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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
History of Changes

June 30, 2009
December 15, 2010
April 2009
July 2009   (final data collection date for primary outcome measure)
serum vitamin K levels: phylloquinone, menaquinone-7,-8,-9,and -10 [ Time Frame: one single intake ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00931437 on ClinicalTrials.gov Archive Site
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 ]
Same as current
Not Provided
Not Provided
 
Vitamin K-absorption From Dairy
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.
Not Provided
Interventional
Not Provided
Endpoint Classification: Bio-availability Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Healthy
Dietary Supplement: vitamin K-rich dairy product
several forms of vitamin K: phylloquinone, menaquinone-7,-8,-9,and -10.
Experimental: vitamin K-rich dairy product
one single intake of a dairy product containing several K-vitamins: phylloquinone, menaquinone-7,8,9-and 10.
Intervention: Dietary Supplement: vitamin K-rich dairy product
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
12
November 2009
July 2009   (final data collection date for primary outcome measure)

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
Both
20 Years to 45 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Netherlands
 
NCT00931437
08-3-086
No
Dr. C. Vermeer, VitaK BV
Maastricht University Medical Center
Not Provided
Principal Investigator: Cees Vermeer, PhD VitaK / University of Maastricht
Maastricht University Medical Center
December 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP