Vitamin K-absorption From Dairy
Absorption of Different Forms of Vitamin K From Dairy Products
1 other identifier
interventional
12
1 country
1
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
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable healthy
Started Apr 2009
1 active site
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
CompletedFirst Submitted
Initial submission to the registry
June 30, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2009
CompletedFirst Posted
Study publicly available on registry
July 2, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2009
CompletedDecember 16, 2010
December 1, 2010
3 months
June 30, 2009
December 15, 2010
Conditions
Keywords
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
EXPERIMENTALone single intake of a dairy product containing several K-vitamins: phylloquinone, menaquinone-7,8,9-and 10.
Interventions
several forms of vitamin K: phylloquinone, menaquinone-7,-8,-9,and -10.
Eligibility Criteria
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
Study Officials
- PRINCIPAL INVESTIGATOR
Cees Vermeer, PhD
VitaK / University of Maastricht
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