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 @ 11:39 PM
Ignite Modification Date:
2025-12-24 @ 11:39 PM
NCT ID:
NCT04286451
Eligibility Criteria:
INCLUSION CRITERIA:
* Body mass index (BMI) 25-35 kg/m2 (inclusive)
* Postmenopausal (self-reported absence of menstrual cycle for 1-year)
* Within 10 years of final menstrual cycle
* Self-reported nocturnal time in bed of ≥6.5 hours per night (for ≥5 nights during a usual week)
* Willing to not take naps or engage in moderate-to-vigorous physical activity/exercise during both sleep conditions
* Willing to consume only the meals provided during both sleep conditions
* Willing to have adipose tissue and skeletal muscle biopsies
* Willing to have blood, as well as adipose and muscle tissue stored for future use
EXCLUSION CRITERIA:
* Unstable weight in the last 3 months \[gain or loss ≥5% of body weight\]
* History of clinically diagnosed diabetes or a fasting blood glucose \>126 mg/dL
* History of polycystic ovary syndrome (PCOS)
* Currently taking antihypertension medication known to affect adipose tissue and skeletal muscle metabolism (e.g., diuretics may be allowed)
* Chronic use of systemic glucocorticoids
* Chronic use of atypical antipsychotic or bipolar medications
* Initiation of antidepressant medication within the last 3 months
* Previous bariatric surgery (or other surgeries) for obesity or weight loss
* Chronic use of prescription or 'effective' over-the-counter medications affecting sleep, circadian rhythms, or glucose metabolism †
* Chronic use of hormone replacement therapy
* History of clinically diagnosed sleep apnea
* Shift workers (e.g., individuals awake or working between Midnight and 5AM)
* Inability to spend 5 nights at Pennington Biomedical
* Unwilling to eat only the food and drink provided by study staff while in the study
* Unwilling to maintain a consistent and prescribed sleep schedule while in the study
* Unwilling to maintain a consistent eating schedule while in the study
Sporadic use of certain medications is fine (however, enrollment will depend on a case-by-case basis). If taking sporadically, women should not be taking the medication for 1-month prior to the first Run-In period.
Healthy Volunteers:
True
Sex:
FEMALE
Study:
NCT04286451
Study Brief:
Protocol Section:
NCT04286451