Bioavailability of Different Vitamin K Vitamers Studied Using 13C-labelled Vitamin K Vitamers

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorUniversity of Copenhagen

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

20 Participants
are divided into 4 treatment groups

Locations

1

Map coordinates are unavailable for these locations. Locations are shown below instead.

University of Copenhagen Status unavailable 1958, Frederiksberg CDenmarkDenmark

Sponsors and collaborators

University of Copenhagen

Lead sponsor

Technical University of Denmark

Collaborator