Comparative Study Menaquinone-7

Comparative Study of Three Delivery Systems of 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.

Study Overview

• Status: Completed
• Conditions: Bioavailability
• Intervention / Treatment: Dietary supplement: basic yogurt enriched with MK-7; Dietary supplement: MK-7 containing capsule; Dietary supplement: nutrient-enriched yogurt with MK-7

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.

• Study Type: Interventional
• Enrollment (Actual): 107
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Netherlands
  • Maastricht, Netherlands, 6229 EV
    • Vitak BV / Maastricht University Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 45 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: basic yogurt enriched with MK-7; one study group will receive daily two basic dairy products enriched with MK-7 (50 μg)	Dietary supplement: basic yogurt enriched with MK-7
Active Comparator: MK-7 containing capsule; one study group will receive daily a softgel capsule consisting of 50 μg MK-7	Dietary supplement: MK-7 containing capsule
Active Comparator: nutrient enriched yogurt with MK-7; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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	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

Other Outcome Measures

Outcome Measure	Time Frame
The change in circulating vitamin D (25-hydroxy-vitamin D) after intervention between the study groups.	baseline and 6 weeks

Collaborators and Investigators

• Sponsor: Maastricht University Medical Center

Study record dates

Study Major Dates

• Study Start: April 1, 2012
• Primary Completion (Actual): October 1, 2012
• Study Completion (Actual): May 1, 2013

Study Registration Dates

• First Submitted: May 30, 2013
• First Submitted That Met QC Criteria: June 5, 2013
• First Posted (Estimate): June 10, 2013

Study Record Updates

• Last Update Posted (Estimate): June 13, 2013
• Last Update Submitted That Met QC Criteria: June 12, 2013
• Last Verified: June 1, 2013

More Information

Terms related to this study

• Other Study ID Numbers: 12-3-009