Comparison of Bioavailability of Three Different Vitamin K2 Formulations
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 24
- Locations
- 1
- Primary Endpoint
- MK-7 absorption profiles
Study Overview
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 20 Years to 40 Years (Adult)
- Sex
- All
- Accepts 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)
Outcomes
Primary Outcomes
MK-7 absorption profiles
Time Frame: 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.
Secondary Outcomes
No secondary outcomes reported