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 @ 3:20 AM
Ignite Modification Date:
2025-12-25 @ 3:20 AM
NCT ID:
NCT02064205
Eligibility Criteria:
Inclusion Criteria:
1. Healthy, female participants aged 20-45 years inclusive
2. BMI: 20-30 kg/m2 inclusive
3. Written consent regarding participation after full information regarding all details of the study
4. Normal Dutch eating habits (consuming mostly three main meals per day; used to eat bread for lunch)
Exclusion Criteria:
1. Pregnancy
2. On-going or recent treatment for diabetes, hypertension, coronary heart disease, psychiatric conditions, inflammatory chronic disease - rheumatoid arthritis, Crohn Disease, ulcerous colitis, chronic constipation, eating disorders, or any disease condition which interferes with ADME of the investigational product
3. Reported postmenopausal
4. Having menstruation problems, e.g. PCOS
5. Reported to be on a slimming diet or other dietary treatment (currently or during last two months, like vegetarian diet, lactose restricted diet etc.)
6. Aversion towards products (yoghurt) provided in the study
7. On-going use of any slimming preparations
8. Any kind of dysfunction of digestive tract, food allergy, chronic constipation, recent/actual gastroenteritis
9. Restrained eaters (score DEBQ \>3.4)
10. Participants consuming more than 23g of dietary fiber per day - P75 according to the Dutch National Food Consumption Survey - (as assessed with a general short questionnaire which gives estimation on the fiber intake. Exact fiber intake will not be calculated)
11. Smoker in the last 3 months
12. Heavy coffee drinkers (more than 6 cups a day)
13. High level of physical activity: Participants who perform more than 3 hours of intense training/sport activity per week (this will not include normal cycling transport)
14. Heavy alcohol consumers, no more than 14 units per week (1 unit represents 1 standard glass/portion of alcohol, independent of the type of alcoholic drink).
Remark:
When enough subjects are eligible (\> 32), the women with the highest BMI will be selected to participate. At least 50% of the subjects will have a BMI ranging of 25-30. Also at least 50% of the women will be in the age range of 25-45 years. When more than 32 subjects are eligible the eldest subjects will be included.
With respect to eligibility of the subjects:
the BMI criterion always comes for age criterion, meaning that overweight is stressed to be of more importance for this study than age. Overweight will always come first, even when already \> 50% of the women with a BMI 25-30 have been included. In this way the overweight group of women will be studied as much as possible.
Healthy Volunteers:
True
Sex:
FEMALE
Minimum Age:
20 Years
Maximum Age:
45 Years
Study:
NCT02064205
Study Brief:
Protocol Section:
NCT02064205