This is a prospective, randomized, controlled trial designed to evaluate the impact of enhanced protein supplementation compared to a standard of care nutrition delivery in critically ill older adult trauma patients. Subjects will be randomized 1:1 to either enhanced nutrition or control arm. Subjects randomized to the enhanced nutrition arm will receive oral nutrition supplements (ONS) up to 3 times per day while in the hospital and for 4 weeks after discharge. Subjects in the standard of care arm will receive normal nutrition recommendations from their clinical providers. Participants in both groups will undergo non-invasive tests that measure how much energy (calories) they are using, body composition, and muscle mass.
This is a prospective, randomized, controlled trial designed to evaluate the impact of enhanced protein supplementation compared to a standard of care nutrition delivery in critically ill older adult trauma patients. Enhanced protein supplementation supports patients from ICU admission to 4-weeks post-hospital discharge, providing a comprehensive and personalized plan of care carried to completion. Subjects will be randomized 1:1 to enhanced nutrition or control arm. Subjects randomized enhanced nutrition oral nutrition supplements (Fresenius KCAL shakes) up to 3 times per day while in the hospital and for 4 weeks after discharge. Subjects in the standard of care arm will receive normal nutrition recommendations from their clinical providers. Participants in both groups will undergo non-invasive tests that measure how much energy (calories) they are using, body composition, and muscle mass. They will also be asked to complete walking and strength tests, and surveys about quality of life.These will be done at hospital admission, day 14 or hospital discharge, and at a one month post-discharge follow-up visit.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
60
Fresubin drinks will be taken up to 3 times a day throughout hospitalization and for 4 weeks after discharge.
Duke University Hospital
Durham, North Carolina, United States
Change in muscle mass as a measure of muscle quality
Time frame: Baseline to one month post-discharge (approximately six weeks)
Change in glycogen stores as a measure of muscle quality
Time frame: Baseline to one month post-discharge (approximately six weeks)
Change in body composition (percentage of a body's weight that is fat tissue) as a measure of muscle quality
Body composition is the percentage of a body's weight that is fat tissue.
Time frame: Baseline to one month post-discharge (approximately six weeks)
Change in six minute walk test (6MWT) distance
The 6MWT assesses distance walked over 6 minutes as a sub-maximal test of aerobic capacity/endurance.
Time frame: Baseline to one month post-discharge (approximately six weeks)
Change in four meter gait speed
Four meter gait speed is the time one takes to walk four meters on a level surface.
Time frame: Baseline to one month post-discharge (approximately six weeks)
Change in 30-second sit to stand test
This test measures the number of times an individual can stand from a chair with no assistance in 30 seconds. This test is used to assess functional lower body strength.
Time frame: Baseline to one month post-discharge (approximately six weeks)
Change in grip strength
Grip strength is a measure of muscular strength or the maximum force/tension generated by one's forearm muscles. It can be used as a screening tool for the measurement of upper body strength and overall strength.
Time frame: Baseline to one month post-discharge (approximately six weeks)
Change in quadriceps strength
ED (electromechanical dynamometry) can be used in either isometric or isokinetic mode. Quadriceps strength is expressed as peak knee extensor torque, which is produced at around 60° knee flexion.
Time frame: Baseline to one month post-discharge (approximately six weeks)
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.