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 @ 3:08 AM
Ignite Modification Date:
2025-12-25 @ 3:08 AM
NCT ID:
NCT04962633
Eligibility Criteria:
Inclusion Criteria:
* healthy subjects;
* men and women;
* age 18-65 years;
* 25 kg/m2 ≤ BMI ≤ 35 kg/m2;
* habitual daily pasta consumption (≥ 1 portion/day);
* habitual diet characterized by absence of any food supplements and alternative medication, probiotics and prebiotics, whole grain and/or fiber enriched foods;
* intake of fruit/vegetables \< 3 servings/day;
* low level of physical activity (\< 500 metabolic equivalent min/week);
* signed written informed consent.
Exclusion Criteria:
* food allergies and intolerances and celiac disease;
* gastrointestinal diseases;
* relevant diseases;
* pregnant or breastfeeding;
* previous abdominal surgery;
* hypertriglyceridemia (Triglycerides \> 200 mg/dL);
* hypercholesterolemia (Total cholesterol \> 200 mg/dL);
* hyperglycaemia (glycaemia ≥ 110 mg/dL);
* hypertension (arterial blood pressure ≥140/90 mm Hg);
* weight loss ≥ 3 kg within 2 months before the study;
* antibiotics treatment within 3 months before the study;
* any medication (different from antibiotics) at the enrollment and within 2 months before the study;
* habitual diet characterized by high fruit and vegetables intakes (\>3 portion/die);
* high level of physical activity;
* Alcohol consumption ≥ 3 alcohol units per day;
* simultaneous participation in other trial.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT04962633
Study Brief:
Protocol Section:
NCT04962633