Micronutrient StatusBioMicroNCT06921018
Bioavailability of Micronutrients With a Special Focus on Vitamin K Dependent on Consumed Diet
A study testing change in diet in people with Micronutrient Status, run by University of Copenhagen at 1 site in Denmark.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Micronutrient Status
- What is being tested?
- change in diet
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Apr 2025to 30 Jun 2031
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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
Show all 17Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Denmark1 site
University of Copenhagen
Frederiksberg, 1958
Marie B Jensen, PhD, +4526445895, mariebj@nexs.ku.dk
Susanne G Bügel, Professor, +4535332490, shb@nexs.ku.dk
About this study
Official title: Bioavailability of Micronutrients With a Special Focus on Vitamin K - Study Part II: PLANTEKOST
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)
Read the detailed description
Overall study design Study part II (n= 16 completers): A 4-week randomised parallel intervention trial comparing status of some micronutrients (with main focus on MK-9 and ferritin) after consumption of a plant-based diet compared to an average Danish diet
In study part II, participants will be randomised to either plant-based or an average Danish (meat-based) diet for 4-weeks. The participants will visit NEXS for two test days, before and after the 4-week intervention period where fasting blood will be drawn. Prior to the two test days the participants will complete a 3-day weighed dietary registration (WDR) and collect faecal and urine samples. The minimum duration for each participant will be 33days.
It is required that the participants' vitamin D status is stable. Therefore, a run-in period of up to 6-week with daily supplementation of vitamin D will be required before the first test day.
Detailed study design of part II Prerequisites Six weeks before the first test day it is required that participants have been supplemented with 10 µg vitamin D3/day (recommended daily intake) and restrain from all other types of (vitamins and mineral) supplementation. The vitamin D supplements will be provided free of charge. On day -5 (or at screening) the participants will show up at NEXS where they will receive containers and cooler bags for urine and faecal sampling. The participants will further get written and oral instructions for the WDR. Prior to Day 0, the participants will perform a 3-day WDR, collect a spot faecal sample and a 24-hour urine sample. Prior to the test day, alcohol is prohibited 48 hours before, high-intensity physical activity is prohibited 24 hours before and the participants will fast for a minimum of 12 hours before. The participants are allowed to drink ½ L of tap water during the fasting period.
Test days On Day 0, the participants will show up fasting at NEXS and one fasting blood sample will be collected (baseline blood sample). The participants will have a session with a dietician, or other delegated personnel, where they will be introduced to their assigned diets (both including daily supplementation with 10 µg vitamin D3) and asked to start the 4-week intervention. On Day 28 (±3 days), the participants will have their second test day at NEXS where one blood sample will be drawn. Prior to the second test days (Day28), they repeat the 3-day WDR, sampling of faeces and urine, and prerequisites related to alcohol intake, physical activity and fasting is required as described above.
Intervention period During the 4 weeks, the participants will show up at NEXS 1-2 days per week to receive new products and if needed they can ask for recipes, guidelines and feedback/advice from a trained dietician. Once a week they will be asked to collect a spot urine sample in the morning on the day they visit NEXS. During the third week, participants will in addition to the above mentioned also have instructions for the WDR and collections of urine and faeces repeated, and material delivered.
- Conditions
- Micronutrient Status
- Being tested
- change in diet
- Keywords
- Bioavailability, Micronutrients, Vitamin K, vitamin B2, Vitamin B12, zinc, iodine, haemoglobin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
change in dietBehavioural
Also called 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 group | Role | What they receive |
|---|---|---|
| Vegan diet | Experimental | The participants will consume a vegan diet Receives: Behavioral: change in diet |
| average habitual danish diet with high meat consumption | No intervention | average habitual danish diet with high meat consumption |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From screening the last visit of the participant will take place after 10 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2025
- Study start1 Apr 2025 (estimated)
- Primary completionDec 2026 (estimated)
- Study completion30 Jun 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Micronutrient StatusStudies of the same condition, open and under way.
- More trials run by University of CopenhagenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Copenhagen
- Sponsor type
- University, hospital or other
- Collaborators
- Technical University of Denmark
- Responsible party
- Principal investigator, Susanne Bügel, University of Copenhagen
- Investigators
- Susanne G Bügel, Professor, Principal investigator, University of Copenhagen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06921018
- Sponsor's protocol ID
- BioMicro Prot. v1.1 PLANTEKOST
- Acronym
- BioMicro
- Status last verified
- Apr 2025
- First submitted
- 12 Mar 2025
- Last updated
- 10 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: We will report anonymized data for publications of the result.
