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 @ 7:11 PM
Ignite Modification Date:
2025-12-24 @ 7:11 PM
NCT ID:
NCT03853603
Eligibility Criteria:
Inclusion Criteria:
* Subject is able and willing to follow the study protocol procedures to sign the Informed Consent Form prior to screening evaluations
* Overweight and obese women with BMI 25 - 35 kg/m2 (limits included)
* Age: 25 - 60 years
* Subject is in good physical and mental health as established by medical history, physical examination, electrocardiogram, vital signs, results of biochemistry, haematology
Exclusion Criteria:
* Relevant history or presence of any medical disorder potentially interfering with this study (heavy depression, diabetes, active cancer, severe liver disease, heavy cardiovascular diseases (e.g. stroke, heart attack))
* Chronic intake of medication/dietary supplements with impact on body weight or body composition or lipid modifying products (e.g. protein shakes, statins, omega-3 fatty acids, etc.) 2 months prior to screening or during the study; stable doses of e.g. hypertensive therapy and thyroid gland hormones are acceptable.
* Change in hormonal contraceptive during or at least 3 months before the study
* Consumption of any dietary supplement / fortified food (with exception of vitamin D and mineral supplements e.g. Ca, Mg)
* Low body fat mass measured at screening with BIA ( bioelectrical impedance analysis ) (Cut off-value: \<36% body fat).
* Weight loss intervention or recent body weight change \> 4.5 kg during last 3 months
* Diet high in vegetables and fruits ≥ 5 portions per day
* Vegan lifestyle
* Smoker \> 10 cigarettes / day
* Gastrointestinal diseases/conditions (colitis ulcerosa, Crohn's disease, peptic ulcers, celiac disease)
Healthy Volunteers:
True
Sex:
FEMALE
Minimum Age:
25 Years
Maximum Age:
60 Years
Study:
NCT03853603
Study Brief:
Protocol Section:
NCT03853603