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

History of Changes

Results First Received: July 1, 2009

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
Condition:	Dyslipidemia
Interventions:	Dietary Supplement: Plant sterols esters Dietary Supplement: placebo

Participant Flow

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Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Recruitment period:r May 2007-Jan 2008 (8 months) Medical center

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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.

Reporting Groups

	Description
PS-FO	plant sterols esterified to fish oil fatty acids
Control	Corn oil

Participant Flow: Overall Study

	PS-FO	Control
STARTED	46	45
COMPLETED	43	41
NOT COMPLETED	3	4
Protocol Violation	1	1
Withdrawal by Subject	2	3

Baseline Characteristics

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Reporting Groups

	Description
PS-FO	plant sterols esterified to fish oil fatty acids
Control	Corn oil
Total	Total of all reporting groups

Baseline Measures

	PS-FO	Control	Total
Number of Participants [units: participants]	46	45	91
Age [units: participants]
<=18 years	0	0	0
Between 18 and 65 years	41	43	84
>=65 years	5	2	7
Age [units: years] Mean ± Standard Deviation	51 ± 10.8	49.4 ± 9.3	50.2 ± 10.1
Gender [units: participants]
Female	9	11	20
Male	37	34	71
Region of Enrollment [units: participants]
Israel	46	45	91

Outcome Measures

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1. Primary:

LDL Cholesterol [ Time Frame: at baseline ]

Measure Type	Primary
Measure Title	LDL Cholesterol
Measure Description	Average of blood test results at -10 and 0 days (before and after run-in period)
Time Frame	at baseline
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Subjects whose body weight were changed from baseline value by more than 3 kg during the interventions or had compliance below 65% were excluded from analysis before breaking the randomization code. It was done since these changes may have a significant influence on the study end points

Reporting Groups

	Description
PS-FO	plant sterols esterified to fish oil fatty acids
Control	Corn oil

Measured Values

	PS-FO	Control
Number of Participants Analyzed [units: participants]	34	33
LDL Cholesterol [units: mg/dl] Mean ± Standard Deviation	159.7 ± 17.22	157.8 ± 15.54

No statistical analysis provided for LDL Cholesterol

2. Primary:

LDL-C [ Time Frame: 12 weeks ]

Measure Type	Primary
Measure Title	LDL-C
Measure Description	Blood test results following 12 weeks of intervention
Time Frame	12 weeks
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Subjects whose body weight were changed from baseline value by more than 3 kg during the interventions or had compliance below 65% were excluded from analysis before breaking the randomization code. It was done since these changes may have a significant influence on the study end points

Reporting Groups

	Description
PS-FO	plant sterols esterified to fish oil fatty acids
Control	Corn oil

Measured Values

	PS-FO	Control
Number of Participants Analyzed [units: participants]	34	33
LDL-C [units: md/dl] Mean ± Standard Deviation	154.7 ± 21.0	155.1 ± 20.1

No statistical analysis provided for LDL-C

3. Secondary:

Triglycerides [ Time Frame: at baseline ]

Measure Type	Secondary
Measure Title	Triglycerides
Measure Description	Average of blood test results at -10 and 0 weeks (before and after run-in period)
Time Frame	at baseline
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Subjects whose body weight were changed from baseline value by more than 3 kg during the interventions or had compliance below 65% were excluded from analysis before breaking the randomization code. It was done since these changes may have a significant influence on the study end points

Reporting Groups

	Description
PS-FO	plant sterols esterified to fish oil fatty acids
Control	Corn oil

Measured Values

	PS-FO	Control
Number of Participants Analyzed [units: participants]	34	33
Triglycerides [units: mg/dl] Mean ± Standard Deviation	244.9 ± 83.2	248.9 ± 65.4

No statistical analysis provided for Triglycerides

4. Secondary:

Triglycerides [ Time Frame: 12 weeks ]

Measure Type	Secondary
Measure Title	Triglycerides
Measure Description	Blood test results following 12 weeks of intervention
Time Frame	12 weeks
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Subjects whose body weight were changed from baseline value by more than 3 kg during the interventions or had compliance below 65% were excluded from analysis before breaking the randomization code. It was done since these changes may have a significant influence on the study end points

Reporting Groups

	Description
PS-FO	plant sterols esterified to fish oil fatty acids
Control	Corn oil

Measured Values

	PS-FO	Control
Number of Participants Analyzed [units: participants]	34	33
Triglycerides [units: mg/dl] Mean ± Standard Deviation	193.9 ± 77.0	233.0 ± 95.0

