Effects of Dairy on Vitamin K-status

Study Overview
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Brief Summary
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In this study, the beneficial effect of a nutrient enriched dairy product will be investigated on vitamin K-status. To achive this benefit, the study product contains extra vitamin K2. In addition, extra dairy minerals have been added to the study product that may support general health.

Detailed Description
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In earlier studies, cardiovascular disease and osteoporosis were found to be associated with K2 intake, notably the higher menaquinones, MK-7, MK-8 and MK-9. Of these higher menaquinones, MK-7 was suggested to be the most effective form with respect to intestinal absorption, biologic half-life time, and efficacy on circulating biochemical markers. MK-7 is a natural product that is found in cheese, curd, and the Japanese food natto. Therefore, a nutrient enriched dairy product has been developed containing MK-7. The efficacy of this new product will be investigated on vitamin K status and on general health markers.

Official Title
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The Effects of a Vitamin K-enriched Dairy Product on Vitamin K-status

Conditions
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Vitamin K-status, Vascular Health

Intervention / Treatment
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* Dietary Supplement: nutrient enriched product
* Dietary Supplement: basic dairy product


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Apparently healthy men and postmenopausal women between 45 and 65 years old Subjects of body weight and height according to BMI between 23 and 30 kg/m2 Subjects of Caucasian race Subject has given written consent to take part in the study Low vitamin K-status 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 corticosteroϊd 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

Ages Eligible for Study
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Minimum Age: 45 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: nutrient enriched dairy<br>Yoghurt product which contains vitamin K2 and extra dairy nutrients; all in a concentration of 15% of the recommended allowed daily intake (RDI) | Dietary Supplement: nutrient enriched product<br>* The intervention in this study consists of the consumption of two nutrient enriched yoghurt products. The participants consume the study products twice a day during 12 weeks, one yoghurt product (250 ml) during breakfast and one yoghurt product (250 ml) during dinner.<br>|
| Placebo Comparator: Basic dairy<br>2 basic yoghurt products | Dietary Supplement: basic dairy product<br>* The intervention in this study consists of the consumption of two basic yoghurt products. The participants consume the basic yoghurt products twice a day during 12 weeks, one yoghurt product (250 ml) during breakfast and one yoghurt product (250 ml) during dinner.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| undercarboxylated and carboxylated matrix-gla protein | The purpose of this study is to investigate the nutrient enriched product on vitamin K status as determined from the carboxylation status of Matrix Gla Protein | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| undercarboxylated and carboxylated osteocalcin | The second purpose of this study is to investigate the nutrient enriched product on vitamin K status as determined from the carboxylation status of the vitamin K-dependent protein osteocalcin | 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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vitamin K2, menaquinone-7, vascular health