Comparison of Absorption of Vitamin K2

Maastricht University Medical Centre (MUMC)

Status: Completed

Conditions: Healthy

Treatments: Dietary Supplement: Vitamin K2 in Gelpell; Dietary Supplement: Vitamin K2 in softgel

Study type: Interventional

Funder types: Other

Identifiers

NCT00742768

MEC 08-3-012

Details and patient eligibility

About

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.

Enrollment: 16 patients

Sex: All

Ages: 20 to 30 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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16 participants in 2 patient groups

1

Active Comparator group

Description:

softgel capsules

Treatment:

Dietary Supplement: Vitamin K2 in softgel

2

Active Comparator group

Description:

Gelpell capsules

Treatment:

Dietary Supplement: Vitamin K2 in Gelpell