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:
2025-12-26 @ 4:00 PM
Ignite Modification Date:
2025-12-26 @ 4:00 PM
NCT ID:
NCT03647306
Eligibility Criteria:
Inclusion Criteria:
* Healthy overweight and obese (25 kg/m2 ≤BMI\< 40 kg/m2) men and women
* aged 30-75 years
* self-report sleeping at least 6.5-hrs/night but no more than 9-hrs/night, between 21:00 and 09:00
* signed informed consent
Exclusion Criteria:
* participation in a medically managed weight loss program within the past year
* undergone bariatric surgery
* dietary restrictions
* Subjects will not have undergone surgery, donated a unit of blood, worked night shifts or crossed any time zones, or participated in another clinical study within a month prior to the study.
* pregnancy in women
* lactating women
* Female subjects must not be actively going through menopause.
* prisoners
* inability to consent
* members of the study team
* Females with a hemoglobin \< 11.5g/dL, and males with a hemoglobin \< 13.5 g/dl will be excluded from the study.
* presence of a sleep disorder such as moderate or severe sleep apnea (AHI≥15), a Circadian Rhythm Sleep Disorder (DSM-V criteria for advance sleep phase syndrome, delayed sleep phase syndrome, non 24-h sleep disorder, irregular sleep disorder and shift-work related sleep disorder),
* a diagnosis of diabetes based on history or screening tests
* other forms of endocrine dysfunction including PCOS;
* a history of cognitive or other neurological disorders;
* a history of major psychiatric disorder based on DSM-V criteria,
* the presence of unstable or serious medical conditions,
* any GI disease that requires dietary adjustment;
* current, or use within the past month of melatonin, psychoactive, hypnotic, stimulant or pain medications (except occasionally); beta blockers; habitual smoking (6 or more cigarettes per week); caffeine consumption of greater than 500 mg per day
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
30 Years
Maximum Age:
75 Years
Study:
NCT03647306
Study Brief:
Protocol Section:
NCT03647306