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NOT YET RECRUITING

NCT06921018

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

Sponsor: University of Copenhagen

View on ClinicalTrials.gov

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)

Official title: Bioavailability of Micronutrients With a Special Focus on Vitamin K - Study Part II: PLANTEKOST

Key Details

Gender

All

Age Range

18 Years - 65 Years

Study Type

INTERVENTIONAL

Enrollment

Start Date

2025-04-01

Completion Date

2031-06-30

Last Updated

2025-04-10

Healthy Volunteers

Yes

Conditions

Micronutrient Status

Interventions

BEHAVIORAL

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.

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

Locations (1)

University of Copenhagen

Frederiksberg, Denmark