Comparison of Absorption of Vitamin K2

NCT00742768 | Completed

• 1 other identifier: MEC 08-3-012
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy

Keywords

absorption; encapsulation; menaquinone; Bio-availability

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• 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

Study Arms (2)

1

ACTIVE COMPARATOR

softgel capsules

Dietary Supplement: Vitamin K2 in softgel

2

ACTIVE COMPARATOR

Gelpell capsules

Dietary Supplement: Vitamin K2 in Gelpell

Interventions

Vitamin K2 in softgel DIETARY_SUPPLEMENT

4 softgel capsules containing 45 µg MK-7 and 5 µg vitamin D3 per capsule and 4 softgel capsules containing 30 µg MK-4 per capsule

1

Vitamin K2 in Gelpell DIETARY_SUPPLEMENT

4 Gelpell capsules containing 45 µg MK-7 and 5 µg vitamin D3 per capsule and 4 Gelpell capsules containing 30 µg MK-4 per capsule

2

Eligibility Criteria

• Age: 20 Years - 30 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Maastricht University Medical Center: lead
• VitaK: collaborator

Study Sites (1)

VitaK BV / Maastricht University

Maastricht, 6200 MD, Netherlands

Location

MeSH Terms

Interventions

Vitamin K 2

Intervention Hierarchy (Ancestors)

Vitamin K; Naphthoquinones; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Phytol; Diterpenes; Terpenes; Quinones; Polycyclic Compounds

Study Officials

• Cees Vermeer, PhD

  Maastricht University, VitaK BV

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 27, 2008
• First Posted: August 28, 2008
• Study Start: June 1, 2008
• Primary Completion: August 1, 2008
• Study Completion: August 1, 2008
• Last Updated: April 26, 2018

Record last verified: 2009-03

Locations

NL (1)