Vitamin K-absorption From Dairy

Healthy Clinical Trial

Official title:

Absorption of Different Forms of Vitamin K From Dairy Products

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00931437
• Other study ID #: 08-3-086
• Status: Completed
• Phase: N/A
• First received: June 30, 2009
• Last updated: December 15, 2010
• Start date: April 2009
• Est. completion date: November 2009

Study information

• Verified date: December 2010
• Source: Maastricht University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: November 2009
• Est. primary completion date: July 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 20 Years to 45 Years

Eligibility

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 Design

Endpoint Classification: Bio-availability Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Healthy

Intervention

Dietary Supplement:
• vitamin K-rich dairy product
several forms of vitamin K: phylloquinone, menaquinone-7,-8,-9,and -10.

Locations

Country	Name	City	State
Netherlands	VitaK BV / University of Maastricht	Maastricht

Sponsors (1)

Lead Sponsor	Collaborator
Maastricht University Medical Center

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	serum vitamin K levels: phylloquinone, menaquinone-7,-8,-9,and -10		one single intake	No
Secondary	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	No