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
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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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
  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 ]

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
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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
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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.


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:

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