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

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 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 criteria

This trial accepts healthy volunteers

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)

Trial design

Design model

Parallel

Treatments tested in this trial

  • change in diet

    Behavioral

    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.

Treatment groups

20 Participants
are divided into 2 treatment groups
Group A: Vegan dietExperimental treatment 1 intervention
Group B: average habitual danish diet with high meat consumptionNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

Differences in the status of micronutrients dependent on consumption of either a plant-based diet or an average Danish diet

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.

Time frame
From screening the last visit of the participant will take place after 10 weeks.

Secondary outcomes

Other outcomes

Sponsors and contacts

Click 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: