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.
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
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
Crossover
Vitamin K
Dietary supplementeach participant will recive one dose of each of the four vitamin K vitamers but in different orders (4 different orders).
13C-labelled vitamin K vitamers in blood samples
The area under the curve for the different 13C-labelled vitamin K vitamers will be compared from blood samples.
13C-labelled vitamin K vitamers in fecal samples
The amount of 13C-labelled vitamin K vitamers in the feces will be analysed
13C-lebelled vitamin K vitamers in urine samples
The amount of 13C-labelled vitamin K vitamers in the urine will be analysed
Map coordinates are unavailable for these locations. Locations are shown below instead.
DenmarkClick on the lead sponsor to view all of their trials.
University of Copenhagen
Lead sponsor
Technical University of Denmark
Collaborator
This trial is not recruiting at the moment. You can still explore other options:
