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
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: 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 September 29, 2014