Vitamin K-absorption From Dairy

December 15, 2010 updated by: Maastricht University Medical Center

Absorption of Different Forms of Vitamin K From Dairy Products

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

12

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Netherlands
      • Maastricht, Netherlands
        • VitaK BV / University of Maastricht

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 45 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
serum vitamin K levels: phylloquinone, menaquinone-7,-8,-9,and -10
Time Frame: one single intake
one single intake

Secondary Outcome Measures

Outcome Measure
Time Frame
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
one single intake

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Maastricht University Medical Center

Investigators

  • Principal Investigator: Cees Vermeer, PhD, VitaK / University of Maastricht

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2009

Primary Completion (Actual)

July 1, 2009

Study Completion (Actual)

November 1, 2009

Study Registration Dates

First Submitted

June 30, 2009

First Submitted That Met QC Criteria

June 30, 2009

First Posted (Estimate)

July 2, 2009

Study Record Updates

Last Update Posted (Estimate)

December 16, 2010

Last Update Submitted That Met QC Criteria

December 15, 2010

Last Verified

December 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 08-3-086

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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