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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.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Plant sterol esters | Active Comparator | plant sterols esterified to fish oil fatty acids |
|
| placebo | Placebo Comparator | Corn oil |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Plant sterols esters | Dietary Supplement | 1.6g phytosterols and 1.3g omega-3 fatty acids per day |
|
| Measure | Description | Time Frame |
|---|---|---|
| LDL Cholesterol | Average of blood test results at -10 and 0 days (before and after run-in period) | at baseline |
| LDL-C | Blood test results following 12 weeks of intervention | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Triglycerides | Average of blood test results at -10 and 0 weeks (before and after run-in period) | at baseline |
| Triglycerides | Blood test results following 12 weeks of intervention |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Dror Harats, M.D. | Sheba Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sheba medical center | Tel Litwinsky | 52621 | Israel |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20617456 | Derived | 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. doi: 10.1007/s10557-010-6249-5. |
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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.
Recruitment period:r May 2007-Jan 2008 (8 months) Medical center
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| ID | Title | Description |
|---|---|---|
| FG000 | PS-FO | plant sterols esterified to fish oil fatty acids |
| FG001 | Control | Corn oil |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | PS-FO | plant sterols esterified to fish oil fatty acids |
| BG001 | Control | Corn oil |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | LDL Cholesterol | Average of blood test results at -10 and 0 days (before and after run-in period) | 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 | Posted | Mean | Standard Deviation | mg/dl | at baseline |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | PS-FO | plant sterols esterified to fish oil fatty acids |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| abdominal discomfort | Gastrointestinal disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Prof. Dror Harats | The Institute for Lipid and Atherosclerosis Research and Internal Medicine C, Sheba Medical Center, Tel Hashomer | 972-3-5302940 | dror@vbl.co.il |
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| ID | Term |
|---|---|
| D050171 | Dyslipidemias |
| D006937 | Hypercholesterolemia |
| D015228 | Hypertriglyceridemia |
| ID | Term |
|---|---|
| D052439 | Lipid Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D006949 | Hyperlipidemias |
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| placebo | Dietary Supplement | 4 gr of corn oil |
|
| 12 weeks |
| Total Cholesterol | Average of blood test results at -10 and 0 weeks (before and after run-in period) | at baseline |
| Total Cholesterol | Blood test results following 12 weeks of intervention | 12 weeks |
| HDL Cholesterol | Average of blood test results at -10 and 0 weeks (before and after run-in period) | at baseline |
| HDL-cholestrol | Blood test results following 12 weeks of intervention | 12 weeks |
| CRP | Blood test results on day 0 of High sensitivity C Reactive Protein | at baseline |
| CRP | Blood test results following 12 weeks of intervention of High sensetivity C reactive protein | 12 weeks |
| Apolipoprotein B100 | Blood test results on day 0 | at baseline |
| Apolipoprotein B100 | Blood test results follwing 12 weeks of intervention | 12 weeks |
| Apolipoprotein A | Blood test on day 0 | at baseline |
| Apolipoprotein A | Blood test results following 12 weeks of intervention | 12 weeks |
| BG002 |
| Total |
Total of all reporting groups |
| Participants |
|
| Age Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Secondary | Triglycerides | Average of blood test results at -10 and 0 weeks (before and after run-in period) | 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 | Posted | Mean | Standard Deviation | mg/dl | at baseline |
|
|
|
| Secondary | Triglycerides | Blood test results following 12 weeks of intervention | 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 | Posted | Mean | Standard Deviation | mg/dl | 12 weeks |
|
|
|
| Secondary | Total Cholesterol | Average of blood test results at -10 and 0 weeks (before and after run-in period) | 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 | Posted | Mean | Standard Deviation | mg/dl | at baseline |
|
|
|
| Secondary | Total Cholesterol | Blood test results following 12 weeks of intervention | 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 | Posted | Mean | Standard Deviation | mg/dl | 12 weeks |
|
|
|
| Secondary | HDL Cholesterol | Average of blood test results at -10 and 0 weeks (before and after run-in period) | 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 | Posted | Mean | Standard Deviation | mg/dl | at baseline |
|
|
|
| Primary | LDL-C | Blood test results following 12 weeks of intervention | 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 | Posted | Mean | Standard Deviation | md/dl | 12 weeks |
|
|
|
| Secondary | HDL-cholestrol | Blood test results following 12 weeks of intervention | 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 | Posted | Mean | Standard Deviation | mg/dl | 12 weeks |
|
|
|
| Secondary | CRP | Blood test results on day 0 of High sensitivity C Reactive Protein | 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 | Posted | Mean | Standard Deviation | mg/l | at baseline |
|
|
|
| Secondary | CRP | Blood test results following 12 weeks of intervention of High sensetivity C reactive protein | 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 | Posted | Mean | Standard Deviation | mg/l | 12 weeks |
|
|
|
| Secondary | Apolipoprotein B100 | Blood test results on day 0 | 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 | Posted | Mean | Standard Deviation | mg/dl | at baseline |
|
|
|
| Secondary | Apolipoprotein B100 | Blood test results follwing 12 weeks of intervention | 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 | Posted | Mean | Standard Deviation | mg/dl | 12 weeks |
|
|
|
| Secondary | Apolipoprotein A | Blood test on day 0 | 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 | Posted | Mean | Standard Deviation | mg/dl | at baseline |
|
|
|
| Secondary | Apolipoprotein A | Blood test results following 12 weeks of intervention | 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 | Posted | Mean | Standard Deviation | mg/dl | 12 weeks |
|
|
|
| 0 |
| 46 |
| 1 |
| 46 |
| EG001 | Control | Corn oil | 0 | 45 | 1 | 45 |
| Itching rash | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
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