Comparison of Absorption of Vitamin K2

Study Overview
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Brief Summary
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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.

Official Title
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Comparison of Absorption of Vitamin K2 Human Study Gelpell

Conditions
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Healthy

Intervention / Treatment
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* Dietary Supplement: Vitamin K2 in softgel
* Dietary Supplement: Vitamin K2 in Gelpell


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy men and women between 20 and 30 years old Subjects of normal body weight and height according to BMI < 30 Subjects of Caucasian race Subject has given written consent to take part in the study Exclusion Criteria: Subjects with (a history of) metabolic or gastrointestinal disease Subjects presenting chronic degenerative and/or inflammatory disease Subjects receiving corticoϊd treatment Subjects using oral anticoagulants Subject with (a history of) soy allergy Subjects using vitamin K containing multivitamins or vitamin K supplements Subjects with anaemia or subjects who recently donate blood.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 30 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>softgel capsules | Dietary Supplement: Vitamin K2 in softgel<br>* 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<br>|
| Active Comparator: 2<br>Gelpell capsules | Dietary Supplement: Vitamin K2 in Gelpell<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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absorption, encapsulation, menaquinone, Bio-availability