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 @ 1:28 AM
Ignite Modification Date:
2025-12-25 @ 1:28 AM
NCT ID:
NCT06070194
Eligibility Criteria:
Inclusion Criteria:
* Age: 18-45 years
* BMI: 25-35 kg/m2
* Habitual sleep duration: ≤6.5 h/night
* Habitual eating period: \>14h/day
* Absence of chronic health conditions including hypertension (defined as systolic clinical BP of \>140 or diastolic BP of \>90 mmHg or use of BP lowering drugs), dyslipidemia (defined as LDL \>190mg/dL or Triglycerides \>400 mg/dL or use of lipid lowering medications), diabetes (defined as fasting glucose \>126 mg/dL and /or HbA1C \>6.5%, or use of glucose lowering medication), and cardiovascular disease. However, individuals with prehypertension, and/or prediabetes will be allowed to participate.
* Individuals with seasonal allergies will also be included.
* Women of child-bearing age will be allowed to participate if they agree to use acceptable birth control during the study period.
* Must be able to provide written informed consent.
* Ability to follow the prescribed eating duration and maintain habitual diet, sleep and physical activity.
* Use of certain mediations will be allowed including birth control, second generation antihistamines, antacids, acne-related ointments etc.
Exclusion Criteria:
* Irregular sleep habits / night shift / rotating shift work in past 1 month.
* Frequent travel related jet lag.
* Pregnant/ breast-feeding/ history of irregular menstrual cycles.
* Sleep disorders such as insomnia (defined as Insomnia Severity Index score ≥15), and sleep apnea (overnight oximetry defined oxygen desaturation index of \>10 events/h of sleep).
* Presence of excessive daytime sleepiness (defined as Epworth Sleepiness Scale score \>10).
* Recent changes in body weight (≥5%) within 3 months.
* Uncontrolled depression and /or anxiety, history of psychosis or bipolar disorder.
* Uncontrolled depression and/or depression is defined as PHQ-9 score of ≥15 or a positive response for suicidal thoughts (Q9 of the PHQ-9 - any response other than not at all).
* Any medication or condition that, in the opinion of the medical investigator, could interfere with the study outcomes or put the subject at risk by participating in the study.
* Blood or plasma donation during the past 2 months.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
45 Years
Study:
NCT06070194
Study Brief:
Protocol Section:
NCT06070194