Vitamin K: each participant will recive one dose of each of the four vitamin K vitamers but in different orders (4 different orders).
Study summary
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
Sex
ALL
Min age
18 Years
Max age
65 Years
Healthy volunteers
Accepted
Inclusion Criteria:
* 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
* Willing to take 10 µg vitamin D3/day and omit intake of all other (vitamins and mineral) supplements before and during the trial
* BMI ≤ 30.0 kg/m2
Exclusion Criteria:
* 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
* Pregnant, lactating or planning to become pregnant within the study period
* Habitual alcohol intake above current recommendation (\> 10 alcoholic units/week)
* History of cancer within the past five (5) years except basal cell skin cancer and cervix
* Diagnosed with chronic inflammation disorders
* Diagnosed with gastrointestinal diseases
* Diagnosed with bone related diseases
* Diagnosed with psychiatric disorder including depression that requires medical treatment
* Medical treatment of diabetes
* Medical treatment of cardiovascular related disease
* Surgical change of the gastrointestinal tract (removal of appendix is allowed)
* Use of prescription medication that can affect their safety or impact on data
* Inability, physically or mental, to comply with the procedure required by the study protocol and evaluated by the principal investigator (PI), study manager or clinical responsible
* Medical treatment with anticoagulation medication (warfarin-like types)
* Allergy or intolerance related to intervention products
Primary outcome measure(s)
13C-labelled vitamin K vitamers in blood samples — from test day 1 until the end of the last washout period 5 weeks after test day 1. 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 — from test day 1 until the end of the last washout period 5 weeks after test day 1. The amount of 13C-labelled vitamin K vitamers in the feces will be analysed
13C-lebelled vitamin K vitamers in urine samples — from test day 1 until the end of the last washout period 5 weeks after test day 1. The amount of 13C-labelled vitamin K vitamers in the urine will be analysed
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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