Effects of Dairy on Vitamin K-status

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Maastricht University Medical Center
ClinicalTrials.gov Identifier:
NCT01672099
First received: July 9, 2012
Last updated: August 21, 2012
Last verified: August 2012
  Purpose

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.


Condition Intervention
Vitamin K-status
Vascular Health
Dietary Supplement: nutrient enriched product
Dietary Supplement: basic dairy product

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: The Effects of a Vitamin K-enriched Dairy Product on Vitamin K-status

Resource links provided by NLM:


Further study details as provided by Maastricht University Medical Center:

Primary Outcome Measures:
  • undercarboxylated and carboxylated matrix-gla protein [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    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:
  • undercarboxylated and carboxylated osteocalcin [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    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 Outcome Measures:
  • markers of vascular health and inflammation [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    The secondary purpose of this study is to investigate the nutrient enriched product on markers of vascular and general health


Enrollment: 62
Study Start Date: September 2010
Study Completion Date: April 2012
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   45 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01672099

Locations
Netherlands
Vitak BV / Maastricht University Medical Center
Maastricht, Netherlands, 6229 EV
Sponsors and Collaborators
Maastricht University Medical Center
Investigators
Principal Investigator: Cees Vermeer, PhD VitaK BV Maastricht University
  More Information

No publications provided

Responsible Party: Maastricht University Medical Center
ClinicalTrials.gov Identifier: NCT01672099     History of Changes
Other Study ID Numbers: 10-3-037
Study First Received: July 9, 2012
Last Updated: August 21, 2012
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Keywords provided by Maastricht University Medical Center:
vitamin K2
menaquinone-7
vascular health

Additional relevant MeSH terms:
Vitamin K
Vitamins
Antifibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Hemostatics
Coagulants
Hematologic Agents
Therapeutic Uses
Micronutrients
Growth Substances
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on August 26, 2014