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Comparative Study Menaquinone-7

Comparative Study of Three Delivery Systems of Menaquinone-7

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01873274
Enrollment
107
Registered
2013-06-10
Start date
2012-04-30
Completion date
2013-05-31
Last updated
2013-06-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bioavailability

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.

Interventions

DIETARY_SUPPLEMENTMK-7 containing capsule
DIETARY_SUPPLEMENTbasic yogurt enriched with MK-7
DIETARY_SUPPLEMENTnutrient-enriched yogurt with MK-7

Sponsors

Maastricht University Medical Center
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
45 Years to 65 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frame
The change in plasma MK-7 concentration after intervention between the three study groupsbaseline and 6 weeks

Secondary

MeasureTime 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

Other

MeasureTime frame
The change in circulating vitamin D (25-hydroxy-vitamin D) after intervention between the study groups.baseline and 6 weeks

Countries

Netherlands

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026