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The aim is to determine the effect of investigational products on serum LDL cholesterol.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Plant stanol ester comparator | Active Comparator | Product that contains plant stanol ester |
|
| Placebo comparator | Placebo Comparator | Placebo product |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Product that contains plant stanol ester | Other | Product with active ingredient |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in LDL cholesterol concentration (%) | Mean relative change in serum LDL cholesterol concentration during the intervention | 0 vs 3 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| LDL cholesterol concentration | Mean absolute change in serum LDL cholesterol concentration during the intervention between test and control group | 0 vs 3 weeks |
| total cholesterol concentration |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Helena Gylling, MD | Helsinki University Hospital, Helsinki, Finland | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nightingale Health plc | Helsinki | 00330 | Finland |
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| ID | Term |
|---|---|
| D006937 | Hypercholesterolemia |
| ID | Term |
|---|---|
| D006949 | Hyperlipidemias |
| D050171 | Dyslipidemias |
| D052439 | Lipid Metabolism Disorders |
| D008659 | Metabolic Diseases |
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| Placebo product | Other | Product without active ingredient |
|
Changes in serum total cholesterol concentration during the intervention
| 0 vs 3 weeks |
| HDL cholesterol concentration | Changes in serum HDL cholesterol concentration during the intervention | 0 vs 3 weeks |
| non-HDL cholesterol concentration | Changes in serum non-HDL cholesterol concentration during the intervention | 0 vs 3 weeks |
| Total triglyceride concentration | Changes in serum triglycerides concentrations | 0 vs 3 weeks |
| NMR blood biomarkers | Changes in specific NMR blood biomarkers | 0 vs 3 weeks |
| D009750 |
| Nutritional and Metabolic Diseases |