Bioavailability of Micronutrients With a Special Focus on Vitamin K Dependent on Consumed Diet

NCT06921018 · tracked via the Priya Life Science Denmark tracker

Sponsor

University of Copenhagen

Phase

Not applicable

Started

2025-04-01

Last updated

2025-04-10

Condition(s) studied

Micronutrient Status

Investigational drug(s) / intervention(s)

change in diet

change in diet: the participants will either be assigned consumption of a vegan diet or their habitual average danish diet with a high intake of meat for the intervention period which is 4 weeks.

Study 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)

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 * 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 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

Primary outcome measure(s)

Differences in the status of micronutrients dependent on consumption of either a plant-based diet or an average Danish diet — From screening the last visit of the participant will take place after 10 weeks.
The status of the micronutrients will be assesed by analysing blood, feases and urine samples for biomarkers and concentration of the micronutrients. For vitamin K, we will measure the concentration of vitamin K vitamers in blood, feaces and urine and the concentration of the biomarkers MGP and OC in the blood samples.

Trial sites (1)

Facility	City	Region	Status
University of Copenhagen	Frederiksberg	Denmark

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Official registry record

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.

View NCT06921018 on ClinicalTrials.gov ↗ ← All trials in Denmark