Effects of Dairy on Vitamin K-status

N/ACompletedNCT01672099

Maastricht University Medical Center62 enrolled

Overview

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.

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Vitamin K-status Vascular Health

Interventions

nutrient enriched productDIETARY_SUPPLEMENT

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.

basic dairy productDIETARY_SUPPLEMENT

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.

Eligibility

Sex: ALLMin age: 45 YearsMax age: 65 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Vitak BV / Maastricht University Medical Center

Maastricht, Netherlands

Outcomes

Primary Outcomes

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

Time frame: 12 weeks

Secondary Outcomes

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

Time frame: 12 weeks

Data from ClinicalTrials.gov

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