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:
2025-12-24 @ 4:32 PM
Ignite Modification Date:
2025-12-24 @ 4:32 PM
NCT ID:
NCT01731366
Eligibility Criteria:
Inclusion Criteria:
* Body mass index (BMI): 25 - 35 kg/m2
* No medical prescribed diet
* Weight stable
* No blood donation during the study
* Intense sporting activities less than 10h/ week
* Alcohol consumption less than 14 units/ week (female) and 21 units/ week (male)
* Signed written consent
Exclusion Criteria:
* Pharmacological treatment; hypertension, diabetes and blood lipid regulation
* Lactating (or lactating, 6 weeks ago), pregnant (or pregnant, 3 months ago) or wish to become pregnant during the study
* Participation in another biomedical trial 1 month prior to study start
* Diagnosed with any form of diabetes, celiac disease or chronic pancreatitis
* Reported chronic gastrointestinal disorders
* Antibiotic treatment for 3 month prior to study start
* Intake of vitamin, mineral, or pre- or probiotic supplements for 1 month prior to study start
* Blood hemoglobin \< 7.0 mmol/l
* Blood donation within 1 month prior to study start
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT01731366
Study Brief:
Protocol Section:
NCT01731366