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| Name | Class |
|---|---|
| Kappa Bioscience AS | UNKNOWN |
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The aim of the study is to obtain insight into a dose-dependent effect of vitamin K2 on oxidative stress and specific markers of the immune system.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | matched dose of sunflower oil |
|
| Vitamin K2 low dose | Experimental | 333 μg/d Vitamin K2 (MK-7) |
|
| Vitamin K2 high dose | Experimental | 666 μg/d Vitamin K2 (MK-7) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vitamin K2 | Dietary Supplement | (K2VITAL® 1% MCT Oil) |
|
| Measure | Description | Time Frame |
|---|---|---|
| plasma ox-LDL | Dose dependent change in ox-LDL levels | 3 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| plasma MDA | Dose dependent change in plasma MDA levels | 3 weeks |
| plasma CRP | Dose dependent change in plasma CRP levels | 3 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| NIZO food research | Ede | Netherlands |
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| ID | Term |
|---|---|
| D007249 | Inflammation |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D024482 | Vitamin K 2 |
| ID | Term |
|---|---|
| D014812 | Vitamin K |
| D009285 | Naphthoquinones |
| D009281 | Naphthalenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
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3 way crossover trial for evaluating the effect on oxidative stress markers. The first study period, is also used as a parallel study for studying the effect on immune markers.
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| Placebo | Dietary Supplement | Sunflower oil |
|
| IL-6 | Dose dependent change in plasma IL-6 levels | 3 weeks |
| Phagocytosis capacity | % positive and MFI of monocytes and granulocytes | 3 weeks |
| PBMC gene expression | Differential Gene Expression analysis (DGE) - Fold change and relative abundance | 3 weeks |
| D006841 |
| Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D010836 | Phytol |
| D004224 | Diterpenes |
| D013729 | Terpenes |
| D011809 | Quinones |
| D011083 | Polycyclic Compounds |