Skip to main content
OpenTrials
Completed

NCT Number: NCT01672099

Effects of Dairy 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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

45 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Vitak BV / Maastricht University Medical Center

Maastricht, 6229 EV, Netherlands

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

nutrient enriched product

Dietary 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 product

Dietary 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.

Primary outcomes

  1. undercarboxylated and carboxylated matrix-gla protein

    Time frame: 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 outcomes

  1. undercarboxylated and carboxylated osteocalcin

    Time frame: 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

Other outcomes

  1. markers of vascular health and inflammation

    Time frame: 12 weeks

    The secondary purpose of this study is to investigate the nutrient enriched product on markers of vascular and general health

Sponsors and collaborators

Lead sponsor

Maastricht University Medical Center

Other

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2010
Study completion
2012
First posted
Aug 24, 2012
Registry last updated
Aug 24, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.