Comparison of Absorption of Vitamin K2

Maastricht University Medical Center16 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Healthy

Interventions

Eligibility

Sex: ALLMin age: 20 YearsMax age: 30 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

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.

Time frame: 4 weeks

Secondary Outcomes

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.