Comparative Study Menaquinone-7

Maastricht University Medical Centre (MUMC)

Status: Completed

Conditions: Bioavailability

Treatments: Dietary Supplement: basic yogurt enriched with MK-7; Dietary Supplement: MK-7 containing capsule; Dietary Supplement: nutrient-enriched yogurt with MK-7

Study type: Interventional

Funder types: Other

Identifiers

NCT01873274

12-3-009

Details and patient eligibility

About

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.

Full 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.

Enrollment: 107 patients

Sex: All

Ages: 45 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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107 participants in 3 patient groups

basic yogurt enriched with MK-7

Active Comparator group

Description:

one study group will receive daily two basic dairy products enriched with MK-7 (50 μg)

Treatment:

Dietary Supplement: basic yogurt enriched with MK-7

MK-7 containing capsule

Active Comparator group

Description:

one study group will receive daily a softgel capsule consisting of 50 μg MK-7

Treatment:

Dietary Supplement: MK-7 containing capsule

nutrient enriched yogurt with MK-7

Active Comparator group

Description:

one study group will receive daily two nutrient-enriched dairy products containing extra nutrients and omega-3 FA (fish-oil)

Treatment:

Dietary Supplement: nutrient-enriched yogurt with MK-7