Comparative study of three delivery systems of menaquinone-7

Completed

Conditions: preventie van hart-en vaatziekten
vitamin K deficiency
vitamin K insufficiency

Registration Number: NL-OMON37333

Lead Sponsor: niversiteit Maastricht

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 114

Inclusion Criteria

Apparently healthy men and postmenopausal women between 45 and 65 years old
Subjects with body weight and height according to BMI between 23 and 30 kg/m2
Subject has given written consent to take part in the study
Subjects of Caucasian race

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

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The circulating MK-7 levels will be measured at the various time-points (t = 0,<br /><br>2, 4, 6 weeks) during intervention and the wash-out period (t= 3 days, 1 and 2<br /><br>weeks) to determine the absorption profile of MK-7 within the dairy product. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>The biochemical markers carboxylated MGP (cMGP), desphospho-uncarboxylated MGP<br /><br>(dp-ucMGP), carboxylated osteocalcin (cOC) and uncarboxylated osteocalcin<br /><br>(ucOC), will be measured at the various time-points (t = 0, 4, 6, 7 and 8<br /><br>weeks) to determine the efficacy of the nutrient-enriched product vs. the other<br /><br>2 products on MGP carboxylation status in the vessel wall and OC carboxylation. </p><br>