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 @ 12:34 AM
Ignite Modification Date:
2025-12-25 @ 12:34 AM
NCT ID:
NCT02737267
Eligibility Criteria:
Inclusion Criteria:
* Body Mass Index (BMI) between 25 and 40 kg/m2
* Physical examination and vital signs normal, or is considered abnormal, but clinically insignificant by researcher.
* In the case of individuals with chronic stable dose drug treatment and during the last 3 previous months at baseline, the investigator will assess their possible inclusion.
Exclusion Criteria:
* BMI less than 25 or higher than 40 kg/m2
* Pregnant women
* Breastfeeding period. If artificial feeding until 6 months after birth.
* Type 1 diabetes
* Severe kidney diseases
* Severe digestive system diseases
* Electrolyte disorders (disorders of sodium, potassium, calcium, chlorine, phosphorus, magnesium)
* Acute cardiovascular diseases
* Cancer
* Anemia
* Eating disorders
* Recent prescription drug treatment (without stable doses scheduled)
* Drug therapy that can influence weight loss as corticosteroids.
* Some type of cognitive impairment and / psychic
* Subjects in which poor collaboration or, in the investigator's opinion, have difficulty following the procedures of the study is foreseen
* Lack of commitment (at the discretion of the investigator) with the intervention, suspected non-compliance, or real difficulties to follow the development of the study.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT02737267
Study Brief:
Protocol Section:
NCT02737267