Bioavailability of Micronutrients With a Special Focus on Vitamin K Dependent on Consumed Diet (NCT06921018) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Bioavailability of Micronutrients With a Special Focus on Vitamin K Dependent on Consumed Diet
Denmark20 participantsStarted 2025-04-01
Plain-language summary
Objectives
The main objectives are:
• Study part II: to investigate the effect of a plant-based diet on micronutrient status compared to an average Danish diet
Hypotheses Study part II: it is hypothesised that the status of some micronutrients is lower after intake of a plant-based diet compared to an average Danish diet.
Participants will:
Study part II: consume either a vegan diet or an average danish diet with a high meat intake for 4 weeks. The total study period for the participants is estimated to 6 weeks (from screening to paticipants last visit)
Who can participate
Age range
18 Years – 65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
* Habitual consumption of meat at dinner minimum 5 times per week. Meat is defined as red meat and poultry, where red meat is consumed at dinner at least 2 out of 5 times per week (fish consumption is not included in the "5 per week" meat definition).
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 psychi…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Differences in the status of micronutrients dependent on consumption of either a plant-based diet or an average Danish diet
Timeframe: From screening the last visit of the participant will take place after 10 weeks.