Effects of Dairy on Vitamin K-status - Full Text View

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:

MedlinePlus related topics: Vitamin K

Drug Information available for: Menadione

U.S. FDA Resources

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

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
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Antifibrinolytic Agents

Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Hemostatics
Coagulants
Hematologic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on June 17, 2013