Comparative Study Menaquinone-7
June 12, 2013 updated by: Maastricht University Medical Center
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
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
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Maastricht, Netherlands, 6229 EV
- Vitak BV / Maastricht University Medical Center
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
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
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Active Comparator: basic yogurt enriched with MK-7
one study group will receive daily two basic dairy products enriched with MK-7 (50 μg)
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Active Comparator: MK-7 containing capsule
one study group will receive daily a softgel capsule consisting of 50 μg MK-7
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|
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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)
|
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
Time Frame: baseline and 6 weeks
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baseline and 6 weeks
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
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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
|
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.
Time Frame: baseline and 6 weeks
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baseline and 6 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
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
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.