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| Name | Class |
|---|---|
| VitaK | UNKNOWN |
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From previous studies it appeared that menaquinone-7 (MK-7) is the most effective form of vitamin K. The Japanese soya product natto is one of the richest food sources of MK-7. However, the taste of natto is not appreciated by the western society. For this reason the active biological compound is produced as a capsule. Different techniques of encapsulation the vitamin can lead to different absorption profiles with intake. Therefore it is important to study influence of type of encapsulation technique on absorption of menaquinone-7.
This study is undertaken to compare absorption of menaquinones between two different encapsulation techniques. Absorption profiles of menaquinone-4 and menaquinone-7 of conventional softgel capsules and newly developed GellpelTM capsules are compared between each other.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Active Comparator | softgel capsules |
|
| 2 | Active Comparator | Gelpell capsules |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vitamin K2 in softgel | Dietary Supplement | 4 softgel capsules containing 45 µg MK-7 and 5 µg vitamin D3 per capsule and 4 softgel capsules containing 30 µg MK-4 per capsule |
|
| Measure | Description | Time Frame |
|---|---|---|
| The mean difference in plasma concentration of MK-4 and MK-7 between the two types of capsules (softgel or gelpell)concerns the primary outcome measure. | 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| The mean difference in serum concentration of vitamin D3 between the two types of capsules (softgel or gelpell) concerns the secondary endpoint for this study. | 4 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Cees Vermeer, PhD | Maastricht University, VitaK BV | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| VitaK BV / Maastricht University | Maastricht | 6200 MD | Netherlands |
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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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| Vitamin K2 in Gelpell | Dietary Supplement | 4 Gelpell capsules containing 45 µg MK-7 and 5 µg vitamin D3 per capsule and 4 Gelpell capsules containing 30 µg MK-4 per capsule |
|
| D006841 |
| Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D010836 | Phytol |
| D004224 | Diterpenes |
| D013729 | Terpenes |
| D011809 | Quinones |
| D011083 | Polycyclic Compounds |