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 @ 7:16 PM
Ignite Modification Date:
2025-12-24 @ 7:16 PM
NCT ID:
NCT02388503
Eligibility Criteria:
Inclusion criteria:
* Body mass index (BMI) ≥ 18.0 and ≤ 30.0 kg/m2.
* Apparently healthy males and females: no medical conditions which might affect the study measurements including diabetes type 1 and type 2, gastrointestinal dysfunction, gastrointestinal surgery and inflammatory diseases.
* Fasting blood glucose value of subjects ≥ 3.4 and ≤ 6.1 mmol/litre (i.e. 62-110 mg/dl) at screening.
Exclusion criteria:
* Use of antibiotics within 3 months before day 1; use of any other medication except paracetamol, within 14 days before day 1.
* Blood donation in the past 3 months and/or during the study.
* Reported intense sporting activities \> 10 h/week.
* Consumption of \> 14 units (female subjects) and \> 21 units (male subjects) alcoholic drinks in a typical week.
* Reported dietary habits: medically prescribed diet, slimming diet, not used to eat 3 meals a day, vegetarian.
* If female, is pregnant (or has been pregnant during the last \< 3 months) or will be planning pregnancy during the study period.
* If female, is lactating or has been lactating in the 6 weeks before screening and/or during the study period.
* Dislike, known allergy or intolerance to test products or other food products provided during the study.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
50 Years
Study:
NCT02388503
Study Brief:
Protocol Section:
NCT02388503