About this trial
Objectives
The main objectives are:
Study part I: to investigate the bioavailability of vitamin K vitamers (PK, MK-4, MK-7 and MK-9) in humans using 13C-labelled compounds
Hypotheses Study part I: it is hypothesized that there is a difference between the bioavailability of the different vitamers, with MK-9 having the highest bioavailability followed by MK-7, and then PK, while MK-4 will have the lowest bioavailability.
Participants will:
Study part I: In the pilot study and study part I, participants will visit NEXS for a test period where a 6.5-hour test day will be carried out and followed up with two short visits on the 2 consecutive days. In the pilot study, there will be one test period with frequent blood sampling (before and after ingestion of a labelled vitamin K vitamer) and urine and faeces sampling. The minimum duration for each participant in the pilot study will be 2.5 weeks. After analyses of the bioavailability of the vitamin K vitamers in the pilot study, results will be used to determine the time points for biological sampling (mainly blood) in study part I. Study part I is a cross-over study with 4 test periods and washout periods in between. The minimum duration for each participant will be 6 weeks.
Eligibility criteria
Qualifiers
Men and women
Between 18 and 65 years old (including both 18 and 65 year olds)
Danish-speaking
Willingness to consume/comply with consumption of study-related intervention products/diet
Disqualifiers
Daily smokers/users of all kinds of nicotine-containing products. Occasional smokers/user can be included if they are willing to refrain from all kinds of nicotine-containing products during the trial (from screening to end of trial)
Blood donation <3 months prior to study-related blood sampling
Intensive physical training (> 10 hours of strenuous physical activity per week)
Participation in other clinical studies at the time of the study
Trial design
Treatments tested in this trial
- Vitamin K
Treatment groups
Locations
1Map coordinates are unavailable for these locations. Locations are shown below instead.
Sponsors and collaborators
University of Copenhagen
Lead sponsor
Technical University of Denmark
Collaborator