine whether plant sterols esterified to fish oil fatty acids in a fish oil matrix improve the lipid profile, predominantly LDL-cholesterol and TG concentrations in healthy hyperlipidemic subjects. In addition the supplement efficacy to lower other CVD-related risk factors of healthy will be evaluated.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Dyslipidemia
  • Dietary Supplement: Plant sterols esters
    1.6g phytosterols and 1.3g omega-3 fatty acids per day
    Other Name: PS-FO
  • Dietary Supplement: placebo
    4 gr of corn oil
    Other Name: Placebo
  • Active Comparator: Plant sterol esters
    plant sterols esterified to fish oil fatty acids
    Intervention: Dietary Supplement: Plant sterols esters
  • Placebo Comparator: placebo
    Corn oil
    Intervention: Dietary Supplement: placebo
Bitzur R, Cohen H, Cohen T, Dror TW, Herzog Y, Lifshitz Y, Lubish T, Harats D, Rubinstein A. The metabolic effects of omega-3 plant sterol esters in mixed hyperlipidemic subjects. Cardiovasc Drugs Ther. 2010 Dec;24(5-6):429-37.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
91
June 2008
June 2008   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Male or female, >18 years old and ≤ 70 years old, capable and willing to give written informed consent.
  • Subject must have hyperlipidemia at the screening visit and at the end of the run-in period, defined as: fasting plasma triglycerides > 150 mg/dl and < 500 mg/dl, LDL-cholesterol > 130 mg/dl and < 190 mg/dl.
  • Fasting plasma glucose (FPG) levels at the screening visit < 110 mg/dl.
  • Female patient who is of reproductive potential agree to use acceptable methods of birth control
  • Female patient who is currently receiving hormone replacement therapy continuously 12 weeks before visit 1 (on stable dose) and will agree to do so during the study.

Exclusion Criteria:

  • Receiving medications or supplements known to affect lipid metabolism.
  • Uncontrolled hypertension or thyroid disease.
  • Consume unusual diets - will be determined at the discretion of the investigator.
  • Gained or lost more than 3 kg during the run-in period.
  • Patient has history of malignancy ≤ 5 years.
  • Patients with clinical ischemic CV disease on treatment
  • Consume 200 grams fish x 2 a week.
  • Gastrointestinal disease or any disease that the investigator feels would compromise the patient safety or limit his/her successful participation to the study.
  • Patient has type 1 or type 2 diabetes mellitus.
  • Patient has uncontrolled endocrine or metabolic disease known to influence serum lipids or lipoproteins
  • Patient has had active peptic ulcer disease within 3 months of visit 1.
  • Woman patient is pregnant or breast-feeding or expecting to conceive during the study.
  • Patient has a history of hypersensitivity or allergy to fish, fish oil, corn oil or soy.
Both
18 Years to 70 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Israel
 
NCT00441480
CardiaBeat_003
Yes
Yael Herzog, Enzymotec LTD
Enzymotec
Not Provided
Principal Investigator: Dror Harats, M.D. Sheba Medical Center
Enzymotec
January 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP