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Completed

NCT Number: NCT01873274

Comparative Study Menaquinone-7

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.

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Key information

Conditions

Age range

45 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

VitaK BV / Maastricht University Medical Center

Maastricht, 6229 EV, Netherlands

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

MK-7 containing capsule

Dietary Supplement

basic yogurt enriched with MK-7

Dietary Supplement

nutrient-enriched yogurt with MK-7

Dietary Supplement

Primary outcomes

  1. The change in plasma MK-7 concentration after intervention between the three study groups

    Time frame: baseline and 6 weeks

Secondary outcomes

  1. The change in circulating markers of vitamin K-status, undercarboxylated osteocalcin and desphospho-uncarboxylated matrix Gla-protein, after intervention between the three study groups.

    Time frame: baseline and 6 weeks

Other outcomes

  1. The change in circulating vitamin D (25-hydroxy-vitamin D) after intervention between the study groups.

    Time frame: baseline and 6 weeks

Sponsors and collaborators

Lead sponsor

Maastricht University Medical Center

Other

Registry information

Official study title

Comparative Study of Three Delivery Systems of Menaquinone-7

Important dates

Study start
2012
Primary completion
2012
Study completion
2013
First posted
Jun 10, 2013
Registry last updated
Jun 13, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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