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bioavailability of Micronutrients With a Special Focus on Vitamin K - Study Part II: PLANTEKOST
- ClinicalTrials.gov ID
- NCT06921018
- Acronym / sponsor ID
- BioMicro / BioMicro Prot. v1.1 PLANTEKOST
- Conditions
- Micronutrient Status
- Keywords
- Bioavailability, Micronutrients, Vitamin K, vitamin B2, Vitamin B12, zinc, iodine, haemoglobin
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- University of CopenhagenUniversity, hospital or other
- Collaborators
- Technical University of Denmark
- Study start
- 1 Apr 2025 (estimated)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- 30 Jun 2031 (estimated)
- First posted
- 10 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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)
Detailed description
Overall study design Study part II (n= 16 completers): A 4-week randomised parallel intervention trial comparing status of some micronutrients (with main focus on MK-9 and ferritin) after consumption of a plant-based diet compared to an average Danish diet
In study part II, participants will be randomised to either plant-based or an average Danish (meat-based) diet for 4-weeks. The participants will visit NEXS for two test days, before and after the 4-week intervention period where fasting blood will be drawn. Prior to the two test days the participants will complete a 3-day weighed dietary registration (WDR) and collect faecal and urine samples. The minimum duration for each participant will be 33days.
It is required that the participants' vitamin D status is stable. Therefore, a run-in period of up to 6-week with daily supplementation of vitamin D will be required before the first test day.
Detailed study design of part II Prerequisites Six weeks before the first test day it is required that participants have been supplemented with 10 µg vitamin D3/day (recommended daily intake) and restrain from all other types of (vitamins and mineral) supplementation. The vitamin D supplements will be provided free of charge. On day -5 (or at screening) the participants will show up at NEXS where they will receive containers and cooler bags for urine and faecal sampling. The participants will further get written and oral instructions for the WDR. Prior to Day 0, the participants will perform a 3-day WDR, collect a spot faecal sample and a 24-hour urine sample. Prior to the test day, alcohol is prohibited 48 hours before, high-intensity physical activity is prohibited 24 hours before and the participants will fast for a minimum of 12 hours before. The participants are allowed to drink ½ L of tap water during the fasting period.
Test days On Day 0, the participants will show up fasting at NEXS and one fasting blood sample will be collected (baseline blood sample). The participants will have a session with a dietician, or other delegated personnel, where they will be introduced to their assigned diets (both including daily supplementation with 10 µg vitamin D3) and asked to start the 4-week intervention. On Day 28 (±3 days), the participants will have their second test day at NEXS where one blood sample will be drawn. Prior to the second test days (Day28), they repeat the 3-day WDR, sampling of faeces and urine, and prerequisites related to alcohol intake, physical activity and fasting is required as described above.
Intervention period During the 4 weeks, the participants will show up at NEXS 1-2 days per week to receive new products and if needed they can ask for recipes, guidelines and feedback/advice from a trained dietician. Once a week they will be asked to collect a spot urine sample in the morning on the day they visit NEXS. During the third week, participants will in addition to the above mentioned also have instructions for the WDR and collections of urine and faeces repeated, and material delivered.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vegan diet | Experimental | Behavioral: change in dietThe participants will consume a vegan diet |
| average habitual danish diet with high meat consumption | No intervention | –average habitual danish diet with high meat consumption |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (17 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| change in dietAlso: dietthe 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. | Behavioural | Vegan diet |
Primary outcome
Differences in the status of micronutrients dependent on consumption of either a plant-based diet or an average Danish diet
Time frame: 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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Apr 2025.
- Individual participant dataSharing planned: No. We will report anonymized data for publications of the result.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Susanne G Bügel, Professor principal investigator
University of Copenhagen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing change in diet in people with Micronutrient Status, run by University of Copenhagen at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 10 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Marie B Jensen, PhD (+45 26 44 58 95, mariebj@nexs.ku.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Differences in the status of micronutrients dependent on consumption of either a plant-based diet or an average Danish diet (time frame: From screening the last visit of the participant will take place after 10 weeks.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Apr 2025.