Bio-equivalence Study

Study Overview
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Brief Summary
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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
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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.

Official Title
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Comparison of Bioavailability of Three Different Vitamin K2 Formulations

Conditions
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Bioequivalence, Bioavailability

Intervention / Treatment
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* Dietary Supplement: MenaQ7 M-1500 capsules
* Dietary Supplement: Gnosis P-1000 capsules
* Dietary Supplement: Gnosis M-1500 capsules


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Gnosis P-1000 capsules<br>MK-7 capsules containing 75 µg of MK-7 (source: Gnosis, Italy). | Dietary Supplement: Gnosis P-1000 capsules<br>* The study participants will receive three different types of capsules as a single dose (75 μg of MK-7/day): MenaQ7 M-1500 capsule Gnosis P-1000 capsule Gnosis M-1500 capsule Every two weeks, participants switch to another type of capsule; the washout period will therefore be two weeks.<br>|
| Active Comparator: Gnosis M1500 capsules<br>MK-7 capsules containing 75 µg of MK-7 (source Gnosis, Italy). | Dietary Supplement: Gnosis M-1500 capsules<br>* The study participants will receive three different types of capsules as a single dose (75 μg of MK-7/day): MenaQ7 M-1500 capsule Gnosis P-1000 capsule Gnosis M-1500 capsule Every two weeks, participants switch to another type of capsule; the washout period will therefore be two weeks.<br>|
| Active Comparator: MenaQ7 M-1500 capsules<br>MK-7 capsules containing 75 µg of MK-7 (source: Nattopharma, Norway) | Dietary Supplement: MenaQ7 M-1500 capsules<br>* The study participants will receive three different types of capsules as a single dose (75 μg of MK-7/day): MenaQ7 M-1500 capsule Gnosis P-1000 capsule Gnosis M-1500 capsule Every two weeks, participants switch to another type of capsule; the washout period will therefore be two weeks.<br>Dietary Supplement: Gnosis P-1000 capsules<br>* The study participants will receive three different types of capsules as a single dose (75 μg of MK-7/day): MenaQ7 M-1500 capsule Gnosis P-1000 capsule Gnosis M-1500 capsule Every two weeks, participants switch to another type of capsule; the washout period will therefore be two weeks.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| MK-7 absorption profiles | 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. | 9 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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vitamin K2, menaquinone-7, bioavailability