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 @ 2:05 AM
Ignite Modification Date:
2025-12-25 @ 2:05 AM
NCT ID:
NCT01066260
Eligibility Criteria:
Inclusion Criteria:
* Body Masss Index (BMI) 25 - 30 kg/m2
* Healthy (determined by medical questionnaire)
* Able to commit to the duration of the study
* Providing consent for participation
Exclusion Criteria:
* History of cardiovascular disease (CVD), diabetes, cancer, renal, thyroid or hepatic disease
* History of gastrointestinal surgery
* History of sleep disorders
* Recent bacterial infection (\< 2 weeks)
* Weight loss \> 5 kg in the last 3 months
* Under antibiotics or treatments (medical or nutritional program) affecting body weight, appetite, energy expenditure lipid-lowering, hypertension or inflammation or glucose control for the last 3 months or taking hormone replacement therapy
* Excessive consumption of products enriched in probiotics (\> 4 servings per week) within the last 4 weeks before the start of the study
* History of drug or alcohol abuse (\> 2 drinks daily)
* Regular smokers (more than 5 cigarettes a day)
* Not eating breakfast regularly or eating breakfast before 6h00.
* Not willing to eat any of the foods to be served in the study for any reason
* Physical activity level \> 150 min of moderate or intense exercise per week
* Concurrent or recent intervention study (within 60 days)
Healthy Volunteers:
True
Sex:
MALE
Minimum Age:
20 Years
Maximum Age:
50 Years
Study:
NCT01066260
Study Brief:
Protocol Section:
NCT01066260