Comparative Study Menaquinone-7

Bioavailability Clinical Trial

Official title:

Comparative Study of Three Delivery Systems of Menaquinone-7

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01873274
• Other study ID #: 12-3-009
• Status: Completed
• Phase: N/A
• First received: May 30, 2013
• Last updated: June 12, 2013
• Start date: April 2012
• Est. completion date: May 2013

Study information

• Verified date: June 2013
• 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

The objective of this study is to investigate the absorption of menaquinone-7 from a nutrient-enriched dairy product compared to a general dairy product enriched with menaquinone-7 and a menaquinone-7-containing supplement.

Description:

In an earlier study, beneficial effects of a nutrient-enriched dairy product on vitamin K-status were observed. The study product contained menaquinone-7 (MK-7) and omega-3 fatty acids for vascular health and extra minerals and antioxidants to support general health. It was the first time that such low dose of MK-7 (50 µg) could significantly improve vascular and general vitamin K-status already after short-term treatment. From the results of this study, it was assumed that the matrix of the dairy product and/or other components in the product, in which the vitamin was offered, contributed to optimal absorption and availability of vitamin K2. In this new study, the uptake and efficacy of MK-7 from the nutrient enriched product is investigated and compared to the uptake and efficacy from a MK-7-containing supplement and a basic dairy product enriched with MK-7.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 107
• Est. completion date: May 2013
• Est. primary completion date: October 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 45 Years to 65 Years

Eligibility

Inclusion Criteria:

• Apparently healthy men and postmenopausal women between 45 and 65 years old

• Subjects with body weight and height according to BMI between 20 and 30 kg/m2

• Subjects of Caucasian race

• Subject has given written consent to take part in the study

Exclusion Criteria:

• Subjects with hypertension

• Subjects with hypercholesterolemia

• Subjects with (a history of) metabolic or gastrointestinal disease

• Subjects presenting chronic degenerative and/or inflammatory disease

• Subjects with (a history) of diabetes mellitus

• Abuse of drugs and/or alcohol

• Subjects receiving corticosteroid treatment

• Subjects using oral anticoagulants and subjects with clotting disorders

• Subjects using blood pressure-lowering medication

• Subjects using cholesterol-lowering medication

• Subjects using multivitamins or vitamin K supplements

• Subjects consuming high amounts of vitamin K-containing food products

• Subjects with cow's milk allergy and lactose intolerance

Study Design

Allocation: Randomized, Endpoint Classification: Bio-availability Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Bioavailability

Intervention

Dietary Supplement:
• MK-7 containing capsule

• basic yogurt enriched with MK-7

• nutrient-enriched yogurt with MK-7

Locations

Country	Name	City	State
Netherlands	VitaK BV / Maastricht University Medical Center	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
Other	The change in circulating vitamin D (25-hydroxy-vitamin D) after intervention between the study groups.		baseline and 6 weeks	No
Primary	The change in plasma MK-7 concentration after intervention between the three study groups		baseline and 6 weeks	No
Secondary	The change in circulating markers of vitamin K-status, undercarboxylated osteocalcin and desphospho-uncarboxylated matrix Gla-protein, after intervention between the three study groups.		baseline and 6 weeks	No