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The study is a randomised, double-blind, placebocontrolled, parallel dose-response study with four study arms. Sixty subjects will be randomly allocated to consume study products containing varying amounts of plant sterol (PS) oxidation products (POP) or placebo for 6 weeks.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | 0 mg/d added POP |
|
| low dosage | Active Comparator | low added POP |
|
| Medium dose | Active Comparator | medium added POP |
|
| Hige dose | Active Comparator | high added POP |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| cookies enriched with POP | Other | Cookies |
|
| Measure | Description | Time Frame |
|---|---|---|
| POP (plant sterol oxidation products) value | To estimate the change from baseline in serum POP concentration after intake of various POP doses. | 0 to 42 days |
| Measure | Description | Time Frame |
|---|---|---|
| COP (cholesterol oxidation products) value | To estimate the change from baseline in serum COP concentrations after intake of various POP doses. | 0 to 42 days |
| Ratio of serum POP concentration | To estimate the ratio of serum POP concentrations vs. COP concentrations after intake of various POP doses. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Christian Keicher, Dr | Charité Research Organisation GmbH | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Charité Research Organisation GmbH | Berlin | 10117 | Germany |
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| 0 to 42 days |