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

NCT06921018 | Not Yet Recruiting

• 1 other identifier: BioMicro Prot. v1.1 PLANTEKOST
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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 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)

Conditions

Micronutrient Status

Keywords

Bioavailability; Micronutrients; Vitamin K; vitamin B2; Vitamin B12; zinc; iodine; haemoglobin

Outcome Measures

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.

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

Study Arms (2)

Vegan diet

EXPERIMENTAL

The participants will consume a vegan diet

Behavioral: change in diet

average habitual danish diet with high meat consumption

NO INTERVENTION

average habitual danish diet with high meat consumption

Interventions

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.

Also known as: diet

Vegan diet

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of Copenhagen: lead
• Technical University of Denmark: collaborator

Study Sites (1)

University of Copenhagen

Frederiksberg, 1958, Denmark

Location

MeSH Terms

Interventions

Diet

Intervention Hierarchy (Ancestors)

Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Study Officials

• Susanne G Bügel, Professor

  University of Copenhagen

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Marie B Jensen, PhD

CONTACT

+45 26 44 58 95; mariebj@nexs.ku.dk

Susanne G Bügel, Professor

CONTACT

+4535332490; shb@nexs.ku.dk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Head of Section

Study Record Dates

• First Submitted: March 12, 2025
• First Posted: April 10, 2025
• Study Start: April 1, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): June 30, 2031
• Last Updated: April 10, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)