Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 4:31 AM
Ignite Modification Date:
2025-12-25 @ 4:31 AM
NCT ID:
NCT06921018
Eligibility Criteria:
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
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT06921018
Study Brief:
Protocol Section:
NCT06921018