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
  Purpose

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.


Condition Intervention Phase
Dyslipidemia
Dietary Supplement: Plant sterols esters
Dietary Supplement: 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: Effect of Plant Sterols Esterified to Fish Oil Fatty Acids on Plasma Lipid Levels in Healthy, Hyperlipidemic Subjects

Resource links provided by NLM:


Further study details as provided by Enzymotec:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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


Enrollment: 91
Study Start Date: March 2007
Study Completion Date: June 2008
Primary Completion Date: June 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Plant sterol esters
plant sterols esterified to fish oil fatty acids
Dietary Supplement: Plant sterols esters
1.6g phytosterols and 1.3g omega-3 fatty acids per day
Other Name: PS-FO
Placebo Comparator: placebo
Corn oil
Dietary Supplement: placebo
4 gr of corn oil
Other Name: Placebo

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00441480

Locations
Israel
Sheba medical center
Tel-HaShomer, Israel, 52621
Sponsors and Collaborators
Enzymotec
Investigators
Principal Investigator: Dror Harats, M.D. Sheba Medical Center
  More Information

No publications provided by Enzymotec

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Yael Herzog, Enzymotec LTD
ClinicalTrials.gov Identifier: NCT00441480     History of Changes
Other Study ID Numbers: CardiaBeat_003
Study First Received: February 28, 2007
Results First Received: July 1, 2009
Last Updated: January 12, 2012
Health Authority: Israel: Ethics Commission

Keywords provided by Enzymotec:
Hypercholesterolemia
Hypertriglyceridemia
Plant sterol
Cholesterol
Fish oil

Additional relevant MeSH terms:
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases

ClinicalTrials.gov processed this record on April 15, 2014