No statistical analysis provided for Triglycerides

5. Secondary:

Total Cholesterol [ Time Frame: at baseline ]

Measure Type	Secondary
Measure Title	Total Cholesterol
Measure Description	Average of blood test results at -10 and 0 weeks (before and after run-in period)
Time Frame	at baseline
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Subjects whose body weight were changed from baseline value by more than 3 kg during the interventions or had compliance below 65% were excluded from analysis before breaking the randomization code. It was done since these changes may have a significant influence on the study end points

Reporting Groups

	Description
PS-FO	plant sterols esterified to fish oil fatty acids
Control	Corn oil

Measured Values

	PS-FO	Control
Number of Participants Analyzed [units: participants]	34	33
Total Cholesterol [units: mg/dl] Mean ± Standard Deviation	244.3 ± 24.7	239.6 ± 22.7

No statistical analysis provided for Total Cholesterol

6. Secondary:

Total Cholesterol [ Time Frame: 12 weeks ]

Measure Type	Secondary
Measure Title	Total Cholesterol
Measure Description	Blood test results following 12 weeks of intervention
Time Frame	12 weeks
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Subjects whose body weight were changed from baseline value by more than 3 kg during the interventions or had compliance below 65% were excluded from analysis before breaking the randomization code. It was done since these changes may have a significant influence on the study end points

Reporting Groups

	Description
PS-FO	plant sterols esterified to fish oil fatty acids
Control	Corn oil

Measured Values

	PS-FO	Control
Number of Participants Analyzed [units: participants]	34	33
Total Cholesterol [units: mg/dl] Mean ± Standard Deviation	233.8 ± 28.0	236.5 ± 27.7

No statistical analysis provided for Total Cholesterol

7. Secondary:

HDL Cholesterol [ Time Frame: at baseline ]

Measure Type	Secondary
Measure Title	HDL Cholesterol
Measure Description	Average of blood test results at -10 and 0 weeks (before and after run-in period)
Time Frame	at baseline
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Subjects whose body weight were changed from baseline value by more than 3 kg during the interventions or had compliance below 65% were excluded from analysis before breaking the randomization code. It was done since these changes may have a significant influence on the study end points

Reporting Groups

	Description
PS-FO	plant sterols esterified to fish oil fatty acids
Control	Corn oil

Measured Values

	PS-FO	Control
Number of Participants Analyzed [units: participants]	34	33
HDL Cholesterol [units: mg/dl] Mean ± Standard Deviation	46.0 ± 9.1	44.2 ± 7.7

No statistical analysis provided for HDL Cholesterol

8. Secondary:

HDL-cholestrol [ Time Frame: 12 weeks ]

Measure Type	Secondary
Measure Title	HDL-cholestrol
Measure Description	Blood test results following 12 weeks of intervention
Time Frame	12 weeks
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Subjects whose body weight were changed from baseline value by more than 3 kg during the interventions or had compliance below 65% were excluded from analysis before breaking the randomization code. It was done since these changes may have a significant influence on the study end points

Reporting Groups

	Description
PS-FO	plant sterols esterified to fish oil fatty acids
Control	Corn oil

Measured Values

	PS-FO	Control
Number of Participants Analyzed [units: participants]	34	33
HDL-cholestrol [units: mg/dl] Mean ± Standard Deviation	46.4 ± 9.8	44.7 ± 10.5

No statistical analysis provided for HDL-cholestrol

9. Secondary:

CRP [ Time Frame: at baseline ]

Measure Type	Secondary
Measure Title	CRP
Measure Description	Blood test results on day 0 of High sensitivity C Reactive Protein
Time Frame	at baseline
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Subjects whose body weight were changed from baseline value by more than 3 kg during the interventions or had compliance below 65% were excluded from analysis before breaking the randomization code. It was done since these changes may have a significant influence on the study end points

Reporting Groups

	Description
PS-FO	plant sterols esterified to fish oil fatty acids
Control	Corn oil

Measured Values

	PS-FO	Control
Number of Participants Analyzed [units: participants]	34	33
CRP [units: mg/l] Mean ± Standard Deviation	3.07 ± 3.45	3.25 ± 2.61

No statistical analysis provided for CRP

10. Secondary:

CRP [ Time Frame: 12 weeks ]

Measure Type	Secondary
Measure Title	CRP
Measure Description	Blood test results following 12 weeks of intervention of High sensetivity C reactive protein
Time Frame	12 weeks
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Subjects whose body weight were changed from baseline value by more than 3 kg during the interventions or had compliance below 65% were excluded from analysis before breaking the randomization code. It was done since these changes may have a significant influence on the study end points

