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:
2025-12-24 @ 10:46 PM
Ignite Modification Date:
2025-12-24 @ 10:46 PM
NCT ID:
NCT06959069
Eligibility Criteria:
Inclusion Criteria:
* Healthy subjects
* Adult subjects - age: between 18 and 65 years old
* Subjects with a BMI between 18.5 and 29.9 kg/m\^2
* Male and female subjects
Exclusion Criteria:
* Subjects \< 18 years old
* Subjects with Diabetes Mellitus (type 1 and type 2)
* Pregnant and/or breastfeeding and/or postpartum women
* Underweight subjects (BMI \< 18.5)
* Obese subjects (BMI \> 30)
* Subjects with confirmed sleep disorders (requiring CPAP or sleep medication (sleeping pills))
* Subjects with renal failure (GFR \< 30 ml/min/1.73 m\^2) or liver disorder
* Subjects with serious cardiovascular, respiratory, neurological, or metabolic medical conditions
* Subjects with malignant tumors
* Subjects with a serious mental disorder requiring medication (e.g., antidepressants or anxiolytics)
* Subjects with eating disorders
* Subjects who have undergone major surgery or have been hospitalized due to major medical condition (surgery, stay in intensive care) within the last one year
* Subjects who have lost more than 10% of their body weight within the last one year
* Subjects actively participating in a weight-loss program
* Subjects with alcohol use disorder (maximum 10 standard alcoholic drinks per week, 2 standard alcoholic drinks per day)
* Subjects with substance use disorder
* Subjects unable to provide informed consent
* Subjects who do not participate simultaneously in another clinical trial
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT06959069
Study Brief:
Protocol Section:
NCT06959069