Bio-equivalence Study

Not Applicable

Completed

• Conditions: Bioequivalence; Bioavailability
• Interventions: Dietary Supplement: MenaQ7 M-1500 capsules; Dietary Supplement: Gnosis P-1000 capsules; Dietary Supplement: Gnosis M-1500 capsules

• Registration Number: NCT01638143
• Lead Sponsor: Maastricht University Medical Center

Brief Summary

The primary objective of this study is to compare absorption of vitamin K2 (menaquinone-7) after intake of three different vitamin K2 supplements.

Detailed Description

Several manufacturers are producing vitamin K2 raw material in different forms, namely oil and powder. To ensure bioequivalence of different vitamin K2 sources, the investigators are interested to compare the bioavailability of three different vitamin K2 formulations that are already commercially available. Two different oils and one powder product will be compared in this randomized cross-over trial. The investigators hypothesize that different vitamin K2 sources give no differences in bioavailability of vitamin K2.

Study Timeline

• Study Start: 2010-11
• Primary Completion: 2011-01
• Study Completion: 2011-08
• Status Verified: 2012-07
• Study First Submitted: 2012-07-09
• Study First Submitted QC: 2012-07-10
• Last Update Submitted: 2012-07-10
• Study First Posted: 2012-07-11
• Last Update Posted: 2012-07-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

Inclusion Criteria

• Healthy men and women, aged between 20 and 40 years
• Normal body weight and height (18.5 kg/m2 < BMI < 30 kg/m2)
• Stable body weight (weight gain or loss < 3 kg in past 3 mo)
• Written consent to take part in the study
• Agreement to adhere to dietary restrictions required by the protocol

Exclusion Criteria

• Abuse of drugs and/or alcohol
• Use of vitamin supplements containing vitamin K
• Soy allergy
• Pregnancy
• a history of) metabolic or gastrointestinal diseases including hepatic disorders
• Chronic degenerative and/or inflammatory diseases, e.g. diabetes mellitus, renal failure
• Use of oral anticoagulants
• Corticoid treatment
• Subjects with anaemia or subjects who recently donated blood or plasma
• Systemic treatment or topical treatment likely to interfere with coagulation metabolism (salicylates, antibiotics)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
MenaQ7 M-1500 capsules	MenaQ7 M-1500 capsules	MK-7 capsules containing 75 µg of MK-7 (source: Nattopharma, Norway)
Gnosis P-1000 capsules	Gnosis P-1000 capsules	MK-7 capsules containing 75 µg of MK-7 (source: Gnosis, Italy).
MenaQ7 M-1500 capsules	Gnosis P-1000 capsules	MK-7 capsules containing 75 µg of MK-7 (source: Nattopharma, Norway)
Gnosis M1500 capsules	Gnosis M-1500 capsules	MK-7 capsules containing 75 µg of MK-7 (source Gnosis, Italy).

Primary Outcome Measures

Name	Time	Method
MK-7 absorption profiles	9 weeks	The purpose of this study is to compare the MK-7 absorption profiles after intake of three different vitamin K2 (MK-7) products that are already on the market. The main study parameter is therefore the calculated AUC value from the individual MK-7 absorption profiles.

Trial Locations

Locations (1)

VitaK BV / Maastricht University Medical Center; 🇳🇱 Maastricht, Netherlands