Optimizing Recovery in Trauma Patients by Integrating Enhanced Nutrition Delivery
Recruiting now · Not applicable
Conditions studied: Trauma, Critical Illness
In brief
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.
Key facts
- Study ID
- NCT06521086
- Run by
- Duke University
- People needed
- 60
- Starts
- 2026-02-18
- Expected to finish
- 2028-05-30
- Last updated by the study team
- 2026-06-03
Who can join
Age: 45 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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 is running
- Duke University Hospital — Durham, North Carolina, United States (enrolling)
Full record on ClinicalTrials.gov
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