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

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ClinicalTrials.gov Identifier: NCT00441480
Recruitment Status : Completed
First Posted : March 1, 2007
Results First Posted : August 14, 2009
Last Update Posted : January 13, 2012
Information provided by:

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Dyslipidemia
Interventions: Dietary Supplement: Plant sterols esters
Dietary Supplement: placebo

  Participant Flow

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
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 
Protocol Violation                1                1 
Withdrawal by Subject                2                3 

  Baseline Characteristics

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.
No text entered.

Reporting Groups
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 
Overall Participants Analyzed 
[Units: Participants]
 46   45   91 
[Units: Participants]
<=18 years   0   0   0 
Between 18 and 65 years   41   43   84 
>=65 years   5   2   7 
[Units: Years]
Mean (Standard Deviation)
 51  (10.8)   49.4  (9.3)   50.2  (10.1) 
[Units: Participants]
Female   9   11   20 
Male   37   34   71 
Region of Enrollment 
[Units: Participants]
Israel   46   45   91 

  Outcome Measures

1.  Primary:   LDL Cholesterol   [ Time Frame: at baseline ]

2.  Primary:   LDL-C   [ Time Frame: 12 weeks ]

3.  Secondary:   Triglycerides   [ Time Frame: at baseline ]

4.  Secondary:   Triglycerides   [ Time Frame: 12 weeks ]

5.  Secondary:   Total Cholesterol   [ Time Frame: at baseline ]

6.  Secondary:   Total Cholesterol   [ Time Frame: 12 weeks ]

7.  Secondary:   HDL Cholesterol   [ Time Frame: at baseline ]

8.  Secondary:   HDL-cholestrol   [ Time Frame: 12 weeks ]

9.  Secondary:   CRP   [ Time Frame: at baseline ]

10.  Secondary:   CRP   [ Time Frame: 12 weeks ]

11.  Secondary:   Apolipoprotein B100   [ Time Frame: at baseline ]

12.  Secondary:   Apolipoprotein B100   [ Time Frame: 12 weeks ]

13.  Secondary:   Apolipoprotein A   [ Time Frame: at baseline ]

14.  Secondary:   Apolipoprotein A   [ Time Frame: 12 weeks ]

  Serious Adverse Events

  Other Adverse Events

  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.

  More Information

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.

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

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
First Submitted: February 28, 2007
First Posted: March 1, 2007
Results First Submitted: July 1, 2009
Results First Posted: August 14, 2009
Last Update Posted: January 13, 2012