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 @ 12:19 AM
Ignite Modification Date:
2025-12-25 @ 12:19 AM
NCT ID:
NCT05343858
Eligibility Criteria:
Inclusion Criteria:
* Men and women from 18 to 65 years old.
* Body Mass Index (BMI) ≥25 and \<40 kg/m2.
* Cardiovascular risk \<10%
* Adequate cultural level and understanding
* Agree to participate in the study
Exclusion Criteria:
* Subjects with BMI ≥40 or \<25 kg /m2
* Subjects diagnosed with Diabetes Mellitus.
* Subjects with dyslipidemia on pharmacological treatment
* Subjects with hypertension on pharmacological treatment
* Subjects with established diagnosis of eating disorder
* Smokers or those subjects with high alcohol consumption
* Subjects under pharmacological treatment
* Subjects with large weight fluctuations of more than 4 kg or who have undergone in six months a weight loss diet
* Subjects with sensory problems
* Subjects with gastrointestinal diseases that affect the digestion or absorption of nutrients
* Pregnant or breastfeeding women
* Women with menstrual irregularities
* Subjects with intense physical activity
* Subjects with food allergies to meals included in breakfast, study product or lunch or that reject their consumption
* Subjects with a diagnosis of celiac disease or a gluten intolerance
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT05343858
Study Brief:
Protocol Section:
NCT05343858