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

Dyslipidemia Clinical Trial

Official title:

Effect of Plant Sterols Esterified to Fish Oil Fatty Acids on Plasma Lipid Levels in Healthy, Hyperlipidemic Subjects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00441480
• Other study ID #: CardiaBeat_003
• Status: Completed
• Phase: Phase 4
• First received: February 28, 2007
• Last updated: January 12, 2012
• Start date: March 2007
• Est. completion date: June 2008

Study information

• Verified date: January 2012
• Source: Enzymotec
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Ethics Commission
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 91
• Est. completion date: June 2008
• Est. primary completion date: June 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Dyslipidemia
• Dyslipidemias

Intervention

Dietary Supplement:
• Plant sterols esters
1.6g phytosterols and 1.3g omega-3 fatty acids per day
• placebo
4 gr of corn oil

Locations

Country	Name	City	State
Israel	Sheba medical center	Tel-HaShomer

Sponsors (1)

Lead Sponsor	Collaborator
Enzymotec

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	LDL Cholesterol	Average of blood test results at -10 and 0 days (before and after run-in period)	at baseline	No
Primary	LDL-C	Blood test results following 12 weeks of intervention	12 weeks	No
Secondary	Triglycerides	Average of blood test results at -10 and 0 weeks (before and after run-in period)	at baseline	No
Secondary	Triglycerides	Blood test results following 12 weeks of intervention	12 weeks	No
Secondary	Total Cholesterol	Average of blood test results at -10 and 0 weeks (before and after run-in period)	at baseline	No
Secondary	Total Cholesterol	Blood test results following 12 weeks of intervention	12 weeks	No
Secondary	HDL Cholesterol	Average of blood test results at -10 and 0 weeks (before and after run-in period)	at baseline	No
Secondary	HDL-cholestrol	Blood test results following 12 weeks of intervention	12 weeks	No
Secondary	CRP	Blood test results on day 0 of High sensitivity C Reactive Protein	at baseline	No
Secondary	CRP	Blood test results following 12 weeks of intervention of High sensetivity C reactive protein	12 weeks	No
Secondary	Apolipoprotein B100	Blood test results on day 0	at baseline	No
Secondary	Apolipoprotein B100	Blood test results follwing 12 weeks of intervention	12 weeks	No
Secondary	Apolipoprotein A	Blood test on day 0	at baseline	No
Secondary	Apolipoprotein A	Blood test results following 12 weeks of intervention	12 weeks	No