Reporting Groups

	Description
PS-FO	plant sterols esterified to fish oil fatty acids
Control	Corn oil

Measured Values

	PS-FO	Control
Number of Participants Analyzed [units: participants]	34	33
CRP [units: mg/l] Mean ± Standard Deviation	2.47 ± 2.45	4.51 ± 4.15

No statistical analysis provided for CRP

11. Secondary:

Apolipoprotein B100 [ Time Frame: at baseline ]

Measure Type	Secondary
Measure Title	Apolipoprotein B100
Measure Description	Blood test results on day 0
Time Frame	at baseline
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Subjects whose body weight were changed from baseline value by more than 3 kg during the interventions or had compliance below 65% were excluded from analysis before breaking the randomization code. It was done since these changes may have a significant influence on the study end points

Reporting Groups

	Description
PS-FO	plant sterols esterified to fish oil fatty acids
Control	Corn oil

Measured Values

	PS-FO	Control
Number of Participants Analyzed [units: participants]	34	33
Apolipoprotein B100 [units: mg/dl] Mean ± Standard Deviation	130.6 ± 15.7	129.4 ± 14.3

No statistical analysis provided for Apolipoprotein B100

12. Secondary:

Apolipoprotein B100 [ Time Frame: 12 weeks ]

Measure Type	Secondary
Measure Title	Apolipoprotein B100
Measure Description	Blood test results follwing 12 weeks of intervention
Time Frame	12 weeks
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Subjects whose body weight were changed from baseline value by more than 3 kg during the interventions or had compliance below 65% were excluded from analysis before breaking the randomization code. It was done since these changes may have a significant influence on the study end points

Reporting Groups

	Description
PS-FO	plant sterols esterified to fish oil fatty acids
Control	Corn oil

Measured Values

	PS-FO	Control
Number of Participants Analyzed [units: participants]	34	33
Apolipoprotein B100 [units: mg/dl] Mean ± Standard Deviation	130.0 ± 19.1	130.3 ± 17.0

No statistical analysis provided for Apolipoprotein B100

13. Secondary:

Apolipoprotein A [ Time Frame: at baseline ]

Measure Type	Secondary
Measure Title	Apolipoprotein A
Measure Description	Blood test on day 0
Time Frame	at baseline
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Subjects whose body weight were changed from baseline value by more than 3 kg during the interventions or had compliance below 65% were excluded from analysis before breaking the randomization code. It was done since these changes may have a significant influence on the study end points

Reporting Groups

	Description
PS-FO	plant sterols esterified to fish oil fatty acids
Control	Corn oil

Measured Values

	PS-FO	Control
Number of Participants Analyzed [units: participants]	34	33
Apolipoprotein A [units: mg/dl] Mean ± Standard Deviation	126.3 ± 13.5	125.6 ± 13.6

No statistical analysis provided for Apolipoprotein A

14. Secondary:

Apolipoprotein A [ Time Frame: 12 weeks ]

Measure Type	Secondary
Measure Title	Apolipoprotein A
Measure Description	Blood test results following 12 weeks of intervention
Time Frame	12 weeks
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Subjects whose body weight were changed from baseline value by more than 3 kg during the interventions or had compliance below 65% were excluded from analysis before breaking the randomization code. It was done since these changes may have a significant influence on the study end points

Reporting Groups

	Description
PS-FO	plant sterols esterified to fish oil fatty acids
Control	Corn oil

Measured Values

	PS-FO	Control
Number of Participants Analyzed [units: participants]	34	33
Apolipoprotein A [units: mg/dl] Mean ± Standard Deviation	128.2 ± 14.5	127.8 ± 16.3

No statistical analysis provided for Apolipoprotein A

Serious Adverse Events

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Other Adverse Events

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More Information

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Certain Agreements:

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.

Results Point of Contact:

Name/Title: Prof. Dror Harats
Organization: The Institute for Lipid and Atherosclerosis Research and Internal Medicine C, Sheba Medical Center, Tel Hashomer
phone: 972-3-5302940
e-mail: dror@vbl.co.il

No publications provided by Enzymotec

Publications automatically indexed to this study:

Bitzur R, Cohen H, Cohen T, Dror TW, Herzog Y, Lifshitz Y, Lubish T, Harats D, Rubinstein A. The metabolic effects of omega-3 plant sterol esters in mixed hyperlipidemic subjects. Cardiovasc Drugs Ther. 2010 Dec;24(5-6):429-37.

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

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