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 @ 10:20 PM
Ignite Modification Date:
2025-12-26 @ 10:20 PM
NCT ID:
NCT05628012
Eligibility Criteria:
Inclusion Criteria:
1\. Healthy, overweight or obese individuals.
Exclusion Criteria:
1. Participants must have a body mass index (BMI) greater than or equal to 27 kilograms per meter squared.
2. No history of drug or alcohol dependency. Must be current non-smokers, and are required to have a history of less than 5 pack years of smoking.
3. No history of working irregular day and night hours, regular night work, or rotating shift work for the 1 year prior to the study. In addition to this, individuals must not have traveled across more than 1 time zone during the 3 months prior to the study.
4. Chronobiologic and sleep disorders.
5. Diseases of the cardiovascular system.
6. Hypertension. Individuals will be allowed to be normotensive (resting systolic blood pressure of \<140/90 mmHg, measured on more than one occasion) or uncomplicated stage 1 hypertension (systolic BP between 140 and 159 mmHg or a diastolic BP between 90 and 99 mmHg).
7. Disorders of the respiratory system.
8. Pre-diabetes/Diabetes. For participants who have a fasting blood glucose level that is greater than or equal to 100 mg/dL, the investigators will measure hemoglobin A1c to exclude for diabetes (HbA1c\>5.7%).
9. Disorders of the kidney and urinary tract.
10. Infectious diseases.
11. Disorders of the gastrointestinal system.
12. Disorders of the immune system.
13. Disorders of the hematopoietic system.
14. Neoplastic diseases.
15. Endocrine and metabolic diseases.
16. Neurologic disorders.
17. Must not be participating in another research study that would influence their safe participation in the study.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
40 Years
Study:
NCT05628012
Study Brief:
Protocol Section:
NCT05628012