Bioavailability, Bioequivalence
Conditions
Keywords
vitamin K2, menaquinone-7, bioavailability
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.
Interventions
DIETARY_SUPPLEMENTMenaQ7 M-1500 capsules
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.
DIETARY_SUPPLEMENTGnosis P-1000 capsules
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.
DIETARY_SUPPLEMENTGnosis M-1500 capsules
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.
Sponsors
Maastricht University Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
20 Years to 40 Years
Healthy volunteers
Yes
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
Netherlands
Outcome results
None listed