Vitamin K-absorption From Dairy

This study has been completed.
Sponsor:
Information provided by:
Maastricht University Medical Center
ClinicalTrials.gov Identifier:
NCT00931437
First received: June 30, 2009
Last updated: December 15, 2010
Last verified: December 2010
  Purpose

Lactic acid bacteria produce a mixture of higher menaquinones, including menaquinone-9 (MK-9) and menaquinone-10 (MK-10). Vitamin K1 (phylloquinone) is normally present in chloroplasts in green vegetables. A new dairy product is developed containing both vitamin K1 and K2-vitamins. However, the extent to which the various forms of vitamin K are absorbed from such a mixture is not known. In this study the absorption profile of phylloquinone and menaquinones from this new dairy product containing several K-vitamins is investigated. This study describes a dietary intervention experiment for one single cocktail containing several K-vitamins as part of a dairy product.


Condition Intervention
Healthy
Dietary Supplement: vitamin K-rich dairy product

Study Type: Interventional
Study Design: Endpoint Classification: Bio-availability Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Absorption of Different Forms of Vitamin K From Dairy Products

Resource links provided by NLM:


Further study details as provided by Maastricht University Medical Center:

Primary Outcome Measures:
  • serum vitamin K levels: phylloquinone, menaquinone-7,-8,-9,and -10 [ Time Frame: one single intake ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • distribution of vitamin K-forms over lipoprotein fractions: triglyceride rich lipoprotein (TGRLP), intermediate-density lipoprotein (IDL), low-density lipoprotein (LDL), high density lipoprotein (HDL) as well as the lipoprotein-free fraction (LPF) [ Time Frame: one single intake ] [ Designated as safety issue: No ]

Enrollment: 12
Study Start Date: April 2009
Study Completion Date: November 2009
Primary Completion Date: July 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: vitamin K-rich dairy product
one single intake of a dairy product containing several K-vitamins: phylloquinone, menaquinone-7,8,9-and 10.
Dietary Supplement: vitamin K-rich dairy product
several forms of vitamin K: phylloquinone, menaquinone-7,-8,-9,and -10.

  Eligibility

Ages Eligible for Study:   20 Years to 45 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy men and women between 20 and 45 years old
  • Subjects of normal body weight and height according to BMI < 30
  • Subjects of Caucasian race
  • Subject has given written consent to take part in the study

Exclusion Criteria:

  • Subjects with (a history of) metabolic or gastrointestinal disease
  • Subjects presenting chronic degenerative and/or inflammatory disease
  • Abuse of drugs and/or alcohol
  • Subjects receiving corticoid treatment
  • Subjects using oral anticoagulants
  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: NCT00931437

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

No publications provided

Responsible Party: Dr. C. Vermeer, VitaK BV
ClinicalTrials.gov Identifier: NCT00931437     History of Changes
Other Study ID Numbers: 08-3-086
Study First Received: June 30, 2009
Last Updated: December 15, 2010
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Keywords provided by Maastricht University Medical Center:
vitamin K
Bio-availability

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 28, 2014