Effects of Dairy on Vitamin K-status

Not Applicable

Completed

• Conditions: Vitamin K-status; Vascular Health
• Interventions: Dietary Supplement: nutrient enriched product; Dietary Supplement: basic dairy product

• Registration Number: NCT01672099
• Lead Sponsor: Maastricht University Medical Center

Brief Summary

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

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 Timeline

• Study Start: 2010-09
• Primary Completion: 2010-12
• Study Completion: 2012-04
• Study First Submitted: 2012-07-09
• Status Verified: 2012-08
• Study First Submitted QC: 2012-08-21
• Last Update Submitted: 2012-08-21
• Study First Posted: 2012-08-24
• Last Update Posted: 2012-08-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 62

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
nutrient enriched dairy	nutrient enriched product	Yoghurt product which contains vitamin K2 and extra dairy nutrients; all in a concentration of 15% of the recommended allowed daily intake (RDI)
Basic dairy	basic dairy product	2 basic yoghurt products

Primary Outcome Measures

Name	Time	Method
undercarboxylated and carboxylated matrix-gla protein	12 weeks	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

Secondary Outcome Measures

Name	Time	Method
undercarboxylated and carboxylated osteocalcin	12 weeks	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

Trial Locations

Locations (1)

Vitak BV / Maastricht University Medical Center; 🇳🇱 Maastricht, Netherlands