Clinical trial NCT01873274: Comparative Study Menaquinone-7
Official title: Comparative Study of Three Delivery Systems of Menaquinone-7
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Bioavailability
Lead sponsor: Maastricht University Medical Center
Sponsor class: OTHER
First posted: 2013-06-10
Enrollment: 107
Sex: ALL
Minimum age (years): 45
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: The change in plasma MK-7 concentration after intervention between the three study groups
timeFrame: baseline and 6 weeks
Secondary outcomes:
measure: The change in circulating markers of vitamin K-status, undercarboxylated osteocalcin and desphospho-uncarboxylated matrix Gla-protein, after intervention between the three study groups.
timeFrame: baseline and 6 weeks
Other outcomes:
measure: The change in circulating vitamin D (25-hydroxy-vitamin D) after intervention between the study groups.
timeFrame: baseline and 6 weeks
Locations:
city: Maastricht
country: Netherlands
facility: VitaK BV / Maastricht University Medical Center
Study officials:
affiliation: VitaK BV Maastricht University
name: Cees Vermeer, PhD
role: PRINCIPAL_INVESTIGATOR
References: