Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Comparative Study Menaquinone-7

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01873274
Recruitment Status : Completed
First Posted : June 10, 2013
Last Update Posted : June 13, 2013
Sponsor:
Information provided by (Responsible Party):
Maastricht University Medical Center

Brief Summary:
The objective of this study is to investigate the absorption of menaquinone-7 from a nutrient-enriched dairy product compared to a general dairy product enriched with menaquinone-7 and a menaquinone-7-containing supplement.

Condition or disease Intervention/treatment Phase
Bioavailability Dietary Supplement: MK-7 containing capsule Dietary Supplement: basic yogurt enriched with MK-7 Dietary Supplement: nutrient-enriched yogurt with MK-7 Not Applicable

Detailed Description:
In an earlier study, beneficial effects of a nutrient-enriched dairy product on vitamin K-status were observed. The study product contained menaquinone-7 (MK-7) and omega-3 fatty acids for vascular health and extra minerals and antioxidants to support general health. It was the first time that such low dose of MK-7 (50 µg) could significantly improve vascular and general vitamin K-status already after short-term treatment. From the results of this study, it was assumed that the matrix of the dairy product and/or other components in the product, in which the vitamin was offered, contributed to optimal absorption and availability of vitamin K2. In this new study, the uptake and efficacy of MK-7 from the nutrient enriched product is investigated and compared to the uptake and efficacy from a MK-7-containing supplement and a basic dairy product enriched with MK-7.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 107 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Comparative Study of Three Delivery Systems of Menaquinone-7
Study Start Date : April 2012
Actual Primary Completion Date : October 2012
Actual Study Completion Date : May 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Vitamin K

Arm Intervention/treatment
Active Comparator: basic yogurt enriched with MK-7
one study group will receive daily two basic dairy products enriched with MK-7 (50 μg)
Dietary Supplement: basic yogurt enriched with MK-7
Active Comparator: MK-7 containing capsule
one study group will receive daily a softgel capsule consisting of 50 μg MK-7
Dietary Supplement: MK-7 containing capsule
Active Comparator: nutrient enriched yogurt with MK-7
one study group will receive daily two nutrient-enriched dairy products containing extra nutrients and omega-3 FA (fish-oil)
Dietary Supplement: nutrient-enriched yogurt with MK-7



Primary Outcome Measures :
  1. The change in plasma MK-7 concentration after intervention between the three study groups [ Time Frame: baseline and 6 weeks ]

Secondary Outcome Measures :
  1. The change in circulating markers of vitamin K-status, undercarboxylated osteocalcin and desphospho-uncarboxylated matrix Gla-protein, after intervention between the three study groups. [ Time Frame: baseline and 6 weeks ]

Other Outcome Measures:
  1. The change in circulating vitamin D (25-hydroxy-vitamin D) after intervention between the study groups. [ Time Frame: baseline and 6 weeks ]


Information from the National Library of Medicine

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, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   45 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Apparently healthy men and postmenopausal women between 45 and 65 years old
  • Subjects with body weight and height according to BMI between 20 and 30 kg/m2
  • Subjects of Caucasian race
  • Subject has given written consent to take part in the study

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 corticosteroid 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01873274


Locations
Layout table for location information
Netherlands
VitaK BV / Maastricht University Medical Center
Maastricht, Netherlands, 6229 EV
Sponsors and Collaborators
Maastricht University Medical Center
Investigators
Layout table for investigator information
Principal Investigator: Cees Vermeer, PhD VitaK BV Maastricht University

Layout table for additonal information
Responsible Party: Maastricht University Medical Center
ClinicalTrials.gov Identifier: NCT01873274     History of Changes
Other Study ID Numbers: 12-3-009
First Posted: June 10, 2013    Key Record Dates
Last Update Posted: June 13, 2013
Last Verified: June 2013

Additional relevant MeSH terms:
Layout table for MeSH terms
Vitamin K 2
Vitamin K
Vitamin MK 7
Nutrients
Growth Substances
Physiological Effects of Drugs
Antifibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Hemostatics
Coagulants
Vitamins
Micronutrients