Optimizing Recovery in Trauma Patients with Enhanced Nutrition
Official title: Optimizing Recovery in Trauma Patients: Integrating Enhanced Nutrition Delivery With Muscle Assessments, Functional Outcomes and Quality of Life
Run by Duke University · NCT06521086 · Data updated 2026-11-12
This trial tests whether adding extra protein nutrition shakes to standard care helps older adults with trauma recover better while in the hospital and for four weeks after leaving the hospital.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 45 Years and up |
| Sex | All |
| Enrollment | 60 (estimated) |
| Sponsor | Duke University Academic / other |
| Locations | 1 site (Durham, North Carolina) |
| Status | Recruiting |
| Started | February 18, 2026 |
| Main results expected | May 30, 2028 |
| Study ends | May 30, 2028 |
| Registry record updated | June 3, 2026 |
| Trial ID | NCT06521086 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults 45 years and older with trauma who can tolerate oral nutrition and have had a standard-of-care CT scan during this admission.
✕Probably not a fit
Trauma patients who cannot tolerate oral nutrition, have planned withdrawal of life-sustaining treatment within 48 hours, or have conditions like mechanical ventilation or traumatic brain injury may not benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This prospective, randomized study compares enhanced protein supplementation using oral nutrition shakes to usual nutrition guidance in critically ill, older trauma patients. Participants are randomized 1:1 to receive Fresubin KCAL drinks up to three times daily during hospitalization and for four weeks post-discharge, or to follow standard nutrition recommendations. All participants undergo non-invasive measurements of energy use, body composition, and muscle mass, plus walking and strength assessments and quality-of-life surveys at admission, around day 14 or discharge, and at one month post-discharge. The study aims to determine whether intensified nutrition improves recovery outcomes in this population.
Why it matters
Potential benefit: If successful, enhanced protein nutrition could improve muscle mass, strength, and overall recovery for older trauma patients.
How similar studies have gone: Prior research suggests nutrition optimization can influence recovery in critical illness, but this exact enhanced-protein approach in older trauma patients is being explored here.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Exclusion Criteria: * Expected withdrawal of life-sustaining treatment within 48 hours * Traumatic Brain Injury * Presence of lower extremity fracture(s) * Mechanical Ventilation * Subjects for who the Investigator would recommend a different supplement based on their medical condition. * Prisoner * Pregnancy for women of child-bearing potential
Where it's running
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Duke University Hospital
Durham, North Carolina, United States Recruiting
Study contacts
- Principal investigator: Paul Wischmeyer, MD — Duke University
- Study coordinator: Paul Wischmeyer, MD
- Email: paul.wischmeyer@duke.edu
- Phone: 919-681-9660
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.