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 @ 2:54 AM
Ignite Modification Date:
2025-12-25 @ 2:54 AM
NCT ID:
NCT05290233
Eligibility Criteria:
Inclusion Criteria:
* Adults with obesity (BMI between 30-50kg/m2)
* pre-diabetes (fasting glucose: 100-125 mg/dl or HBA1c 5.7%-6.4% or OGTT ≥ 200 mg/dl)
* sedentary or lightly active (\<7,500 steps/day)
* between the ages of 50-80 years
Exclusion Criteria:
* diagnosed with T1DM or T2DM (fasting glucose: \>126 mg/dl, 2-h glucose OGTT ≥ 200 mg/dl,
* HbA1c: \>6.5%)
* Individuals with a history of eating disorders
* shift workers
* Individuals taking drugs to control body weight and glucose (including metformin)
* individuals who are not weight stable (weight gain or loss \> 4 kg) 3 months prior to the intervention
* mobility disorders or individuals unable to exercise for 40-60 minutes 3-4 days/week
* Individuals diagnosed with comorbidities impacting cognition, including major/mild neurocognitive disorder, cerebrovascular disease (e.g., stroke, aneurysm, arteriovenous malformation), traumatic brain injury, epilepsy, or major psychiatric disorder (e.g., schizophrenia, bipolar disorder, substance use disorder)
* Individuals who are unable to adequately report dietary intake or physical activity
* Smokers
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
50 Years
Maximum Age:
80 Years
Study:
NCT05290233
Study Brief:
Protocol Section:
NCT05290233