Comparative Study Menaquinone-7

NCT ID: NCT01873274

Last Updated: 2013-06-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

107 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-04-30

Study Completion Date

2013-05-31

Brief Summary

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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

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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.

Conditions

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Bioavailability

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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basic yogurt enriched with MK-7

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

Group Type ACTIVE_COMPARATOR

basic yogurt enriched with MK-7

Intervention Type DIETARY_SUPPLEMENT

MK-7 containing capsule

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

Group Type ACTIVE_COMPARATOR

MK-7 containing capsule

Intervention Type DIETARY_SUPPLEMENT

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)

Group Type ACTIVE_COMPARATOR

nutrient-enriched yogurt with MK-7

Intervention Type DIETARY_SUPPLEMENT

Interventions

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MK-7 containing capsule

Intervention Type DIETARY_SUPPLEMENT

basic yogurt enriched with MK-7

Intervention Type DIETARY_SUPPLEMENT

nutrient-enriched yogurt with MK-7

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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
Minimum Eligible Age

45 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Maastricht University Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Cees Vermeer, PhD

Role: PRINCIPAL_INVESTIGATOR

VitaK BV Maastricht University

Locations

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VitaK BV / Maastricht University Medical Center

Maastricht, , Netherlands

Site Status

Countries

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Netherlands

Other Identifiers

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12-3-009

Identifier Type: -

Identifier Source: org_study_id

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