Comparative Study Menaquinone-7

Study Overview
=================
Brief Summary
-----------------
The objective of this study is to investigate the absorption of menaquinone-7 from a nutrient-enriched dairy product compared to a general dairy product enriched with menaquinone-7 and a menaquinone-7-containing supplement.

Detailed Description
-----------------
In an earlier study, beneficial effects of a nutrient-enriched dairy product on vitamin K-status were observed. The study product contained menaquinone-7 (MK-7) and omega-3 fatty acids for vascular health and extra minerals and antioxidants to support general health. It was the first time that such low dose of MK-7 (50 µg) could significantly improve vascular and general vitamin K-status already after short-term treatment. From the results of this study, it was assumed that the matrix of the dairy product and/or other components in the product, in which the vitamin was offered, contributed to optimal absorption and availability of vitamin K2. In this new study, the uptake and efficacy of MK-7 from the nutrient enriched product is investigated and compared to the uptake and efficacy from a MK-7-containing supplement and a basic dairy product enriched with MK-7.

Official Title
-----------------
Comparative Study of Three Delivery Systems of Menaquinone-7

Conditions
-----------------
Bioavailability

Intervention / Treatment
-----------------
* Dietary Supplement: MK-7 containing capsule
* Dietary Supplement: basic yogurt enriched with MK-7
* Dietary Supplement: nutrient-enriched yogurt with MK-7


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Apparently healthy men and postmenopausal women between 45 and 65 years old Subjects with body weight and height according to BMI between 20 and 30 kg/m2 Subjects of Caucasian race Subject has given written consent to take part in the study Exclusion Criteria: Subjects with hypertension Subjects with hypercholesterolemia Subjects with (a history of) metabolic or gastrointestinal disease Subjects presenting chronic degenerative and/or inflammatory disease Subjects with (a history) of diabetes mellitus Abuse of drugs and/or alcohol Subjects receiving corticosteroid treatment Subjects using oral anticoagulants and subjects with clotting disorders Subjects using blood pressure-lowering medication Subjects using cholesterol-lowering medication Subjects using multivitamins or vitamin K supplements Subjects consuming high amounts of vitamin K-containing food products Subjects with cow's milk allergy and lactose intolerance

Ages Eligible for Study
-----------------
Minimum Age: 45 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: basic yogurt enriched with MK-7<br>one study group will receive daily two basic dairy products enriched with MK-7 (50 μg) | Dietary Supplement: basic yogurt enriched with MK-7<br> <br> |
| Active Comparator: MK-7 containing capsule<br>one study group will receive daily a softgel capsule consisting of 50 μg MK-7 | Dietary Supplement: MK-7 containing capsule<br> <br> |
| Active Comparator: nutrient enriched yogurt with MK-7<br>one study group will receive daily two nutrient-enriched dairy products containing extra nutrients and omega-3 FA (fish-oil) | Dietary Supplement: nutrient-enriched yogurt with MK-7<br> <br> |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The change in plasma MK-7 concentration after intervention between the three study groups |  | baseline and 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The change in circulating markers of vitamin K-status, undercarboxylated osteocalcin and desphospho-uncarboxylated matrix Gla-protein, after intervention between the three study groups. |  | baseline and 6 weeks |