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:
2025-12-26 @ 4:01 PM
Ignite Modification Date:
2025-12-26 @ 4:01 PM
NCT ID:
NCT02836106
Eligibility Criteria:
Inclusion Criteria:
* The study will include both men and women aged 18-70 years with the aim of an even age and gender balance.
* Participants in the healthy group will need to have a body mass index (BMI) between 18.5 - 24.9 kg/m2 and a waist circumference (WC) of \<94 cm for men and\<80 cm for women.
* Participants in the obese group will need to have a BMI of ≥25 kg/m2 and a waist circumference of ≥94 cm for men and ≥80 cm for women.
* All subjects must be willing to eat three slices of bread with a dairy product and jam as breakfast.
Exclusion Criteria:
* BMI \<18.5 kg/m2 or \>25 kg/m2 in the healthy group and \<25 kg/m2 in the obese group
* WC ≥94 for men and ≥80 cm for women in the healthy group, \<94/80 cm for men/women in the obese group
* Weight change of ± 5 % of body weight in the last three months
* TG ≥1.3 mmol/L in the healthy group
* CRP \>10 mg/L
* Total cholesterol \>6.1 mmol/L for subjects 18-29 years, \>6.9 mmol/L for subjects 30-49 years and \>7.8 mmol/L for subjects ≥50 years old
* Blood pressure \>160/100 mm Hg
* Comorbidities including diabetes type I and II (blood glucose ≥7 mmol/L fasting), coronary heart disease, haemophilia, anaemia (hemoglobin \<120 gram/L), gastro intestinal disease and hyperthyroidism (TSH \>4 mU/L)
* Pregnant or lactating
* Allergic or intolerant to gluten, milk protein and/or lactose
* Use of medications affecting lipid metabolism or inflammation
* Unwilling to seponate omega-3 rich supplements four weeks prior to screening and during the study period
* Hormone treatment (stabile dose of contraception or thyroxin for the last three months excepted)
* Blood donation two months prior to test day 1 or during the study period
* Tobacco smoking
* Excessive regular alcohol consumption (\>40 grams per day) or prior to the test day
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT02836106
Study Brief:
Protocol Section:
NCT02836106