Comparison of Absorption of Vitamin K2

Not Applicable

Completed

• Conditions: Healthy
• Interventions: Dietary Supplement: Vitamin K2 in Gelpell; Dietary Supplement: Vitamin K2 in softgel

• Registration Number: NCT00742768
• Lead Sponsor: Maastricht University Medical Center

Brief Summary

From previous studies it appeared that menaquinone-7 (MK-7) is the most effective form of vitamin K. The Japanese soya product natto is one of the richest food sources of MK-7. However, the taste of natto is not appreciated by the western society. For this reason the active biological compound is produced as a capsule. Different techniques of encapsulation the vitamin can lead to different absorption profiles with intake. Therefore it is important to study influence of type of encapsulation technique on absorption of menaquinone-7.

This study is undertaken to compare absorption of menaquinones between two different encapsulation techniques. Absorption profiles of menaquinone-4 and menaquinone-7 of conventional softgel capsules and newly developed GellpelTM capsules are compared between each other.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-06
• Primary Completion: 2008-08
• Study Completion: 2008-08
• Study First Submitted: 2008-08-27
• Study First Submitted QC: 2008-08-27
• Study First Posted: 2008-08-28
• Status Verified: 2009-03
• Last Update Submitted: 2018-04-25
• Last Update Posted: 2018-04-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 16

Inclusion Criteria

• Healthy men and women between 20 and 30 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
• Subjects receiving corticoϊd treatment
• Subjects using oral anticoagulants
• Subject with (a history of) soy allergy
• Subjects using vitamin K containing multivitamins or vitamin K supplements
• Subjects with anaemia or subjects who recently donate blood.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
2	Vitamin K2 in Gelpell	Gelpell capsules
1	Vitamin K2 in softgel	softgel capsules

Primary Outcome Measures

Name	Time	Method
The mean difference in plasma concentration of MK-4 and MK-7 between the two types of capsules (softgel or gelpell)concerns the primary outcome measure.	4 weeks

Secondary Outcome Measures

Name	Time	Method
The mean difference in serum concentration of vitamin D3 between the two types of capsules (softgel or gelpell) concerns the secondary endpoint for this study.	4 weeks

Trial Locations

Locations (1)

VitaK BV / Maastricht University; 🇳🇱 Maastricht, Netherlands