Effects of Dairy on Vitamin K-status

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

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.

Study Overview

• Status: Completed
• Conditions: Vascular Health; Vitamin K-status
• Intervention / Treatment: Dietary supplement: nutrient enriched product; Dietary supplement: basic dairy product

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 62
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Netherlands
  • Maastricht, Netherlands, 6229 EV
    • Vitak BV / Maastricht University Medical Center

Participation Criteria

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 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: nutrient enriched dairy; 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; 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.
Placebo Comparator: Basic dairy; 2 basic yoghurt products	Dietary supplement: basic dairy product; 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.

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
markers of vascular health and inflammation	The secondary purpose of this study is to investigate the nutrient enriched product on markers of vascular and general health	12 weeks

Collaborators and Investigators

• Sponsor: Maastricht University Medical Center

Study record dates

Study Major Dates

• Study Start: September 1, 2010
• Primary Completion (Actual): December 1, 2010
• Study Completion (Actual): April 1, 2012

Study Registration Dates

• First Submitted: July 9, 2012
• First Submitted That Met QC Criteria: August 21, 2012
• First Posted (Estimate): August 24, 2012

Study Record Updates

• Last Update Posted (Estimate): August 24, 2012
• Last Update Submitted That Met QC Criteria: August 21, 2012
• Last Verified: August 1, 2012

More Information

Terms related to this study

• Keywords: menaquinone-7; vitamin K2; vascular health
• Other Study ID Numbers: 10-3-037