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 @ 10:47 PM
Ignite Modification Date:
2025-12-24 @ 10:47 PM
NCT ID:
NCT03354169
Eligibility Criteria:
Inclusion Criteria:
* age 21-50
* BMI of 30-50 kg/m2
* stable weight (±10 lb) over the previous 6 months
* women must be pre-menopausal with regular menstrual cycles
Exclusion Criteria:
* unstable, serious medical conditions
* use of medicine linked to weight gain/loss
* cardiac conditions
* cancer
* diabetes
* autoimmune disease
* use of illicit drugs, melatonin, diuretics or hypnotics
* involved in a current weight loss program
* presence of an untreated sleep disorder (determined by surveys and actigraphy)
* those who work shift work
* those with extreme chronotypes
* habitual waking outside of 0600h-0930h
* habitual bedtime \<2200h or \>2400h
* sleep duration of \<6.5 or \>8.5 h/night.
* psychiatric exclusions will be: depression (Patient Health Questionnaire-9 score ≥9), lifetime bipolar disorder, psychosis, or eating disorder; or any other severe psychiatric disorder judged to interfere with study adherence as assessed by the MINI International Neuropsychiatric Interview.
* structured exercise \>3 d/wk, for \>30 min measured by exercise logs and actigraphy; normal activity levels are required during the study (±30 min/wk of baseline level).
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
21 Years
Maximum Age:
50 Years
Study:
NCT03354169
Study Brief:
Protocol Section:
NCT03354169