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 @ 11:36 PM
Ignite Modification Date:
2025-12-24 @ 11:36 PM
NCT ID:
NCT01427556
Eligibility Criteria:
Inclusion Criteria:
* Pre-menopausal women (as determined by self-report of menstrual history and confirmation with plasma FSH)
* 20 to 45 years old,
* BMI less than 40 kg/m2
* Stable body weight (fluctuation of less than ± 3%) for past 3 months.
* Breakfast eaters: defined as eating at least 15% of total daily energy intake at a meal between 0400-1000 h at least 6 days/week.
* Breakfast skippers: defined as eating no foods or beverages between 0400-1000h at least 4 days/week or only taking beverages (no solid food) containing less than \~100 kcal.
Exclusion Criteria:
* Erratic/intermittent breakfast eating
* Currently pregnant or lactating
* Shift workers/diagnosed sleep disorders
* Use of tobacco products
* Use of non-prescription drugs/hormone replacement/steroid-based medications
* Diagnosed endocrine, metabolic, or digestive disorder
* Hemoglobin \<11 g/dl
* Plasma Glucose \>120 mg/dl
Healthy Volunteers:
True
Sex:
FEMALE
Minimum Age:
20 Years
Maximum Age:
45 Years
Study:
NCT01427556
Study Brief:
Protocol Section:
NCT01427556