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

Conditions

Dyslipidemia

Keywords

Hypercholesterolemia, Hypertriglyceridemia, Plant sterol, Cholesterol, Fish oil

Brief 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.

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.

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Interventions

DIETARY_SUPPLEMENTPlant sterols esters

1.6g phytosterols and 1.3g omega-3 fatty acids per day

DIETARY_SUPPLEMENTplacebo

4 gr of corn oil

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 70 Years

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame	Description
LDL Cholesterol	at baseline	Average of blood test results at -10 and 0 days (before and after run-in period)
LDL-C	12 weeks	Blood test results following 12 weeks of intervention

Secondary

Measure	Time frame	Description
HDL Cholesterol	at baseline	Average of blood test results at -10 and 0 weeks (before and after run-in period)
HDL-cholestrol	12 weeks	Blood test results following 12 weeks of intervention
Triglycerides	at baseline	Average of blood test results at -10 and 0 weeks (before and after run-in period)
Apolipoprotein B100	at baseline	Blood test results on day 0
Apolipoprotein A	at baseline	Blood test on day 0
CRP	at baseline	Blood test results on day 0 of High sensitivity C Reactive Protein
Total Cholesterol	at baseline	Average of blood test results at -10 and 0 weeks (before and after run-in period)

Countries

Israel

Participant flow

Recruitment details

Recruitment period:r May 2007-Jan 2008 (8 months) Medical center

Pre-assignment details

10 -14 days run-in phase during which they received placebo capsules. Run-in phase enabled to exclude subjects who had an unstable weight (gained or lost more than 3 kg) during this period or who didn't meet entry criteria of LDL-c and TG at screening visit and at baseline visit.

Participants by arm

Arm	Count
PS-FO plant sterols esterified to fish oil fatty acids	46
Control Corn oil	45
Total	91

Withdrawals & dropouts

Period	Reason	FG000	FG001
Overall Study	Protocol Violation	1	1
Overall Study	Withdrawal by Subject	2	3

Baseline characteristics

Characteristic	Control	PS-FO	Total
Age, Categorical <=18 years	0 Participants	0 Participants	0 Participants
Age, Categorical >=65 years	2 Participants	5 Participants	7 Participants
Age, Categorical Between 18 and 65 years	43 Participants	41 Participants	84 Participants
Age Continuous	49.4 years STANDARD_DEVIATION 9.3	51 years STANDARD_DEVIATION 10.8	50.2 years STANDARD_DEVIATION 10.1
Region of Enrollment Israel	45 participants	46 participants	91 participants
Sex: Female, Male Female	11 Participants	9 Participants	20 Participants
Sex: Female, Male Male	34 Participants	37 Participants	71 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk
deaths Total, all-cause mortality	— / —	— / —
other Total, other adverse events	1 / 46	1 / 45
serious Total, serious adverse events	0 / 46	0 / 45

Outcome results

Primary