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 @ 5:32 PM
Ignite Modification Date:
2025-12-24 @ 5:32 PM
NCT ID:
NCT00798668
Eligibility Criteria:
Inclusion Criteria:
All subjects must meet the following eligibility criteria:
* Age range: 60 years and older
* Body mass index between 20-29 kg/m2
* Weight stable (\< 2 kg weight change within last 6 months)
* Non-smoking
* Constant habitual activity patterns within last 3 months
* Clinically normal blood profiles (specifically, normal liver and kidney function; normal complete blood count (non-anemic); fasting blood glucose \<110 mg/dl)
* Not taking medications known to influence appetite or metabolism
* Non-diabetic
* Confirmation of acceptability of eating the study test foods (solids and fluids)
Trained subjects (Recruiting 36; N-25) must meet the following eligibility criteria:
* Resistive exercise training (≥ 2 times a week) based on reported physical activity levels (questionnaire)
* Active fitness level (≥ 2, 30-minute aerobic exercise sessions/week)
Sedentary subjects (Recruiting 36; N-25) must meet the following eligibility criteria:
* Resistive exercise training (≤ 1 time a week) based on reported physical activity levels (questionnaire)
* Active fitness level (≤ 2, 30-minute aerobic exercise sessions/week)
Exclusion Criteria:
All subjects will be excluded based on the following exclusionary criteria:
* Age: \<60 years
* Body mass index: outside of the 20-29 kg/m2 range
* Gained or lost \> 4.5 kg within the last 6 months
* Smoker (currently or within the last year)
* Intermittently been involved in a diet and/or exercise program within the last 3 months
* Clinically abnormal blood profiles as identified by our study physician, Arthur Rosen, MD
* Taking medications (currently or within the last 3 months) known to influence appetite or metabolism
* Abnormal heart function (interpreted by a cardiologist) and assessed (for study exclusion) by our study physician, Arthur Rosen, MD
* Clinically diagnosed as diabetic
* Study foods are found to be unacceptable for consumption by the subject
* Clinically diagnosed osteoporosis
Trained subjects will be excluded based on the following exclusionary criteria:
* Did not perform resistive exercise training (currently or within the last 3 months) based on reported physical activity levels (questionnaire)
* Perform ≤ 1, 30-minute aerobic exercise session/week (currently or within the last 3 months) based on physical activity levels questionnaire)
Sedentary subjects will be excluded based on the following exclusionary criteria:
* Performed resistive exercise training (currently or within the last 3 months) based on reported physical activity levels (questionnaire)
* Perform \> 2, 30-minute aerobic exercise sessions/week (currently or within the last 3 months) based on physical activity levels questionnaire)
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
60 Years
Study:
NCT00798668
Study Brief:
Protocol Section:
NCT00798668