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| Name | Class |
|---|---|
| Clinical Research Institute HUCH Ltd | OTHER |
Purpose of the study is to determine the effect of the investigational products as consumed with a meal on serum lipids, primarily on LDL cholesterol.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Supplement product with plant stanol ester | Experimental |
| |
| Placebo supplement product | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Supplement product with plant stanol ester | Dietary Supplement | 2 grams plant stanols consumed with a meal daily for 3 to 4 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Proportional change in serum LDL cholesterol | Proportional change [end of intervention - start of intervention] in serum LDL-cholesterol between intervention and control groups in subjects fulfilling the inclusion criteria at the beginning of the study. | 3 to 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Proportional change in total cholesterol | Proportional change [end of intervention - start of intervention] in serum total cholesterol between intervention and control groups in subjects fulfilling the inclusion criteria at the beginning of the study. | 3 to 4 weeks |
| Proportional change in non-HDL-cholesterol |
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Inclusion Criteria:
Exclusion Criteria:
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| ID | Term |
|---|---|
| D006937 | Hypercholesterolemia |
| D006949 | Hyperlipidemias |
| D050171 | Dyslipidemias |
| ID | Term |
|---|---|
| D052439 | Lipid Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| C407042 | plant stanol ester |
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Proportional change [end of intervention - start of intervention] in serum non-HDL-cholesterol between intervention and control groups in subjects fulfilling the inclusion criteria at the beginning of the study. |
| 3 to 4 weeks |
| Proportional change in serum triglycerides | Proportional change [end of intervention - start of intervention] in serum triglycerides between intervention and control groups in subjects fulfilling the inclusion criteria at the beginning of the study. | 3 to 4 weeks |
| Proportional change in lipids in all study participants | Proportional change [end of intervention - start of intervention] in serum lipids in all study participants (ITT analysis) | 3 to 4 weeks |
| Proportional change in lipids in subjects without metabolic derangements | Proportional change [end of intervention - start of intervention] in serum lipids in study participants without metabolic derangements (excluding those with type two diabetes and/or metabolic syndrome) | 3 to 4 weeks |