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 @ 7:33 PM
Ignite Modification Date:
2025-12-24 @ 7:33 PM
NCT ID:
NCT03459703
Eligibility Criteria:
Inclusion Criteria:
* Are a new patient at the UAB Weight Loss Medicine Clinic
* Aged 25-75 years old
* BMI between 30-60 kg/m2 (inclusive)
* Weigh less than 450 lbs
* Wake up regularly between 4-9 am on most days.
Exclusion Criteria:
* Diagnosed with diabetes, have an HbA1c of ≥6.5%, or are on diabetes medication
* On weight loss medication
* Addition of or withdrawal from a chronic medication within the past 10 weeks
* Clinically significant laboratory abnormality (e.g., abnormal hemoglobin levels)
* Significant gastrointestinal disease, major gastrointestinal surgery, or gallstones
* Significant cardiovascular, renal, cardiac, liver, lung, adrenal, or nervous system disease that might compromise the participant's safety or data validity
* Evidence of cancer (other than non-melanoma skin cancer) within the last 5 years
* Unstable psychiatric, sleep, or circadian conditions (common conditions such as sleep apnea and depression are acceptable as long as they are stabilized and not rapidly worsening)
* Lost or gained more than 5 lbs of weight in the past month
* Currently perform overnight shift work more than once per week on average
* Regularly eat within a less than 10-hour period each day
* Regularly eat dinner before 6 pm
* Traveled more than two time zones away in the two months prior to enrolling in the trial
* Will travel more than one time zone away during the study
* Pregnant or breastfeeding
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
25 Years
Maximum Age:
75 Years
Study:
NCT03459703
Study Brief:
Protocol Section:
NCT03459703