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 @ 4:04 AM
Ignite Modification Date:
2025-12-25 @ 4:04 AM
NCT ID:
NCT02621502
Eligibility Criteria:
Inclusion Criteria:
* Men and women from 18 to 65 years old.
* Body mass index (BMI) ≥25 and \<30 kg/m2.
* Adequate cultural level and understanding for the clinical trial.
* Signed informed consent
Exclusion Criteria:
* Individuals with BMI ≥30 or \<25 kg/m2
* Vegetarians or individuals with a fiber intake ≥30 g/day
* Individuals diagnosed with Diabetes Mellitus
* Individuals with dyslipidemia on pharmacological treatment
* Individuals with hypertension on pharmacological treatment
* Smokers or heavy drinking individuals (\>2-3 servings/day in men and \> 1 serving/day in women (1 serving=1 glass of wine or 1 bottle of beer))
* Individuals with large weight fluctuations or who have undergone in recent months a weight loss diet
* Individuals with gastrointestinal diseases that affect the digestion or the absorption of nutrients
* Individuals receiving at least the preceding 2 months a pharmacological treatment that modifies the lipid profile (for example, statins, fibrates, diuretics, corticosteroids, oral antidiabetic medications)
* Pregnant or breastfeeding women
* Women with menstrual irregularities (absence of menstrual cycle at least 2 months prior)
* Individuals with intense physical activity
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT02621502
Study Brief:
Protocol Section:
NCT02621502