NCT00931437

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for not_applicable healthy

Timeline
Completed

Started Apr 2009

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2009

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

June 30, 2009

Completed
1 day until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 2, 2009

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2009

Completed
Last Updated

December 16, 2010

Status Verified

December 1, 2010

Enrollment Period

3 months

First QC Date

June 30, 2009

Last Update Submit

December 15, 2010

Conditions

Keywords

vitamin KBio-availability

Outcome Measures

Primary Outcomes (1)

  • serum vitamin K levels: phylloquinone, menaquinone-7,-8,-9,and -10

    one single intake

Secondary Outcomes (1)

  • 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)

    one single intake

Study Arms (1)

vitamin K-rich dairy product

EXPERIMENTAL

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

Interventions

several forms of vitamin K: phylloquinone, menaquinone-7,-8,-9,and -10.

vitamin K-rich dairy product

Eligibility Criteria

Age20 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

VitaK BV / University of Maastricht

Maastricht, Netherlands

Location

Study Officials

  • Cees Vermeer, PhD

    VitaK / University of Maastricht

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

June 30, 2009

First Posted

July 2, 2009

Study Start

April 1, 2009

Primary Completion

July 1, 2009

Study Completion

November 1, 2009

Last Updated

December 16, 2010

Record last verified: 2010-12

Locations