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 @ 2:49 AM
Ignite Modification Date:
2025-12-25 @ 2:49 AM
NCT ID:
NCT04328233
Eligibility Criteria:
Inclusion Criteria:
1. Metabolic syndrome, defined as the presence of elevated fasting plasma glucose ≥ 100 mg/dL and two or more of the following criteria:
Elevated waist circumference: ≥ 102 cm in men, ≥ 88 cm in women; Fasting plasma triglycerides ≥ 150 mg/dL (or on drug treatment for elevated triglycerides); Reduced High-density lipoprotein (HDL)-cholesterol \< 40 mg/dL in men, \< 50 mg/dL in women (or drug treatment for reduced HDL-cholesterol); Elevated blood pressure, Systolic blood pressure ≥ 130 mm Hg and/or diastolic blood pressure ≥ 85 mm Hg (or drug treatment for hypertension).
2. BMI \> 25
3. Duration of eating period ≥ 14 hours/day.
4. Own a Smartphone with Apple Operating System (OS) or Android OS.
Exclusion Criteria:
1. Diagnosis of diabetes.
2. Pregnant or lactating women.
3. Active smoking or illicit drug use or history of treatment for alcohol abuse.
4. Shift work.
5. Caregivers for dependent requiring nocturnal care.
6. Planned travel over time zones during the study period.
7. History of major adverse cardiovascular event within the past 1 year (acute coronary syndrome, percutaneous coronary intervention, coronary artery bypass graft surgery, hospitalization for congestive heart failure, stroke/transient ischemic attack) or current uncontrolled arrhythmia.
8. Uncontrolled medical conditions due to rheumatologic, hematologic, oncologic, infectious, gastrointestinal, psychiatric, nephrological, or endocrine diseases.
9. Known history of an eating disorder.
10. Currently enrolled in a weight-loss or weight-management program.
11. Special or prescribed diet for other reasons (e.g. Celiac disease).
12. Current treatment with antidepressants, medications affecting appetite, or immunosuppression.
13. History of bariatric surgery.
14. A score of \> 16 on the Epworth Sleepiness Scale.
15. Depression determined by the Beck Depression Inventory.
16. Failure to use the smartphone app for documentation during a 2-week baseline period.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT04328233
Study Brief:
Protocol Section:
NCT04328233