Status:
NOT_YET_RECRUITING
Bioavailability of Micronutrients With a Special Focus on Vitamin K Dependent on Consumed Diet
Lead Sponsor:
University of Copenhagen
Collaborating Sponsors:
Technical University of Denmark
Conditions:
Micronutrient Status
Eligibility:
All Genders
18-65 years
Phase:
NA
Brief 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 hypot...
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 30 2031
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT06921018
Start Date
April 1 2025
End Date
June 30 2031
Last Update
April 10 2025
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
University of Copenhagen
Frederiksberg, Denmark, 1958