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 @ 2:50 AM
Ignite Modification Date:
2025-12-25 @ 2:50 AM
NCT ID:
NCT04618133
Eligibility Criteria:
Inclusion Criteria:
* Clinical criteria
* Men and premenopausal women
* Age 25-50 years
* BMI 25-34 kg/m2
* Stable weight (maximum ± 2 kg of usual body weight) over the previous 3 months
* Stable body fat mass (maximum ± 1 kg of body fat mass) during the run-in phase
* Eating window ≥ 12 hours during the run-in phase
* Morning chronotype
* Work-related criteria
* Daytime work at least 3 days per week over the previous 1 month and planned during the study
* Study-related criteria
* Able to give informed consent and follow the study procedures for the entire duration
* Confident use of a smartphone and able to take regular pictures of food/drinks
Exclusion Criteria:
* Clinical criteria
* Pregnant and breastfeeding women, plans for maternity during the study
* On a diet, intermittent fasting, in a weight management program over the previous 3 months or planned during the study
* Eating disorder(s) or prior bariatric surgery
* Diabetes with hypoglycemic drug(s)
* Major illness/fever over the previous 1 month
* Active major cardiovascular, respiratory, liver, gastrointestinal, renal, neurological or endocrine disorders
* Coagulation disorder, on anticoagulant drug, skin disorder affecting wound healing
* Active cancer and/or oncologic treatment over the previous 12 months
* Major sleep disorder (including untreated sleep apnea syndrome), major mental illness
* Consumption of \> 7 standard units of alcohol per week for women and \> 14 standard units of alcohol per week for men
* Work and time-related criteria
* Shift work, such as evening shifts or night shifts, over the previous 1 month or planned during the study
* Travel/trip to a different time zone (≥ 2-hour time difference) over the previous 1 month or planned during the study
* Study-related criteria and other interventions
* Enrolled in another interventional clinical trial (medication, medical device) over the previous 1 month and planned during the study
* Regular medications over the previous 1 month that could affect the study endpoints (e.g. centrally acting, medications affecting gut absorption, transit or weight, hypoglycemic drug, hormonal treatment...)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
25 Years
Maximum Age:
50 Years
Study:
NCT04618133
Study Brief:
Protocol Section:
NCT04618133