Effect of Plant Sterols Esterified to Fish Oil Fatty Acids on Plasma Lipid Levels - Full Text View

Sponsored by:	Enzymotec
Information provided by:	Enzymotec
ClinicalTrials.gov Identifier:	NCT00441480

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 esterified to fish oil fatty acids	Phase IV

Genetics Home Reference related topics: hypercholesterolemia

MedlinePlus related topics: Cholesterol

Drug Information available for: Cholest-5-en-3-ol (3beta)- Fish oil Lipids

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study
Official Title:	Effect of Plant Sterols Esterified to Fish Oil Fatty Acids on Plasma Lipid Levels in Healthy, Hyperlipidemic Subjects

Further study details as provided by Enzymotec:

Primary Outcome Measures:

LDL cholesterol [ Time Frame: On day -10, 0, week 6 and week 12 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Triglyceride [ Time Frame: On day -10, 0, week 6 and week 12 ] [ Designated as safety issue: No ]
Total cholesterol [ Time Frame: On day -10, 0, week 6 and week 12 ] [ Designated as safety issue: No ]
HDL cholesterol [ Time Frame: On day -10, 0, week 6 and week 12 ] [ Designated as safety issue: No ]
High sensitivity C Reactive Protein [ Time Frame: On day 0, week 6 and week 12 ] [ Designated as safety issue: No ]
Oxidative stress [ Time Frame: On day 0, week 6 and week 12 ] [ Designated as safety issue: No ]
Apolipoprotein A-I [ Time Frame: On day 0, week 6 and week 12 ] [ Designated as safety issue: No ]
Apolipoprotein B100 [ Time Frame: On day 0, week 6 and week 12 ] [ Designated as safety issue: No ]
Apolipoprotein C-II and C-III [ Time Frame: On day 0, week 6 and week 12 ] [ Designated as safety issue: No ]

Estimated Enrollment:	130
Study Start Date:	March 2007
Estimated Primary Completion Date:	June 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Active Comparator plant sterols esterified to fish oil fatty acids	Dietary Supplement: Plant sterols esterified to fish oil fatty acids 1.6g phytosterols and 1.3g omega-3 fatty acids per day
2: Placebo Comparator Corn oil	Dietary Supplement: Plant sterols esterified to fish oil fatty acids 1.6g phytosterols and 1.3g omega-3 fatty acids per day

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

Contacts

Contact: Tamar Luvish

972-3-5302940

tamar.luvish@sheba.health.gov.il

Locations

Israel
Sheba medical center	Recruiting
Tel-HaShomer, Israel, 52621
Contact: Tamar Luvish 03-5302940 tamar.luvish@sheba.health.gov.il
Principal Investigator: Dror Harats, M.D.

Sponsors and Collaborators

Enzymotec

Investigators

Principal Investigator:

Dror Harats, M.D.

Sheba Medical Center

More Information

Responsible Party:	Enzymotec LTD ( Yael Herzog )
Study ID Numbers:	CardiaBeat_003
Study First Received:	February 28, 2007
Last Updated:	March 13, 2008
ClinicalTrials.gov Identifier:	NCT00441480
Health Authority:	Israel: Ethics Commission

Keywords provided by Enzymotec:

Hypercholesterolemia
Hypertriglyceridemia
Plant sterol
Cholesterol
Fish oil

Study placed in the following topic categories:

Metabolic Diseases
Hypertriglyceridemia
Healthy
Metabolic disorder

Hypercholesterolemia
Dyslipidemias
Lipid Metabolism Disorders

ClinicalTrials.gov processed this record on January 14, 2009