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 @ 11:43 PM
Ignite Modification Date:
2025-12-24 @ 11:43 PM
NCT ID:
NCT02079051
Eligibility Criteria:
Inclusion Criteria:
* At least 65 years old at the time of the initial screening visit
* BMI greater than or equal to 35 kg/m2
Exclusion Criteria:
* Cognitive impairment (Montreal Cognitive Assessment \< 20)
* Depression (Centers for Epidemiologic Studies Depression Scale score \>16
* Recent weight change (+/- 10 lbs. in the last 12 months)
* History of non-skin cancer in the last 2 years
* Cardiovascular disease event or unstable angina within the past six months, severe pulmonary disease, renal failure
* Major liver dysfunction within the last 2 years
* Recently quit smoking less than 12 months prior
* Use of estrogen or testosterone replacement therapy
* Current use of medications for psychosis or manic-depressive illness
* Use of weight-loss medications in previous 3 months
* Dependence on others for food procurement or preparation
* Poorly controlled diabetes (HgA1c greater than or equal to 9%) or blood pressure (greater than or equal to 159 mm Hg systolic or 99 mm Hg diastolic)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
65 Years
Study:
NCT02079051
Study Brief:
Protocol Section:
NCT02079051