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 @ 11:46 AM
Ignite Modification Date:
2025-12-26 @ 11:46 AM
NCT ID:
NCT03835416
Eligibility Criteria:
Inclusion Criteria:
* Male Veterans
* African American or Caucasian
* Obese (BMI \> 30 kg/m2)
* Age 55+ years
* Pre-diabetes (confirmed fasting plasma glucose 100 and \<126 mg/dL) or HbA1c 5.7-6.4%
* Short Physical Performance Battery score of 4 to 11 units
* Age-normal renal function
* English speaking
* Able to record dietary intake or has a proxy who can record dietary intake
* Willing and able to be randomized to either intervention group
Exclusion Criteria:
* Presence of unstable or symptomatic life-threatening illness
* Glomerular filtration rates (GFR) less than 45 mL/min
* A GFR of 45-59 requires bi-monthly testing per the investigators' established algorithm
* Those with a GFR \<45 mL/min are excluded
* Mini Cog score of \<3
--Vegetarian
* Neurological conditions causing functional impairments, including:
* Parkinson's Disease
* multiple sclerosis
* permanent disability due to stroke
* Inability to complete physical function assessment
* History of significant weight instability
* Contraindicated medications, including narcotic mail-outs and active substance abuse
* Any psychiatric condition that would prevent the subject from participating in a group intervention setting, including diagnosed personality disorders
* Primary care provider disapproves participation
Healthy Volunteers:
False
Sex:
MALE
Minimum Age:
55 Years
Study:
NCT03835416
Study Brief:
Protocol Section:
NCT03835416