Optimizing Recovery in Trauma Patients by Integrating Enhanced Nutrition Delivery
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age45+
SponsorDuke University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients who are at least 45 years old and presented to the Emergency Department as a leveled trauma
Patients who have the ability to tolerate oral nutrition
Patients who have had a standard of care CT scan this admission
Disqualifiers
Expected withdrawal of life-sustaining treatment within 48 hours
Traumatic Brain Injury
Presence of lower extremity fracture(s)
Mechanical Ventilation
Trial design
Design model
Parallel
Treatments tested in this trial
Nutrition Supplements - Fresubin KCAL Drinks
Dietary supplementFresubin drinks will be taken up to 3 times a day throughout hospitalization and for 4 weeks after discharge.
Treatment groups
60 Participants
are divided into 2 treatment groupsGroup A: Enhanced Protein SupplementationExperimental treatment 1 intervention
Group B: Control PathwayNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
Change in muscle mass as a measure of muscle quality
Time frame
Baseline to one month post-discharge (approximately six weeks)2
Change in glycogen stores as a measure of muscle quality
Time frame
Baseline to one month post-discharge (approximately six weeks)3
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)Secondary outcomes
1
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)2
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)3
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)4
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)Sponsors and contacts
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Source ClinicalTrials.gov