Comparative Study Menaquinone-7

Not Applicable

Completed

• Conditions: Bioavailability
• Interventions: Dietary Supplement: basic yogurt enriched with MK-7; Dietary Supplement: MK-7 containing capsule; Dietary Supplement: nutrient-enriched yogurt with MK-7

• Registration Number: NCT01873274
• Lead Sponsor: Maastricht University Medical Center

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.

Study Timeline

• Study Start: 2012-04
• Primary Completion: 2012-10
• Study Completion: 2013-05
• Study First Submitted: 2013-05-30
• Status Verified: 2013-06
• Study First Submitted QC: 2013-06-05
• Study First Posted: 2013-06-10
• Last Update Submitted: 2013-06-12
• Last Update Posted: 2013-06-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 107

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
basic yogurt enriched with MK-7	basic yogurt enriched with MK-7	one study group will receive daily two basic dairy products enriched with MK-7 (50 μg)
MK-7 containing capsule	MK-7 containing capsule	one study group will receive daily a softgel capsule consisting of 50 μg MK-7
nutrient enriched yogurt with MK-7	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)

Primary Outcome Measures

Name	Time	Method
The change in plasma MK-7 concentration after intervention between the three study groups	baseline and 6 weeks

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

VitaK BV / Maastricht University Medical Center; 🇳🇱 Maastricht, Netherlands